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

Institut Cancerologie de l'Ouest

Status: Completed

Conditions: Surgical Patients; Pulmonary Complication

Treatments: Procedure: postoperative standard care; Procedure: Prophylactic non-invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03629431

ICO-A-2016-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

266 participants in 2 patient groups

postoperative standard care

Active Comparator group

Description:

Standard care after surgery in postoperative unit

Treatment:

Procedure: postoperative standard care

Prophylactic non-invasive ventilation

Experimental group

Description:

Prophylactic noninvasive ventilation in postoperative and intensive care unit

Treatment:

Procedure: Prophylactic non-invasive ventilation