CPAP Reduces Hypoxemia After Cardiac Surgery

Not Applicable

Terminated

• Conditions: Acute Respiratory Failure Requiring Reintubation
• Interventions: Procedure: Venturi Mask; Procedure: Helmet CPAP

• Registration Number: NCT01726140
• Lead Sponsor: University of Turin, Italy

Brief Summary

The aim of study is to evaluate whether the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.

Detailed Description

We want to test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.

Primary end point: to reduce the rate of re-intubation.

Secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (ICU) and hospital length of stay.

Study Timeline

• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-14
• Study Start: 2013-04
• Primary Completion: 2023-07
• Study Completion: 2024-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 407

Inclusion Criteria

• patients undergoing cardiac surgery on cardiopulmonary bypass
• PaO2 /FiO2 < 200 after extubation
• extubation time < 24 h.

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
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL	Venturi Mask	Venturi Mask
TREATMENT	Helmet CPAP	Helmet CPAP

Primary Outcome Measures

Name	Time	Method
rate of re-intubation	at 28 days

Secondary Outcome Measures

Name	Time	Method
incidence of atelectasis	at 28 days
incidence of pneumonia	at 28 days
incidence of sepsis	at 28 days
the intensive care unit length of stay	at 28 days
mortality rate	at 28 days
hospital length of stay	at 28 days

Trial Locations

Locations (1)

University of Turin - Department of Anesthesia and Intensive Care Medicine; 🇮🇹 Turin, Italy