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CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS)

This study is currently recruiting participants.
Verified April 2013 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: April 29, 2013
Last verified: April 2013
History of Changes
  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
Respiratory Failure Needing Orotracheal Intubation
 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:

U.S. FDA Resources

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
the patient will receive CPAP treatment with Helmet (StarMed S.r.l.), 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: Helmet CPAP
Active Comparator: CONTROL
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.
 Procedure: Venturi Mask

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
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: April 29, 2013
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013