ANTICIPUSC: Preoperative anticipation of respiratory risk according to ARISCAT scoring system and prophylactic post-operative non-invasive ventilation, comparing to standard post-operative care in patients at high-risk of respiratory complications

Multicentric, comparative, randomized, open study comparing an early post-operative prophylactic non-invasive ventilation (NIV) to standard post-operative care in patients at high-risk of respiratory complications according to ARISCAT preoperative scoring system whose surgery is performed under general or loco-regional anesthesia (ANTICIPUSC).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001011-36-FR

Enrollment

266

Registered

2017-03-28

Start date

2017-05-24

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Legally adult patient going to have an operation under loco-regional or general anesthesia. MedDRA version: 19.1 Level: PT Classification code 10072651 Term: Postoperative respiratory failure System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: OXYGENE MEDICINAL LIQUIDE Product Name: OXYGEN Pharmaceutical Form: Medicinal gas, liquefied INN or Proposed INN: OXYGEN Oth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 86 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Secondary Objective: ;Primary end point(s): ;Timepoint(s) of evaluation of this end point: 7 post-operative days, intra-hospital; Main Objective: To compare the efficacy of a preventive non-invasive ventilation to standard care On the incidence of postoperative pulmonary complications of acute respiratory failure type, within 7 days post-operative in intra-hospital, in patients at high risk according to ARISCAT scoring system.	—

Measure

Time frame

Secondary Objective: ;Primary end point(s): ;Timepoint(s) of evaluation of this end point: 7 post-operative days, intra-hospital; Main Objective: To compare the efficacy of a preventive non-invasive ventilation to standard care On the incidence of postoperative pulmonary complications of acute respiratory failure type, within 7 days post-operative in intra-hospital, in patients at high risk according to ARISCAT scoring system.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 7 post-operative days, intra-hospital	—

Countries

France

Contacts

Public ContactDRCI

INSTITUT DE CANCEROLOGIE DE L'OUEST

marie-helene.mauboussin@ico.unicancer.fr33240 67 97 47

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 19, 2026