- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02579798
Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?
General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used.
The functional residual capacity (FRC) of obese patients during general anesthesia is even smaller than the one of healthy patients. There is a direct relationship between the body mass index and the decrease of the functional residual capacity. Obese patients have therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will increase the decrease of the CRF, and thus aggravate the formation of these atelectasis.
Atelectasis affect the peroperative gas exchanges and are likely to be involved in the worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance of secretions and the lymph flow, which predispose to lung infections.Taking all these factors into account, it is logical to think that the atelectasis presence can lead to an increase of the postsurgical morbidity (respiratory distress, infections). That is why actively fighting against the formation of these atelectasis is important.
There is a lack of scientific evidence to say that the strategies against atelectasis as PEEP have a significant impact on the patient's postoperative status. The expected clinical benefits balance (reduction of respiratory distress episodes, infections and mortality) versus the risks linked to the maneuvers done to reduce the development of atelectasis (barotraumas, cardiac complications) remains to be determined.
The primary goal of this study is to evaluate the impact of two different alveolar recruitment strategies on the incidence of postoperative hypoxemia in obese patients after bariatric surgery.
The secondary objectives of this study are to compare the number of recruitment maneuvers, the Pa02 / FI02 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen), the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2 gradient (arterial and end tidal gradient) between two alveolar recruitment strategies applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy).
The tertiary objectives of this study are to report the number of respiratory complications and postoperative wound infections at the 30th postoperative day.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of healthy patients in the minutes following the induction when a positive end expiratory pressure (PEEP) is not used.
These atelectasis are formed on one hand by the reduction of the functional residual capacity (FRC) following a compression mechanism (loss of the inspiratory muscle tone, which is accompanied by a chest wall configuration change and a diaphragm cephalic movement) and on the other hand by a denitrogenation absorption process (ventilation at high Fi02 (oxygen inspired fraction) causing complete absorption of O2 with lack of support for the alveolus, which then collapses).
The FRC of obese patients during general anesthesia is even smaller than the one of healthy patients. There is a direct relationship between the body mass index and the decrease of the functional residual capacity. Obese patients have therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will increase the decrease of the CRF, and thus aggravate the formation of these atelectasis.
Atelectasis affect the peroperative gas exchanges and are likely to be involved in the worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance of secretions and the lymph flow, which predispose to lung infections.Taking all these factors into account, it is logical to think that the atelectasis presence can lead to an increase of the postsurgical morbidity (respiratory distress, infections). That is why actively fighting against the formation of these atelectasis is important.
Several strategies have been studied in order to improve respiratory mechanics and reduce impaired gas exchange during laparoscopic surgery in obese patients. The position called "chair", mechanical ventilation with PEEP, recruitment maneuvers followed by the PEEP, and spontaneous ventilation with CPAP before extubation, are all strategies that have proven effective to decrease development these atelectasis.
Currently, the scientific community agrees on the fact that PEEP improves intraoperative respiratory function (improved compliance, oxygenation) especially in conjunction with recruitment maneuvers.
But there is a lack of scientific evidence to say that the strategies against atelectasis as PEEP have a significant impact on the patient's postoperative status. The expected clinical benefits balance (reduction of respiratory distress episodes, infections and mortality) versus the risks linked to the maneuvers done to reduce the development of atelectasis (barotraumas, cardiac complications) remains to be determined.
The primary goal of this study is to evaluate the impact of two different alveolar recruitment strategies on the incidence of postoperative hypoxemia in obese patients after bariatric surgery.
The secondary objectives of this study are to compare the number of recruitment maneuvers, the Pa02 / FI02 ratio, the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2 gradient between two alveolar recruitment strategies applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy).
The tertiary objectives of this study are to report the number of respiratory complications and postoperative wound infections at the 30th postoperative day.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Brussels, Belgien, 1020
- CHU Brugmann
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- ASA score (American Society of Anesthesiologists ) of II or III
- BMI > 35 kg/m²
- Elective laparoscopic bariatric surgery: gastric bypass or sleeve
Exclusion Criteria:
- Restrictive (CPT <65%) or obstructive (VEMS/CV < 69%) chronic lung disease
- Increase of the intracranial pressure
- History of smoking with chronic obstructive disease (VEMS/CV)
- Active tabagism
- Ongoing pregnancy
- History of heart failure (NYHA III or IV) or coronary artery disease
- Urgent surgery
- Allergy to a drug used within the study
- Lack of written informed consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: PEEP 10 cmH20
In this group, a PEEP of 10 cmH20 is applied for the duration of the intervention and a recruitment maneuver is applied each time the SpO2 (oxygen pulsated saturation) drops below 95%.
|
|
Aktiv komparator: optimal PEEP
In this group, 10 cmH20 PEEP is applied immediately.
