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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgical Patients, Pulmonary Complication

Intervention / Treatment
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* Procedure: Prophylactic non-invasive ventilation
* Procedure: postoperative standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a study phase III, multicentre, comparative, randomized, controlled, superiority and open
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: postoperative standard care<br>Standard care after surgery in postoperative unit | Procedure: postoperative standard care<br>* Standard care received postoperatively<br>|
| Experimental: Prophylactic non-invasive ventilation<br>Prophylactic noninvasive ventilation in postoperative and intensive care unit | Procedure: Prophylactic non-invasive ventilation<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARISCAT, complications, postoperative