CPAP improves oxigenation after cardiac surgery

Phase 1

• Conditions: Hypoxemia after cardiac surgery; MedDRA version: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002672-13-IT
• Lead Sponsor: ALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

- patients undergoing cardiac surgery on cardiopulmonary bypass
- PaO2/FiO2 < 200 after extubation
- extubation time < 24 h.
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 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 320

Exclusion Criteria

- patients < 18 years old
- extracorporeal membrane oxygenation
- severe cardiac dysfunction (FE<25%)
- mechanical ventilation before the intervention
- severe COPD (patients on oxygen therapy, with a FEV1< 50%)
- heart or lung transplantation
- lack of consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified