CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS)

University of Turin

Status: Terminated

Conditions: Acute Respiratory Failure Requiring Reintubation

Treatments: Procedure: Venturi Mask; Procedure: Helmet CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01726140

CRHACS CEI-457

Details and patient eligibility

About

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.

Full 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.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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407 participants in 2 patient groups

TREATMENT

Experimental group

Description:

Helmet CPAP

Treatment:

Procedure: Helmet CPAP

CONTROL

Active Comparator group

Description:

Venturi Mask

Treatment:

Procedure: Venturi Mask