CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS)
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|ClinicalTrials.gov Identifier: NCT01726140|
Recruitment Status : Recruiting
First Posted : November 14, 2012
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment|
|Acute Respiratory Failure Requiring Reintubation||Procedure: Helmet CPAP Procedure: Venturi Mask|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||960 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS Trial). A Randomized Controlled Trial|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||November 2017|
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.
Active Comparator: CONTROL
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.
- rate of re-intubation [ Time Frame: at 28 days ]
- incidence of atelectasis [ Time Frame: at 28 days ]
- incidence of pneumonia [ Time Frame: at 28 days ]
- incidence of sepsis [ Time Frame: at 28 days ]
- mortality rate [ Time Frame: at 28 days ]
- the intensive care unit length of stay [ Time Frame: at 28 days ]
- hospital length of stay [ Time Frame: at 28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726140
|Contact: Daniela Pasero, MDemail@example.com|
|Contact: Claudia Filippini, PhDfirstname.lastname@example.org|
|University of Turin - Department of Anesthesia and Intensive Care Medicine||Recruiting|
|Turin, Italy, 10126|
|Contact: Daniela Pasero, MD +390116336129 email@example.com|
|Study Chair:||Vito Marco VM Ranieri, MD||University of Turin, Italy|