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

Pulmonary Complication Clinical Trial

— ANTICIPUSC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03629431
• Other study ID #: ICO-A-2016-04
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: June 2019

Study information

• Verified date: July 2018
• Source: Institut Cancerologie de l'Ouest
• Contact: DENIS DUPOIRON, MD
• Phone: +33 241352700
• Email: denis.dupoiron[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Complication
• Surgical Patients

Intervention

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.
• postoperative standard care
Standard care received postoperatively

Locations

Country	Name	City	State
France	Chu D'Angers	Angers
France	Institut de Cancerologie de L'Ouest	Angers
France	Ch Du Mans	Le Mans

Sponsors (2)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest	Direction Générale de l'Offre de Soins

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Security and innocuousness of the study strategy	All adverse events due to study strategy	19 months
Secondary	Mortality during hospitalization for surgery	Death whatever the cause during hospitalization for surgery (maximum 7 days)	19 months
Secondary	An effect on the reintubation of patients	Reason and elay of reintubation	19 months
Secondary	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