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NCT Number: NCT07629102

Perioperative Respiratory Function in Sleeve Gastrectomy

This retrospective single-center cohort study aims to evaluate the effects of two intraoperative ventilation strategies on perioperative oxygenation and respiratory outcomes in obese patients undergoing laparoscopic sleeve gastrectomy. Patients were managed using standardized anesthetic and ventilatory protocols with volume-controlled ventilation and fixed inspired oxygen fraction (FiO₂ 45%). The study compares conventional ventilation with PEEP 5 cmH₂O versus a protective ventilation strategy consisting of PEEP 8 cmH₂O combined with repeated recruitment maneuvers performed after pneumoperitoneum establishment and before extubation. Perioperative oxygenation is assessed using serial PaO₂/FiO₂ measurements obtained immediately after intubation, after pneumoperitoneum establishment, and after extubation. Secondary outcomes include perioperative arterial blood gas variables, postoperative spirometric parameters, lactate levels, ICU admission, and hospital length of stay. The study aims to determine whether escalation of intraoperative ventilatory support provides incremental respiratory benefit in contemporary bariatric anesthesia practice.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP 8 cmH2O + Recruitment Maneuvers

Other

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.

PEEP 5 cmH2O

Other

Patients were ventilated with a positive end-expiratory pressure (PEEP) of 5 cmH₂O without recruitment maneuvers

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Intensive care unit admission

    Time frame: Postoperative day 0

    Patients requiring intensive care admission

  3. 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

  4. Hospital length of stay

    Time frame: On which day the patients were discharged

    How many days did the patient stay in the hospital?

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Registry information

Official study title

Perioperative Oxygenation and Respiratory Function in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Retrospective Cohort Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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