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Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?

18 stycznia 2018 zaktualizowane przez: Philippe VAN DER LINDEN, Brugmann University Hospital

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Brussels, Belgia, 1020
        • CHU Brugmann

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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%.
Aktywny 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of hypoxemia episodes (Sp02<90%)
Ramy czasowe: 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%)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of recruitment manoeuvers
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Van Hecke Delphine, MD, CHU Brugmann

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2013

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2015

Ukończenie studiów (Rzeczywisty)

1 marca 2016

Daty rejestracji na studia

Pierwszy przesłany

12 października 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 października 2015

Pierwszy wysłany (Oszacować)

20 października 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 stycznia 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 stycznia 2018

Ostatnia weryfikacja

1 stycznia 2018

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CHUB-CRF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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Badania kliniczne na Chirurgiczne leczenie otyłości

Badania kliniczne na PEEP (positive end-expiratory pressure)

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