N/A
N=266
Prophylactic Noninvasive Ventilation in vs Postoperative Standard Care in High Risk Patients According to ARISCAT Score
Surgical Patients · Pulmonary Complication
Bottom Line
View on ClinicalTrials.gov: NCT03629431 ↗Enrolled (actual)
266
Serious AEs
13.4%
Results posted
Jan 2026
Primary outcome: Primary: Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First) — 35; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prophylactic non-invasive ventilation (Procedure); postoperative standard care (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Cancerologie de l'Ouest
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First) |
35; 30 | — |
| SECONDARY Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) |
41; 36; 0; 3; 73; 61 | — |
| SECONDARY Reintubation Rate Within 7 Days |
8; 9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03629431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.