Then the "optimal PEEP" is sought at three key moments.
It is determined by the best value of lung compliance found in the patient.
It is sought by increasing or decreasing the value of the PEEP by increments or decrements of 2 cmH20.
If after 6 respiratory cycles, the value of the compliance is increased, the investigator continues to increase the value of the PEEP.
On the other hand, if the value of compliance is reduced, the investigator reduces the value of PEEP.
The value of the PEEP selected shall in no event exceed the set pressure range (maximum pressure plate of 30 cmH20 and maximum inspiratory peak pressure 40cmH20).
A recruitment maneuver is applied each time the SpO2 drops below 95%, as in the PEEP 10cmH2O group.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of hypoxemia episodes (Sp02<90%)
Tidsram: continuously during 48h after surgery
|
This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany).
This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<90%) and their duration in obese patients, in the postoperative period.
|
continuously during 48h after surgery
|
Number of hypoxemia episodes (Sp02<95%)
Tidsram: continuously during 48h after surgery
|
This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany).
This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<95%) and their duration in obese patients, in the postoperative period.
|
continuously during 48h after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of recruitment manoeuvers
Tidsram: From the beginning of the surgery till moment 1 (after induction/intubation, patient laying flat, without pneumoperitoneum)
|
Recruitment manoeuver are performed if patient saturation drops below 95%.
|
From the beginning of the surgery till moment 1 (after induction/intubation, patient laying flat, without pneumoperitoneum)
|
Number of recruitment manoeuvers
Tidsram: From moment 1 till moment 2 (after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation)
|
Recruitment manoeuver are performed if patient saturation drops below 95%.
|
From moment 1 till moment 2 (after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation)
|
Number of recruitment manoeuvers
Tidsram: From moment 2 till moment 3 (after pneumoperitoneum exsufflation - patient lying flat)
|
Recruitment manoeuver are performed if patient saturation drops below 95%.
|
From moment 2 till moment 3 (after pneumoperitoneum exsufflation - patient lying flat)
|
Number of recruitment manoeuvers
Tidsram: From moment 3 till the end of the surgery (patient leaving the theater)
|
Recruitment manoeuver are performed if patient saturation drops below 95%.
|
From moment 3 till the end of the surgery (patient leaving the theater)
|
Pulmonary dynamic compliance (Cd) - preoperative
Tidsram: Just before surgery, at ambient air contact
|
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
|
Just before surgery, at ambient air contact
|
Pulmonary dynamic compliance (Cd) - moment 1
Tidsram: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
|
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
|
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
|
Pulmonary dynamic compliance (Cd) -moment 2
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Pulmonary dynamic compliance (Cd) -moment 3
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
|
just after pneumoperitoneum exsufflation - patient lying flat
|
Pulmonary dynamic compliance (Cd) -if recruitment manoeuvers
Tidsram: Five minutes after any recruitment manoeuver
|
This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
|
Five minutes after any recruitment manoeuver
|
Anatomic dead space - preoperative
Tidsram: Just before surgery, at ambient air contact
|
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
|
Just before surgery, at ambient air contact
|
Anatomic dead space -moment 1
Tidsram: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
|
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
|
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
|
Anatomic dead space -moment 2
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Anatomic dead space -moment 3
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
|
just after pneumoperitoneum exsufflation - patient lying flat
|
Anatomic dead space -if recruitment manoeuvers
Tidsram: Five minutes after any recruitment manoeuver
|
This will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
|
Five minutes after any recruitment manoeuver
|
PaO2/FiO2 ratio - preoperative
Tidsram: Just before surgery, at ambient air contact
|
Arterial oxygen partial pressure to fractional inspired oxygen ratio
|
Just before surgery, at ambient air contact
|
PaO2/FiO2 ratio - moment 1
Tidsram: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
|
Arterial oxygen partial pressure to fractional inspired oxygen ratio
|
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
|
PaO2/FiO2 ratio - moment 2
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Arterial oxygen partial pressure to fractional inspired oxygen ratio
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
PaO2/FiO2 ratio - moment 3
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
Arterial oxygen partial pressure to fractional inspired oxygen ratio
|
just after pneumoperitoneum exsufflation - patient lying flat
|
PaO2/FiO2 ratio - if recruitment manoeuvers
Tidsram: Five minutes after any recruitment manoeuver
|
Arterial oxygen partial pressure to fractional inspired oxygen ratio
|
Five minutes after any recruitment manoeuver
|
PaCO2-EtCO2 gradient - preoperative
Tidsram: Just before surgery, at ambient air contact
|
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
|
Just before surgery, at ambient air contact
|
PaCO2-EtCO2 gradient - moment 1
Tidsram: just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
|
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
|
just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory
|
PaCO2-EtCO2 gradient - moment 2
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
PaCO2-EtCO2 gradient - moment 3
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
|
just after pneumoperitoneum exsufflation - patient lying flat
|
PaCO2-EtCO2 gradient - if recruitment manoeuvers
Tidsram: Five minutes after any recruitment manoeuver
|
The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment.
