CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 266 enrolled
Drug / intervention
Prophylactic non-invasive ventilation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03629431
NCT03629431N/ACompleted

Multicenter, Randomized, Open Study, Assessing Prophylactic Noninvasive Ventilation in Intensive Care Unit vs Postoperative Standard Care for Patients With High Risk of Postoperative Pulmonary Complication With Preoperative ARISCAT Score

Institut Cancerologie de l'Ouest·interventional·Posted Aug 14, 2018·Updated Jan 27, 2026

In Brief

A clinical study evaluating Prophylactic non-invasive ventilation and postoperative standard care for Surgical Patients and Pulmonary Complication. Completed, enrolled 266 participants across 3 sites.

Detailed Summary

Postoperative pulmonary complications are one of the most common complications after surgery. Noninvasive ventilation has been proposed post-operatively to prevent postoperative pulmonary complications. Prophylactic noninvasive ventilation performed systematically in a non-specific population is without interest. The difficulty for the practitioner is to target patients at higher risk of developing a postoperative pulmonary complications in order to guiding them to a post-operative specialized care pathway. The use of the ARISCAT score, validated on a large European prospective cohort, makes it possible to evaluate, preoperatively, the risk of occurrence of postoperative pulmonary complication in the patient. The hypothesis of the present research is that early postoperative preventive treatment with noninvasive ventilation, in patients at risk of postoperative pulmonary complications according to the preoperative evaluation according to the ARISCAT score, could have an interest in reducing these complications with a superior efficiency over standard techniques.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartNov 3, 2017
Primary CompletionOct 16, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.9 years ago

Interventions

Prophylactic non-invasive ventilationprocedure

The sessions of NIV last 1 hour and are repeated every 2 to 3 hours with a goal of a daily assistance period of 6 to 8 hours for a minimum of 24 hours. The sessions are spaced by periods of unassisted ventilation of 2 hours allowing the patient to rest, feed, receive care including physiotherapy sessions.

postoperative standard careprocedure

Standard care received postoperatively