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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ARISCAT, ASA and LAS VEGAS Risk Scores and the Incidence of Postoperative Pulmonary Complications in Thoracic Surgery

NCT06404892

Postoperative Complications

RECRUITING

Protective Ventilation Strategy

NCT03234621

One-lung Ventilation

COMPLETED NA

Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery

NCT02804997

Thoracic Surgery

TERMINATED

Noninvasive Ventilation Bundle in Postoperative Respiratory Failure

NCT02214368

Respiratory Insufficiency

COMPLETED NA

Non Invasive Ventilation in Abdominal Postoperative Period

NCT01971892

Surgery Trauma to the Abdomen Acute Respiratory Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Patients Pulmonary Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a study phase III, multicentre, comparative, randomized, controlled, superiority and open

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

postoperative standard care

Standard care after surgery in postoperative unit

Group Type ACTIVE_COMPARATOR

postoperative standard care

Intervention Type PROCEDURE

Standard care received postoperatively

Prophylactic non-invasive ventilation

Prophylactic noninvasive ventilation in postoperative and intensive care unit

Group Type EXPERIMENTAL

Prophylactic non-invasive ventilation

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

postoperative standard care

Standard care received postoperatively

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No