|
Five minutes after any recruitment manoeuver
|
Number of respiratory complications
Tidsram: 30 days after surgery
|
Number of hospitalisations due to respiratory complications within 30 days after surgery.
|
30 days after surgery
|
Number of postoperative wound infections
Tidsram: 30 days after surgery
|
All patients are seen at the surgical consultation on day 30 after surgery.
The anamnesis performed during that consultation enables the investigators to identify patients with wound infections (defined as a need for local or oral antibiotics, additional hospitalisation or abnormal cicatrisation).
|
30 days after surgery
|
Pre-operative physiologic measures: cardiac frequency (FC)
Tidsram: Just before surgery, at ambient air contact
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
Just before surgery, at ambient air contact
|
Pre-operative physiologic measures: Arterial tension (TA)
Tidsram: Just before surgery, at ambient air contact
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
Just before surgery, at ambient air contact
|
Pre-operative physiologic measures: pH
Tidsram: Just before surgery, at ambient air contact
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
Just before surgery, at ambient air contact
|
Pre-operative physiologic measures: partial pressure of carbon dioxide in the arterial blood (PaCO2)
Tidsram: Just before surgery, at ambient air contact
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens).
|
Just before surgery, at ambient air contact
|
Operative physiologic measures - moment 1: FC
Tidsram: just after induction/intubation, patient laying flat, without pneumoperitoneum
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
just after induction/intubation, patient laying flat, without pneumoperitoneum
|
Operative physiologic measures - moment 1: PAM (Average arterial pressure)
Tidsram: just after induction/intubation, patient laying flat, without pneumoperitoneum
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
just after induction/intubation, patient laying flat, without pneumoperitoneum
|
Operative physiologic measures - moment 1: pH
Tidsram: just after induction/intubation, patient laying flat, without pneumoperitoneum
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
just after induction/intubation, patient laying flat, without pneumoperitoneum
|
Operative physiologic measures - moment 1: PaCO2
Tidsram: just after induction/intubation, patient laying flat, without pneumoperitoneum
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after induction/intubation, patient laying flat, without pneumoperitoneum
|
Operative physiologic measures - moment 1: CO2
Tidsram: just after induction/intubation, patient laying flat, without pneumoperitoneum
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after induction/intubation, patient laying flat, without pneumoperitoneum
|
Operative physiologic measures - moment 2: FC
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Operative physiologic measures - moment 2: PAM
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Operative physiologic measures - moment 2: pH
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Operative physiologic measures - moment 2: PaCO2
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Operative physiologic measures - moment 2: CO2
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Operative physiologic measures - moment 3: FC
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
just after pneumoperitoneum exsufflation - patient lying flat
|
Operative physiologic measures - moment 3: PAM
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
just after pneumoperitoneum exsufflation - patient lying flat
|
Operative physiologic measures - moment 3: pH
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
just after pneumoperitoneum exsufflation - patient lying flat
|
Operative physiologic measures - moment 3: CO2
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after pneumoperitoneum exsufflation - patient lying flat
|
Operative physiologic measures - moment 3: PaCO2
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after pneumoperitoneum exsufflation - patient lying flat
|
Operative physiologic measures - if recruitment manoeuvers occurs: FC
Tidsram: Five minutes after any recruitment manoeuver
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
Five minutes after any recruitment manoeuver
|
Operative physiologic measures - if recruitment manoeuvers occurs: PAM
