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Enrolling by invitationNCT07823816Updated Sep 16, 2026

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

An interventional study of Conventional Ventilation and Lung-Protective Ventilation in Postoperative Pulmonary Complications (PPCs) and Atelectasis, sponsored by University Medical Center Ho Chi Minh City (UMC). Enrolling by invitation at 1 site in Vietnam. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by University Medical Center Ho Chi Minh City (UMC) · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2025, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Postoperative Pulmonary Complications (PPCs)
  • Atelectasis

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Keywords

  • Laparoscopic gastrectomy
  • Lung-protective ventilation
  • Positive end-expiratory pressure
03

In context

Pulmonary Atelectasis

377 studies on the registry are indexed under Pulmonary Atelectasis; 93 are open to participants now.

This study's planned enrollment of 102 is above the median of 60 across 268 interventional studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

University Medical Center Ho Chi Minh City (UMC) is the lead sponsor of 34 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Gestational diabetes mellitus or pre-existing (chronic) diabetes mellitus
  • Gestational hypertension or chronic hypertension
  • (BMI) ≥ 35 kg/m²
  • Known allergy to dexamethasone
  • Current long-term therapy
  • Diagnosis of postpartum hemorrhage
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Active comparator
    Conventional Ventilation

    Procedure: Conventional Ventilation

  • Experimental
    Lung-Protective Ventilation

    Procedure: Lung-Protective Ventilation

Interventions

  • ProcedureConventional Ventilation

    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.

  • ProcedureLung-Protective Ventilation

    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.

06

What researchers measure

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.

    Time frame: 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

  1. Peak Inspiratory Pressure (Ppeak)

    The study will evaluate pulmonary mechanics by measuring the peak inspiratory pressure (Ppeak).

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

  2. Driving Pressure (Pdriving)

    The study will evaluate pulmonary mechanics by measuring the driving pressure (Pdriving).

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

  3. Plateau Pressure (Pplat)

    The study will evaluate pulmonary mechanics by measuring the plateau pressure (Pplat).

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

  4. Dynamic Lung Compliance (Cdyn)

    The study will evaluate pulmonary mechanics by measuring the dynamic lung compliance (Cdyn).

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

  5. Static Lung Compliance (Cstat)

    The study will evaluate pulmonary mechanics by measuring the static lung compliance (Cstat).

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

  6. Intraoperative Mean Arterial Pressure

    Hemodynamic stability will be evaluated by measuring the mean arterial pressure (MAP).

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

  7. Intraoperative Heart Rate

    Hemodynamic stability will be evaluated by measuring the heart rate.

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

  8. 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).

    Time frame: During the anesthesia and surgical procedure.

  9. 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).

    Time frame: Atelectasis and pneumothorax assessed on postoperative day 1; pneumonia and ARDS assessed within 7 days after surgery.

  10. 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.

    Time frame: Up to 7 days postoperatively

  11. 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.

    Time frame: From the date of surgery until hospital discharge, assessed up to 30 days.

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07823816
Lead sponsor
University Medical Center Ho Chi Minh City (UMC)
Collaborators
Hanoi Medical University
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Dec 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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