CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Respiratory Failure Requiring Reintubation
• Intervention / Treatment: Procedure: Helmet CPAP; 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.

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • University of Turin - Department of Anesthesia and Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of re-intubation	at 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality rate	at 28 days
incidence of atelectasis	at 28 days
incidence of pneumonia	at 28 days
incidence of sepsis	at 28 days
the intensive care unit length of stay	at 28 days
hospital length of stay	at 28 days

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Collaborators: Agenzia Italiana del Farmaco
• Investigators: Study Chair: Vito Marco VM Ranieri, MD, University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: November 8, 2012
• First Posted (Estimated): November 14, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; respiratory failure; intubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia
• Other Study ID Numbers: CRHACS CEI-457

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No