CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Turin, Italy
Sponsor:
Information provided by (Responsible Party):
Daniela Pasero, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01726140
First received: November 6, 2012
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Failure Requiring Reintubation
Procedure: Helmet CPAP
Procedure: Venturi Mask
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS Trial). A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • rate of re-intubation [ Time Frame: at 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of atelectasis [ Time Frame: at 28 days ] [ Designated as safety issue: No ]
  • incidence of pneumonia [ Time Frame: at 28 days ] [ Designated as safety issue: No ]
  • incidence of sepsis [ Time Frame: at 28 days ] [ Designated as safety issue: No ]
  • mortality rate [ Time Frame: at 28 days ] [ Designated as safety issue: No ]
  • the intensive care unit length of stay [ Time Frame: at 28 days ] [ Designated as safety issue: No ]
  • hospital length of stay [ Time Frame: at 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 960
Study Start Date: April 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TREATMENT
Helmet CPAP
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
Venturi Mask
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726140

Contacts
Contact: Daniela Pasero, MD +390116336129 daniela.pasero@unito.it
Contact: Claudia Filippini, PhD +390116336140 claudia.filippini@unito.it

Locations
Italy
University of Turin - Department of Anesthesia and Intensive Care Medicine Recruiting
Turin, Italy, 10126
Contact: Daniela Pasero, MD    +390116336129    daniela.pasero@unito.it   
Sponsors and Collaborators
University of Turin, Italy
Investigators
Study Chair: Vito Marco VM Ranieri, MD University of Turin
  More Information

No publications provided

Responsible Party: Daniela Pasero, Principal Investigator, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01726140     History of Changes
Other Study ID Numbers: CRHACS CEI-457
Study First Received: November 6, 2012
Last Updated: May 30, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
intubation
respiratory failure
cardiac surgery

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on July 23, 2014