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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02579798
Enrollment
100
Registered
2015-10-20
Start date
2013-07-31
Completion date
2016-03-31
Last updated
2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

Keywords

Bariatric surgery, Post-surgery hypoxemia, Obesity

Brief summary

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.

Detailed description

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.

Interventions

DEVICEPEEP (positive end-expiratory pressure)

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of hypoxemia episodes (Sp02<90%)continuously during 48h after surgeryThis 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.
Number of hypoxemia episodes (Sp02<95%)continuously during 48h after surgeryThis 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.

Secondary

MeasureTime frameDescription
Pulmonary dynamic compliance (Cd) - moment 1just after the anesthesia induction/intubation, patient laying flat, without pneumoperitoryThis will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Pulmonary dynamic compliance (Cd) -moment 2just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThis will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Pulmonary dynamic compliance (Cd) -moment 3just after pneumoperitoneum exsufflation - patient lying flatThis will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Pulmonary dynamic compliance (Cd) -if recruitment manoeuversFive minutes after any recruitment manoeuverThis will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O
Anatomic dead space - preoperativeJust before surgery, at ambient air contactThis will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Anatomic dead space -moment 1just after the anesthesia induction/intubation, patient laying flat, without pneumoperitoryThis will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Anatomic dead space -moment 2just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThis will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Anatomic dead space -moment 3just after pneumoperitoneum exsufflation - patient lying flatThis will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
Anatomic dead space -if recruitment manoeuversFive minutes after any recruitment manoeuverThis will be determined by this formula: VD = VT (1-PEtCO2/PaC02)
PaO2/FiO2 ratio - preoperativeJust before surgery, at ambient air contactArterial oxygen partial pressure to fractional inspired oxygen ratio
PaO2/FiO2 ratio - moment 1just after the anesthesia induction/intubation, patient laying flat, without pneumoperitoryArterial oxygen partial pressure to fractional inspired oxygen ratio
PaO2/FiO2 ratio - moment 2just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationArterial oxygen partial pressure to fractional inspired oxygen ratio
PaO2/FiO2 ratio - moment 3just after pneumoperitoneum exsufflation - patient lying flatArterial oxygen partial pressure to fractional inspired oxygen ratio
PaO2/FiO2 ratio - if recruitment manoeuversFive minutes after any recruitment manoeuverArterial oxygen partial pressure to fractional inspired oxygen ratio
PaCO2-EtCO2 gradient - preoperativeJust before surgery, at ambient air contactThe 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.
PaCO2-EtCO2 gradient - moment 1just after the anesthesia induction/intubation, patient laying flat, without pneumoperitoryThe 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.
PaCO2-EtCO2 gradient - moment 2just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThe 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.
PaCO2-EtCO2 gradient - moment 3just after pneumoperitoneum exsufflation - patient lying flatThe 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.
PaCO2-EtCO2 gradient - if recruitment manoeuversFive minutes after any recruitment manoeuverThe 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.
Number of respiratory complications30 days after surgeryNumber of hospitalisations due to respiratory complications within 30 days after surgery.
Number of postoperative wound infections30 days after surgeryAll 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).
Pre-operative physiologic measures: cardiac frequency (FC)Just before surgery, at ambient air contactThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Pre-operative physiologic measures: Arterial tension (TA)Just before surgery, at ambient air contactThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Pre-operative physiologic measures: pHJust before surgery, at ambient air contactThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Pre-operative physiologic measures: partial pressure of carbon dioxide in the arterial blood (PaCO2)Just before surgery, at ambient air contactThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens).
Operative physiologic measures - moment 1: FCjust after induction/intubation, patient laying flat, without pneumoperitoneumThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 1: PAM (Average arterial pressure)just after induction/intubation, patient laying flat, without pneumoperitoneumThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 1: pHjust after induction/intubation, patient laying flat, without pneumoperitoneumThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 1: PaCO2just after induction/intubation, patient laying flat, without pneumoperitoneumThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 1: CO2just after induction/intubation, patient laying flat, without pneumoperitoneumThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 2: FCjust after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 2: PAMjust after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 2: pHjust after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 2: PaCO2just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 2: CO2just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 3: FCjust after pneumoperitoneum exsufflation - patient lying flatThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 3: PAMjust after pneumoperitoneum exsufflation - patient lying flatThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 3: pHjust after pneumoperitoneum exsufflation - patient lying flatThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - moment 3: CO2just after pneumoperitoneum exsufflation - patient lying flatThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 3: PaCO2just after pneumoperitoneum exsufflation - patient lying flatThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - if recruitment manoeuvers occurs: FCFive minutes after any recruitment manoeuverThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - if recruitment manoeuvers occurs: PAMFive minutes after any recruitment manoeuverThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - if recruitment manoeuvers occurs: SpO2Five minutes after any recruitment manoeuverThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - if recruitment manoeuvers occurs: pHFive minutes after any recruitment manoeuverThe hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type).
Operative physiologic measures - if recruitment manoeuvers occurs: PaCO2Five minutes after any recruitment manoeuverThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - if recruitment manoeuvers occurs: PaO2Five minutes after any recruitment manoeuverThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - if recruitment manoeuvers occurs: CO2Five minutes after any recruitment manoeuverThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Pre-operative physiologic measures: partial pressure of oxygen in the arterial blood (PaO2)Just before surgery, at ambient air contactThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 1: PaO2just after induction/intubation, patient laying flat, without pneumoperitoneumThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Number of recruitment manoeuversFrom 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%.
Operative physiologic measures - moment 3: PaO2just after pneumoperitoneum exsufflation - patient lying flatThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Pre-operative physiologic measures: Oxygen Pulsated Saturation (SpO2)Just before surgery, at ambient air contactThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 1: SpO2just after induction/intubation, patient laying flat, without pneumoperitoneumThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 2: SpO2just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 3: SpO2just after pneumoperitoneum exsufflation - patient lying flatThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Operative physiologic measures - moment 2: PaO2just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementationThe gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens)
Pulmonary dynamic compliance (Cd) - preoperativeJust before surgery, at ambient air contactThis will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026