Evaluation of the Effectiveness of Lung-Protective Ventilation in Patients Undergoing Laparoscopic Gastrectomy

NCT07823816 | Enrolling By Invitation

• 1 other identifier: 10240152
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if lung-protective ventilation can improve perioperative oxygenation and reduce postoperative pulmonary complications in patients undergoing elective laparoscopic gastrectomy. The main questions it aims to answer are:

• Does lung-protective ventilation improve intraoperative and postoperative gas exchange compared to conventional ventilation?
• What are the effects of this ventilation strategy on pulmonary mechanics, hemodynamic parameters, and the incidence of postoperative pulmonary complications? Researchers will compare lung-protective ventilation to conventional ventilation to see if the protective strategy safely mitigates atelectasis and improves oxygenation during surgery. Participants will:
• Receive either conventional ventilation or lung-protective ventilation (using lower tidal volumes with appropriate PEEP and recruitment maneuvers) while under general anesthesia for their surgery.
• Have their gas exchange, pulmonary mechanics, and hemodynamic parameters continuously monitored during and after the operation.
• Be assessed for any postoperative pulmonary complications following the surgery.

Conditions

Postoperative Pulmonary Complications (PPCs); Atelectasis

Keywords

Laparoscopic gastrectomy; Lung-protective ventilation; Positive end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

• Intraoperative and Postoperative Gas Exchange (PaO2/FiO2 Ratio)

  The ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2). This index is used to evaluate the efficiency of pulmonary gas exchange and oxygenation status. PaO2 values are obtained from arterial blood gas (ABG) analysis. A higher ratio indicates better oxygenation.

  Assessed at 4 specific time points: T1: Baseline (before induction of anesthesia). T2: 1 hour after the start of CO2 pneumoperitoneum. T3: 30 minutes after tracheal extubation. T4: Postoperative day 1 (approximately 24 hours after surgery).

Secondary Outcomes (11)

• Peak Inspiratory Pressure (Ppeak)

  Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).

• Driving Pressure (Pdriving)

  Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).

• Plateau Pressure (Pplat)

  Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).

• Dynamic Lung Compliance (Cdyn)

  Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).

• Static Lung Compliance (Cstat)

  Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).

Study Arms (2)

Conventional Ventilation

ACTIVE COMPARATOR

Procedure: Conventional Ventilation

Lung-Protective Ventilation

EXPERIMENTAL

Procedure: Lung-Protective Ventilation

Interventions

Conventional Ventilation PROCEDURE

Patients in this group will receive conventional intraoperative mechanical ventilation during surgery. The ventilator settings include a tidal volume (VT) of 8 ml/kg based on predicted body weight (PBW) and a positive end-expiratory pressure (PEEP) of 5 cmH2O.

Conventional Ventilation

Lung-Protective Ventilation PROCEDURE

Patients assigned to the lung-protective ventilation arm will receive a standardized intraoperative strategy using Volume-Controlled Ventilation (VCV) with a tidal volume of 6 ml/kg based on predicted body weight, a respiratory rate of 12 breaths per minute, an I:E ratio of 1:2, and an inspiratory pause greater than 0.2 seconds to minimize resistance for compliance calculations. Following an initial alveolar recruitment maneuver, a decremental PEEP titration will be performed by starting at 14 cmH2O and decreasing by 2 cmH2O every 4 minutes down to a minimum of 6 cmH2O to identify and maintain the optimal PEEP level, which is defined as the point of highest dynamic lung compliance. Furthermore, automated alveolar recruitment maneuvers applying a sustained pressure of 40 cmH2O for 15 seconds will be systematically executed immediately after endotracheal intubation, repeated every 30 minutes throughout the surgical procedure, and performed a final time immediately before extubation.

Lung-Protective Ventilation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years scheduled for elective laparoscopic gastrectomy with ananticipated operative time \> 3 hours.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Body mass index (BMI) \< 30 kg/m².

You may not qualify if:

• Gestational diabetes mellitus or pre-existing (chronic) diabetes mellitus
• Gestational hypertension or chronic hypertension
• Body mass index (BMI) ≥ 35 kg/m²
• Known allergy to dexamethasone
• Current long-term corticosteroid therapy
• Diagnosis of postpartum hemorrhage

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead
• Hanoi Medical University: collaborator

Study Sites (1)

University Medical Center HCMC

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, single-blind, parallel-group clinical trial

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: September 16, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-05

Locations

VN (1)