Tidsram: Five minutes after any recruitment manoeuver
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
Five minutes after any recruitment manoeuver
|
Operative physiologic measures - if recruitment manoeuvers occurs: SpO2
Tidsram: Five minutes after any recruitment manoeuver
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
Five minutes after any recruitment manoeuver
|
Operative physiologic measures - if recruitment manoeuvers occurs: pH
Tidsram: Five minutes after any recruitment manoeuver
|
The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
|
Five minutes after any recruitment manoeuver
|
Operative physiologic measures - if recruitment manoeuvers occurs: PaCO2
Tidsram: Five minutes after any recruitment manoeuver
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
Five minutes after any recruitment manoeuver
|
Operative physiologic measures - if recruitment manoeuvers occurs: PaO2
Tidsram: Five minutes after any recruitment manoeuver
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
Five minutes after any recruitment manoeuver
|
Operative physiologic measures - if recruitment manoeuvers occurs: CO2
Tidsram: Five minutes after any recruitment manoeuver
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
Five minutes after any recruitment manoeuver
|
Pre-operative physiologic measures: partial pressure of oxygen in the arterial blood (PaO2)
Tidsram: Just before surgery, at ambient air contact
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
Just before surgery, at ambient air contact
|
Operative physiologic measures - moment 1: PaO2
Tidsram: just after induction/intubation, patient laying flat, without pneumoperitoneum
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after induction/intubation, patient laying flat, without pneumoperitoneum
|
Operative physiologic measures - moment 2: PaO2
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Operative physiologic measures - moment 3: PaO2
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after pneumoperitoneum exsufflation - patient lying flat
|
Pre-operative physiologic measures: Oxygen Pulsated Saturation (SpO2)
Tidsram: Just before surgery, at ambient air contact
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
Just before surgery, at ambient air contact
|
Operative physiologic measures - moment 1: SpO2
Tidsram: just after induction/intubation, patient laying flat, without pneumoperitoneum
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after induction/intubation, patient laying flat, without pneumoperitoneum
|
Operative physiologic measures - moment 2: SpO2
Tidsram: just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation
|
Operative physiologic measures - moment 3: SpO2
Tidsram: just after pneumoperitoneum exsufflation - patient lying flat
|
The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
|
just after pneumoperitoneum exsufflation - patient lying flat
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Van Hecke Delphine, MD, CHU Brugmann
Publikationer och användbara länkar
Allmänna publikationer
- Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.
- Gander S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Positive end-expiratory pressure during induction of general anesthesia increases duration of nonhypoxic apnea in morbidly obese patients. Anesth Analg. 2005 Feb;100(2):580-584. doi: 10.1213/01.ANE.0000143339.40385.1B.
- Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
- Maisch S, Reissmann H, Fuellekrug B, Weismann D, Rutkowski T, Tusman G, Bohm SH. Compliance and dead space fraction indicate an optimal level of positive end-expiratory pressure after recruitment in anesthetized patients. Anesth Analg. 2008 Jan;106(1):175-81, table of contents. doi: 10.1213/01.ane.0000287684.74505.49.
- Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.
- Whalen FX, Gajic O, Thompson GB, Kendrick ML, Que FL, Williams BA, Joyner MJ, Hubmayr RD, Warner DO, Sprung J. The effects of the alveolar recruitment maneuver and positive end-expiratory pressure on arterial oxygenation during laparoscopic bariatric surgery. Anesth Analg. 2006 Jan;102(1):298-305. doi: 10.1213/01.ane.0000183655.57275.7a. Erratum In: Anesth Analg. 2006 Mar;102(3):881.
- Pelosi P, Ravagnan I, Giurati G, Panigada M, Bottino N, Tredici S, Eccher G, Gattinoni L. Positive end-expiratory pressure improves respiratory function in obese but not in normal subjects during anesthesia and paralysis. Anesthesiology. 1999 Nov;91(5):1221-31. doi: 10.1097/00000542-199911000-00011.
