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||Phase|
|Acute Respiratory Failure Requiring Reintubation||Procedure: Helmet CPAP Procedure: Venturi Mask||Not Applicable|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726140
|Contact: Daniela Pasero, MDfirstname.lastname@example.org|
|Contact: Claudia Filippini, PhDemail@example.com|
|University of Turin - Department of Anesthesia and Intensive Care Medicine||Recruiting|
|Turin, Italy, 10126|
|Contact: Daniela Pasero, MD +390116336129 firstname.lastname@example.org|
|Study Chair:||Vito Marco VM Ranieri, MD||University of Turin, Italy|