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Lung-protective Mechanical Ventilation for Abdominal Laparoscopic Surgeries

NCT04546932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-09-14

No results posted yet for this study

Summary

This was a double-blind, randomized controlled clinical trial. 62 patients were randomly assigned to receive either lung-protective ventilation (LPV) with a tidal volume (Vt) of 7 ml/kg ideal body weight (IBW), 10 cmH2O positive end-expiratory pressure (PEEP) combined with regular recruitment maneuvers or conventional ventilation (CV) with a Vt of 10 ml/kg IBW, 0 cmH2O in PEEP and no recruitment maneuvers. The primary endpoints were the intraoperative fluctuation of Cdyn and Cstat, the intra- and postoperative changes in pulmonary oxygenation function including OI, A-aO2. The secondary endpoints were the alteration on chest x-ray, modified Clinical Pulmonary Infection Score (mCPIS), and the incidence of PPCs on the first postoperative day

Conditions

  • Mechanical Ventilation Complication

Interventions

PROCEDURE

Lung-protective mechanical ventilation

Patients were provided with a tidal volume of 7 ml/kg IBW and an intraoperative 10 cmH2O in PEEP. Simultaneously, the alveoli were recruited applying a stepwise increase in PEEP (from 4 to 10 cmH2O for 3 breaths, 10 to 15 cmH2O for 3 breaths, and 15 to 20 cmH2O for 10 breaths) with maximum PIP = 50 cmH2O \[24\]. The recruitment maneuvers were performed right after intubation, 30 minutes after CO2 insufflation, then every hour, and finally before extubation.

Sponsors & Collaborators

  • Vietnam National Cancer Hospital

    collaborator INDIV

  • Vietnam Military Medical University

    lead OTHER

Principal Investigators

  • Kien T Nguyen, PhD · Critical Care Medicine and ClinicalToxicology, Military Hospital 103

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2020-06-24
Completion
2020-06-24

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546932 on ClinicalTrials.gov