- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07629102
Perioperative Respiratory Function in Sleeve Gastrectomy
Perioperative Oxygenation and Respiratory Function in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Retrospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity is associated with substantial alterations in respiratory physiology, including reduced functional residual capacity, decreased respiratory compliance, impaired diaphragmatic excursion, and increased susceptibility to perioperative atelectasis and hypoxemia. These physiologic changes become more pronounced during general anesthesia and laparoscopic surgery because of positive-pressure ventilation and carbon dioxide pneumoperitoneum. Consequently, obese patients undergoing bariatric surgery represent a particularly vulnerable population for perioperative respiratory impairment.
Lung-protective ventilation strategies incorporating low tidal volume ventilation, positive end-expiratory pressure (PEEP), and recruitment maneuvers have been increasingly utilized in obese surgical patients to improve oxygenation and reduce atelectatic changes. However, despite improvements in intraoperative respiratory mechanics and oxygenation reported in previous studies, the clinical significance and incremental benefit of intensified ventilation strategies remain uncertain, particularly in contemporary bariatric anesthesia settings where protective ventilation principles are already routinely applied.
This retrospective single-center cohort study evaluates perioperative oxygenation and respiratory outcomes in obese patients undergoing elective laparoscopic sleeve gastrectomy between January 2021 and January 2026. All patients were managed using standardized anesthetic and surgical protocols, including volume-controlled ventilation with tidal volumes of 6-8 mL/kg ideal body weight and fixed inspired oxygen fraction (FiO₂ 45%).
Patients were divided into two groups according to intraoperative ventilation strategy. The first group received conventional ventilation with PEEP 5 cmH₂O without recruitment maneuvers. The second group received a protective ventilation strategy consisting of PEEP 8 cmH₂O combined with repeated recruitment maneuvers performed after pneumoperitoneum establishment and before extubation.
Perioperative oxygenation was assessed using serial PaO₂/FiO₂ measurements obtained immediately after endotracheal intubation (T0), 10 minutes after pneumoperitoneum establishment (T1), and 5 minutes after extubation (T2). Secondary outcomes included arterial blood gas variables, postoperative spirometric parameters, lactate levels, intensive care unit admission, and hospital length of stay.
The primary objective of the study is to determine whether escalation from conventional PEEP 5 cmH₂O ventilation to PEEP 8 cmH₂O combined with recruitment maneuvers provides incremental perioperative respiratory benefit in obese patients undergoing laparoscopic sleeve gastrectomy within a standardized contemporary bariatric anesthesia setting.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Basaksehir Cam and Sakura City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-III who underwent elective laparoscopic sleeve gastrectomy
Exclusion Criteria:
- revision bariatric surgery
- gastric bypass surgery
- conversion to open surgery
- incomplete perioperative records
- missing arterial blood gas measurements
- unavailable postoperative pulmonary function tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: PEEP 5/no recruitment maneuver
Patients were ventilated with a positive end-expiratory pressure (PEEP) of 5 cmH₂O without recruitment maneuvers
|
Patients were ventilated with a positive end-expiratory pressure (PEEP) of 5 cmH₂O without recruitment maneuvers
|
|
Other: PEEP 8/recruitment maneuver
Patients received a protective ventilation strategy consisting of PEEP 8 cmH₂O combined with repeated recruitment maneuvers performed after pneumoperitoneum insufflation and before extubation
|
Recruitment maneuvers were performed using a stepwise PEEP increase strategy.
PEEP levels were gradually increased over consecutive respiratory cycles up to 15-20 cmH₂O and subsequently reduced to the assigned maintenance PEEP level.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PaO2/FiO2 ratio
Time Frame: T0: immediately after endotracheal intubation • T1: 10 minutes after establishment of pneumoperitoneum and achievement of the target intra-abdominal pressure • T2: 5 minutes afte
|
The primary outcome of the study was perioperative oxygenation assessed by serial PaO2/FiO2 ratio measurements.
|
T0: immediately after endotracheal intubation • T1: 10 minutes after establishment of pneumoperitoneum and achievement of the target intra-abdominal pressure • T2: 5 minutes afte
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pulmonary function tests
Time Frame: Were evaluated before the surgery and on the day of hospital discharge
|
forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio
|
Were evaluated before the surgery and on the day of hospital discharge
|
|
Intensive care unit admission
Time Frame: Postoperative day 0
|
Patients requiring intensive care admission
|
Postoperative day 0
|
|
PaCO₂, pH, oxygen saturation
Time Frame: T0: immediately after endotracheal intubation • T1: 10 minutes after establishment of pneumoperitoneum and achievement of the target intra-abdominal pressure • T2: 5 minutes afte
|
Blood gas analyses parameters
|
T0: immediately after endotracheal intubation • T1: 10 minutes after establishment of pneumoperitoneum and achievement of the target intra-abdominal pressure • T2: 5 minutes afte
|
|
Hospital length of stay
Time Frame: On which day the patients were discharged
|
How many days did the patient stay in the hospital?
|
On which day the patients were discharged
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-134
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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