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

Not Applicable

• Conditions: Surgical Patients; Pulmonary Complication
• Interventions: Procedure: postoperative standard care; Procedure: Prophylactic non-invasive ventilation

• Registration Number: NCT03629431
• Lead Sponsor: Institut Cancerologie de l'Ouest

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.

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 Timeline

• Study Start: 2017-10-20
• Status Verified: 2018-07
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-14
• Last Update Posted: 2018-08-14
• Primary Completion: 2019-05
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 266

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
postoperative standard care	postoperative standard care	Standard care after surgery in postoperative unit
Prophylactic non-invasive ventilation	Prophylactic non-invasive ventilation	Prophylactic noninvasive ventilation in postoperative and intensive care unit

Primary Outcome Measures

Name	Time	Method
To compare the efficiency of a standard care to a preventative postoperative care strategy by noninvasive ventilation	19 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Ch Du Mans; 🇫🇷 Le Mans, France

Institut de Cancerologie de L'Ouest; 🇫🇷 Angers, France

Chu D'Angers; 🇫🇷 Angers, France