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

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

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 Overview

• Status: Unknown
• Conditions: Pulmonary Complication; Surgical Patients
• Intervention / Treatment: Procedure: postoperative standard care; Procedure: Prophylactic non-invasive ventilation

Detailed Description

After verification of eligibility criteria and ARISCAT score, patients at high risk of COPD are randomized in the study.

At the exit of the operating room, patients are referred to the services according to their randomization arm :

• arm with prophylactic noninvasive ventilation in intensive care unit. Patients will receive noninvasive ventilation for a maximum of 48 hours. Sessions last 1 hour and are repeated every 2 to 3 hours
• arm with standard care in conventional care unit. Patients receive standard care such as physiotherapy.

In both arms, patient follow-up is 7 days maximum.

• Study Type: Interventional
• Enrollment (Anticipated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MARINE TIGREAT; Phone Number: 2821 +33 241352700; Email: marine.tigreat@ico.unicancer.fr

Study Locations

• France
  • Angers, France, 49000
    • Recruiting
    • Institut de Cancérologie de l'Ouest
  • Angers, France, 49000
    • Recruiting
    • CHU d'Angers
    • Contact: Cyril SARGENTINI, MD; Phone Number: 0241353951; Email: cysargentini@chu-angers.fr
  • Le Mans, France, 72037
    • Recruiting
    • CH du Mans
    • Contact: Sigrid Caron, MD; Phone Number: 0243434343; Email: scaron@ch-lemans.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: postoperative standard care; Standard care after surgery in postoperative unit	Procedure: postoperative standard care; Standard care received postoperatively
EXPERIMENTAL: Prophylactic non-invasive ventilation; Prophylactic noninvasive ventilation in postoperative and intensive care unit	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the efficiency of a standard care to a preventative postoperative care strategy by noninvasive ventilation	The occurrence of an acute respiratory failure within the 7 days after surgery in intra-hospital validated by the adjudication comity, randomized, single-blind trial.	19 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Security and innocuousness of the study strategy	All adverse events due to study strategy	19 months
Mortality during hospitalization for surgery	Death whatever the cause during hospitalization for surgery (maximum 7 days)	19 months
An effect on the reintubation of patients	Reason and elay of reintubation	19 months
An effect on duration of stay in ongoing monitoring unit/reanimation and on invasive or not mechanical ventilation	The number of days of invasive mechanical ventilation, or non-invasive mechanical ventilation,	19 months

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Collaborators: Direction Générale de l'Offre de Soins
• Investigators: Principal Investigator: DENIS DUPOIRON, MD, Institut de Cancérologie de l'Ouest

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2017
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (ACTUAL): August 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: complications; postoperative; ARISCAT
• Other Study ID Numbers: ICO-A-2016-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No