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

18 janvier 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Brussels, Belgique, 1020
        • CHU Brugmann

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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%.
Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of hypoxemia episodes (Sp02<90%)
Délai: 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%)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of recruitment manoeuvers
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Van Hecke Delphine, MD, CHU Brugmann

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2013

Achèvement primaire (Réel)

1 décembre 2015

Achèvement de l'étude (Réel)

1 mars 2016

Dates d'inscription aux études

Première soumission

12 octobre 2015

Première soumission répondant aux critères de contrôle qualité

16 octobre 2015

Première publication (Estimation)

20 octobre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 janvier 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 janvier 2018

Dernière vérification

1 janvier 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CHUB-CRF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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