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

NCT03629431 | Completed Results DMC

• 1 other identifier: ICO-A-2016-04
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

ARISCAT; complications; postoperative

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First)

  The outcome was reported as the count of participants who experienced acute respiratory failure, defined as the need for invasive or non-invasive mechanical ventilation within 7 days after surgery or until hospital discharge, whichever occurred first. All events were validated by an adjudication committee in this randomized, single-blind trial.

  Up to 7 days post-surgery or until hospital discharge (study duration: 23 months)

Secondary Outcomes (2)

• Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria)

  30days

• Reintubation Rate Within 7 Days

  7 days

Study Arms (2)

postoperative standard care

ACTIVE COMPARATOR

Standard care after surgery in postoperative unit

Procedure: postoperative standard care

Prophylactic non-invasive ventilation

EXPERIMENTAL

Prophylactic noninvasive ventilation in postoperative and intensive care unit

Procedure: Prophylactic non-invasive ventilation

Interventions

Prophylactic non-invasive ventilation PROCEDURE

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.

Prophylactic non-invasive ventilation

postoperative standard care PROCEDURE

Standard care received postoperatively

postoperative standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 18 years of age or older
• Patient scheduled for surgery or considered semi-urgent (=pre-anesthesia consultation \<48h before the surgical procedure) under General Anesthesia or under Loco-Regional Anesthesia
• Patient with an ARISCAT score higher than or equal to 45 - Obtaining the signed written consent of the patient
• Patient affiliated to a social security scheme

You may not qualify if:

• Minor patients, pregnant or lactating women
• Obstetrical interventions
• Surgery under Local Anesthesia or Peripheral Nerve,
• Interventions taking place outside an interventional room
• Interventions for previous surgical complications
• Second surgery during study
• Organ transplantation
• Patients already intubated in preoperative
• Outpatient surgery
• Refusal of participation or inability to issue informed consent
• Person deprived of liberty or adult under guardianship
• Participation in another interventional study

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (3)

Chu D'Angers

Angers, 49000, France

Location

Institut de Cancerologie de L'Ouest

Angers, 49000, France

Location

Ch Du Mans

Le Mans, 72037, France

Location

Related Publications (1)

• Abrard S, Rineau E, Seegers V, Lebrec N, Sargentini C, Jeanneteau A, Longeau E, Caron S, Callahan JC, Chudeau N, Beloncle F, Lasocki S, Dupoiron D. Postoperative prophylactic intermittent noninvasive ventilation versus usual postoperative care for patients at high risk of pulmonary complications: a multicentre randomised trial. Br J Anaesth. 2023 Jan;130(1):e160-e168. doi: 10.1016/j.bja.2021.11.033. Epub 2022 Jan 5.

  PMID: 34996593 DERIVED

Results Point of Contact

• Title: Dr Denis DUPOIRON
• Organization: INSTITUT DE CANCEROLOGIE DE L'OUEST

denis.dupoiron@ico.unicancer.fr

241352700

Study Officials

• DENIS DUPOIRON, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a study phase III, multicentre, comparative, randomized, controlled, superiority and open

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: August 14, 2018
• Study Start: November 3, 2017
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)