NCT01726140

CPAP Reduces Hypoxemia After Cardiac Surgery

CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS Trial). A Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Failure Requiring Reintubation

Interventions

Type	Name	Description
PROCEDURE	Helmet CPAP	the patient will receive CPAP treatment, at a PEEP level of 10 cmH2O and a FiO2 adjusted to maintain SpO2\>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will repeat a spontaneous breathing trial with a Venturi mask at FiO2 = 50%, for 15 minutes and than a blood gas analysis will be repeated: if the PaO2/FiO2 will be \< 200 the patient will received a second treatment with CPAP; if PaO2/FiO2 will be \>200, the patient will stop the treatment.
PROCEDURE	Venturi Mask	the patient will maintain spontaneous breathing, with a system for oxygen delivery at a FiO2 adjusted to maintain SpO2\>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will do a trial for 15 minutes and after that a blood gas analysis will be repeated: if the PaO2/FiO2 will be \< 200 the patient will go on with the control treatment; if PaO2 /FiO2 will be \>200, the patient will stop the treatment.

Timeline

• Start date: 2013-04-01
• Primary completion: 2023-07-01
• Completion: 2024-01-01
• First posted: 2012-11-14
• Last updated: 2025-03-17

Locations

1 site across 1 country: Italy