Postoperative Pulmonary Complications (PPCs)NCT07823816

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

A study testing Conventional Ventilation and Lung-Protective Ventilation in people with Postoperative Pulmonary Complications (PPCs) and Atelectasis, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Postoperative Pulmonary Complications (PPCs), Atelectasis
What is being tested?: Conventional Ventilation and Lung-Protective Ventilation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteVietnam
Study dates: 1 Dec 2025to 31 Dec 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vietnam1 site

University Medical Center HCMC
Ho Chi Minh City, Ho Chi Minh, 700000

Other trials in Vietnam

About this study

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
Being tested: Conventional Ventilation, Lung-Protective Ventilation
Keywords: Laparoscopic gastrectomy, Lung-protective ventilation, Positive end-expiratory pressure
Medical subject headings: Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conventional VentilationProcedure or surgery
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.
Lung-Protective VentilationProcedure or surgery
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.

Study groups in NCT07823816
Study group	Role	What they receive
Conventional Ventilation	Active comparator	Not described Receives: Procedure: Conventional Ventilation
Lung-Protective Ventilation	Experimental	Not described Receives: Procedure: Lung-Protective Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
The study will evaluate pulmonary mechanics by measuring the peak inspiratory pressure (Ppeak).
Measured: 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)
The study will evaluate pulmonary mechanics by measuring the driving pressure (Pdriving).
Measured: 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)
The study will evaluate pulmonary mechanics by measuring the plateau pressure (Pplat).
Measured: 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)
The study will evaluate pulmonary mechanics by measuring the dynamic lung compliance (Cdyn).
Measured: 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)
The study will evaluate pulmonary mechanics by measuring the static lung compliance (Cstat).
Measured: Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).
Intraoperative Mean Arterial Pressure
Hemodynamic stability will be evaluated by measuring the mean arterial pressure (MAP).
Measured: Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).
Intraoperative Heart Rate
Hemodynamic stability will be evaluated by measuring the heart rate.
Measured: Assessed intraoperatively (recorded at post-intubation, 30 minutes after CO2 insufflation, every hour during CO2 insufflation, 10 minutes after CO2 exsufflation, and before extubation).
Incidence of Intraoperative Hypotension and Vasopressor Use
The study will record the number of participants experiencing intraoperative hypotension, defined as mean arterial pressure < 65 mmHg or systolic blood pressure < 90 mmHg, and the number of participants requiring vasopressors (ephedrine or phenylephrine).
Measured: During the anesthesia and surgical procedure.
Incidence of Postoperative Pulmonary Complications
The study will record the number of participants experiencing specific postoperative pulmonary complications, including atelectasis, pneumothorax, pneumonia, and acute respiratory distress syndrome (ARDS).
Measured: Atelectasis and pneumothorax assessed on postoperative day 1; pneumonia and ARDS assessed within 7 days after surgery.
Incidence of Intensive Care Unit (ICU) Admission
The study will record the number of participants requiring transfer to the intensive care unit from the post-anesthesia care unit due to respiratory complications.
Measured: Up to 7 days postoperatively
Length of Hospital Stay
The study will evaluate the length of hospital stay, calculated from the date of surgery to the date of hospital discharge.
Measured: From the date of surgery until hospital discharge, assessed up to 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202531 Dec 2026

First posted16 Sep 2026
Study start1 Dec 2025
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Postoperative Pulmonary Complications (PPCs)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, randomized, controlled, single-blind, parallel-group clinical trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 102 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07823816
Sponsor's protocol ID: 10240152
Status last verified: May 2026
First submitted: 22 May 2026
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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