Clinical trial NCT03629431: Prophylactic Noninvasive Ventilation in vs Postoperative Standard Care in High Risk Patients According to ARISCAT Score
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Patients
Pulmonary Complication
Keywords: ARISCAT
complications
postoperative
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2018-08-14
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a study phase III, multicentre, comparative, randomized, controlled, superiority and open
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the efficiency of a standard care to a preventative postoperative care strategy by noninvasive ventilation
timeFrame: 19 months
Secondary outcomes:
measure: Security and innocuousness of the study strategy
timeFrame: 19 months
measure: Mortality during hospitalization for surgery
timeFrame: 19 months
measure: An effect on the reintubation of patients
timeFrame: 19 months
measure: An effect on duration of stay in ongoing monitoring unit/reanimation and on invasive or not mechanical ventilation
timeFrame: 19 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu D'Angers
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest
city: Le Mans
country: France
facility: Ch Du Mans
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: DENIS DUPOIRON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.