NCT07629102

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
Last Updated

June 5, 2026

Status Verified

May 1, 2026

Enrollment Period

14 days

First QC Date

May 22, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Obesitylaparoscopic sleeve gastrectomyPEEP titrationperioperative oxygenation

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2 ratio

    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 Outcomes (4)

  • Postoperative pulmonary function tests

    Were evaluated before the surgery and on the day of hospital discharge

  • Intensive care unit admission

    Postoperative day 0

  • PaCO₂, pH, oxygen saturation

    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

    On which day the patients were discharged

Study Arms (2)

PEEP 5/no recruitment maneuver

OTHER

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

Other: PEEP 5 cmH2O

PEEP 8/recruitment maneuver

OTHER

Patients received a protective ventilation strategy consisting of PEEP 8 cmH₂O combined with repeated recruitment maneuvers performed after pneumoperitoneum insufflation and before extubation

Other: PEEP 8 cmH2O + Recruitment Maneuvers

Interventions

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 8/recruitment maneuver

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

PEEP 5/no recruitment maneuver

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- American Society of Anesthesiologists (ASA) physical status I-III who underwent elective laparoscopic sleeve gastrectomy

You may not qualify if:

  • revision bariatric surgery
  • gastric bypass surgery
  • conversion to open surgery
  • incomplete perioperative records
  • missing arterial blood gas measurements
  • unavailable postoperative pulmonary function tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
The study was conducted retrospectively.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 5, 2026

Study Start

April 1, 2026

Primary Completion

April 15, 2026

Study Completion

May 20, 2026

Last Updated

June 5, 2026

Record last verified: 2026-05

Locations