18 and older, any sex, with Surgical Patients or Pulmonary Complication. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First)Primary· Up to 7 days post-surgery or until hospital discharge (study duration: 23 months)
The outcome was reported as the count of participants who experienced acute respiratory failure, defined as the need for invasive or non-invasive mechanical ventilation within 7 days after surgery or until hospital discharge, whichever occurred first. All events were validated by an adjudication committee in this randomized, single-blind trial.
Group
Value
95% CI
Postoperative Standard Care
35
Prophylactic Non-invasive Ventilation
30
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria)Secondary· 30days
The outcome was reported as the count of participants who developed healthcare-associated infections within 30 days after surgery, defined according to the Centers for Disease Control and Prevention (CDC) criteria. All events were validated by an adjudication committee
Pleural effusion
Group
Value
95% CI
Postoperative Standard Care
41
Prophylactic Non-invasive Ventilation
36
Bronchospasm
Group
Value
95% CI
Postoperative Standard Care
0
Prophylactic Non-invasive Ventilation
3
Atelectasis
Group
Value
95% CI
Postoperative Standard Care
73
Prophylactic Non-invasive Ventilation
61
Upper airways obstruction
Group
Value
95% CI
Postoperative Standard Care
10
Prophylactic Non-invasive Ventilation
4
Pulmonary edema
Group
Value
95% CI
Postoperative Standard Care
15
Prophylactic Non-invasive Ventilation
11
Aspiration pneumonitis
Group
Value
95% CI
Postoperative Standard Care
1
Prophylactic Non-invasive Ventilation
2
Respiratory infection
Group
Value
95% CI
Postoperative Standard Care
3
Prophylactic Non-invasive Ventilation
3
Pneumothorax
Group
Value
95% CI
Postoperative Standard Care
4
Prophylactic Non-invasive Ventilation
6
Reintubation Rate Within 7 DaysSecondary· 7 days
Number of patients reintubated
Group
Value
95% CI
Postoperative Standard Care
8
Prophylactic Non-invasive Ventilation
9
Adverse events — posted to ClinicalTrials.gov
Time frame: From signature of consent to the end of follow up (30 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07348497 — Effects of Preoperative Education on Anxiety and Emergence Agitation
· NA
· active not recruiting
NCT04155346 — Prehab for Surgery
· NA
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institut Cancerologie de l'Ouest
Last refreshed: 27 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03629431.