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Prophylactic Noninvasive Ventilation in vs Postoperative Standard Care in High Risk Patients According to ARISCAT Score

NCT03629431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-01-27

Study results available
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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.

Conditions

  • Surgical Patients
  • Pulmonary Complication

Interventions

PROCEDURE

Prophylactic non-invasive ventilation

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.

PROCEDURE

postoperative standard care

Standard care received postoperatively

Sponsors & Collaborators

  • Direction Générale de l'Offre de Soins

    collaborator OTHER_GOV

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • DENIS DUPOIRON, MD · Institut de Cancérologie de l'Ouest

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2019-10-16
Completion
2019-10-16

Countries

  • France

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 NCT03629431 on ClinicalTrials.gov