CPAP Reduces Hypoxemia After Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Respiratory Failure Requiring Reintubation

Intervention / Treatment
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* Procedure: Helmet CPAP
* Procedure: Venturi Mask


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TREATMENT<br>Helmet CPAP | Procedure: Helmet CPAP<br>* 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.<br>|
| Active Comparator: CONTROL<br>Venturi Mask | Procedure: Venturi Mask<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of re-intubation |  | at 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of atelectasis |  | at 28 days | 
| incidence of pneumonia |  | at 28 days | 
| incidence of sepsis |  | at 28 days | 
| mortality rate |  | at 28 days | 
| the intensive care unit length of stay |  | at 28 days | 
| hospital length of stay |  | at 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, respiratory failure, cardiac surgery