CPAP Reduces Hypoxemia After Cardiac Surgery

Acute Respiratory Failure Requiring Reintubation Clinical Trial

— CRHACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01726140
• Other study ID #: CRHACS CEI-457
• Status: Recruiting
• Phase: N/A
• First received: November 6, 2012
• Last updated: July 10, 2017
• Start date: April 2013
• Est. completion date: November 2017

Study information

• Verified date: July 2017
• Source: University of Turin, Italy
• Contact: Daniela Pasero, MD
• Phone: +390116336129
• Email: daniela.pasero[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure Requiring Reintubation
• Anoxia
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	University of Turin - Department of Anesthesia and Intensive Care Medicine	Turin

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Agenzia Italiana del Farmaco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of re-intubation		at 28 days
Secondary	incidence of atelectasis		at 28 days
Secondary	incidence of pneumonia		at 28 days
Secondary	incidence of sepsis		at 28 days
Secondary	mortality rate		at 28 days
Secondary	the intensive care unit length of stay		at 28 days
Secondary	hospital length of stay		at 28 days