Prophylactic Noninvasive Ventilation in vs Postoperative Standard Care in High Risk Patients Acco… (NCT03629431) | Clinical Trial Compass
CompletedNot Applicable
Prophylactic Noninvasive Ventilation in vs Postoperative Standard Care in High Risk Patients According to ARISCAT Score
France266 participantsStarted 2017-11-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First)
Timeframe: Up to 7 days post-surgery or until hospital discharge (study duration: 23 months)