NCT03629431

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Patients
• Pulmonary Complication

Interventions

Type	Name	Description
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.
PROCEDURE	postoperative standard care	Standard care received postoperatively

Timeline

• Start date: 2017-11-03
• Primary completion: 2019-10-16
• Completion: 2019-10-16
• First posted: 2018-08-14
• Last updated: 2026-01-27
• Results posted: 2026-01-27

Locations

3 sites across 1 country: France