- Imberger G, McIlroy D, Pace NL, Wetterslev J, Brok J, Moller AM. Positive end-expiratory pressure (PEEP) during anaesthesia for the prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007922. doi: 10.1002/14651858.CD007922.pub2.
- Futier E, Constantin JM, Pelosi P, Chanques G, Kwiatkoskwi F, Jaber S, Bazin JE. Intraoperative recruitment maneuver reverses detrimental pneumoperitoneum-induced respiratory effects in healthy weight and obese patients undergoing laparoscopy. Anesthesiology. 2010 Dec;113(6):1310-9. doi: 10.1097/ALN.0b013e3181fc640a.
- Almarakbi WA, Fawzi HM, Alhashemi JA. Effects of four intraoperative ventilatory strategies on respiratory compliance and gas exchange during laparoscopic gastric banding in obese patients. Br J Anaesth. 2009 Jun;102(6):862-8. doi: 10.1093/bja/aep084. Epub 2009 Apr 29.
- Tusman G, Bohm SH, Suarez-Sipmann F, Turchetto E. Alveolar recruitment improves ventilatory efficiency of the lungs during anesthesia. Can J Anaesth. 2004 Aug-Sep;51(7):723-7. doi: 10.1007/BF03018433.
- Strang CM, Hachenberg T, Freden F, Hedenstierna G. Development of atelectasis and arterial to end-tidal PCO2-difference in a porcine model of pneumoperitoneum. Br J Anaesth. 2009 Aug;103(2):298-303. doi: 10.1093/bja/aep102. Epub 2009 May 13.
- Hans GA, Sottiaux TM, Lamy ML, Joris JL. Ventilatory management during routine general anaesthesia. Eur J Anaesthesiol. 2009 Jan;26(1):1-8. doi: 10.1097/EJA.0b000e000000f1fb.
- Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55. doi: 10.1001/jama.299.6.646.
- Gattinoni L, Carlesso E, Brazzi L, Caironi P. Positive end-expiratory pressure. Curr Opin Crit Care. 2010 Feb;16(1):39-44. doi: 10.1097/MCC.0b013e3283354723.
- Van Hecke D, Bidgoli JS, Van der Linden P. Does Lung Compliance Optimization Through PEEP Manipulations Reduce the Incidence of Postoperative Hypoxemia in Laparoscopic Bariatric Surgery? A Randomized Trial. Obes Surg. 2019 Apr;29(4):1268-1275. doi: 10.1007/s11695-018-03662-x.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHUB-CRF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Bariatrisk kirurgi
-
Hospices Civils de LyonAvslutadMatpreferenser Variationer beroende på Bariatric Surgery StatusFrankrike
-
AstraZenecaAvslutad
-
University College DublinAvslutad
-
Universitaire Ziekenhuizen KU LeuvenUniversity Hospital, Ghent; University Hospital, Antwerp; Imelda Hospital... och andra samarbetspartnersRekryteringBariatric Surgery Status som komplicerar graviditetenBelgien
-
Odense University HospitalRekryteringFettvävnadsdysfunktion Typ 2 Diabetes Mellitus Bariatric SurgeryDanmark
-
Chelsea and Westminster NHS Foundation TrustRekryteringFetma | Graviditetskomplikationer | Graviditetsrelaterad | Bariatric Surgery Status som komplicerar graviditeten | Graviditet hos diabetikerStorbritannien
-
Sana Klinikum OffenbachWuerzburg University Hospital; Kuwait University; Cleveland Clinic Florida; SRH Wald-Klinikum Gera GmbHAvslutadBariatric Surgery Status i T1DTyskland
-
Assistance Publique - Hôpitaux de ParisRekryteringBariatric Surgery Status som komplicerar graviditeten | Sleeve Gastrectomy | Tillväxthämning i livmodernFrankrike
-
Medistim ASAHar inte rekryterat ännuCardiac Bypass Surgery (CABG)
-
Assistance Publique Hopitaux De MarseilleOkänd
Kliniska prövningar på PEEP (positive end-expiratory pressure)
-
Murdoch Childrens Research InstituteUniversity of Pennsylvania; University of Oxford; Academisch Medisch Centrum...RekryteringFör tidig födsel | LungskadaFörenta staterna, Australien, Österrike, Italien, Nederländerna, Storbritannien, Polen, Frankrike
-
Columbia UniversityRekryteringPostoperativa lungkomplikationerFörenta staterna