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CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS)

Primary Purpose

Acute Respiratory Failure Requiring Reintubation

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Helmet CPAP

Venturi Mask

About this trial

This is an interventional prevention trial for Acute Respiratory Failure Requiring Reintubation focused on measuring intubation, respiratory failure, cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Turin - Department of Anesthesia and Intensive Care MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TREATMENT

CONTROL

Arm Description

Helmet CPAP

Venturi Mask

Outcomes

Primary Outcome Measures

rate of re-intubation

Secondary Outcome Measures

incidence of atelectasis

incidence of pneumonia

incidence of sepsis

mortality rate

the intensive care unit length of stay

hospital length of stay

Full Information

NCT ID

NCT01726140

First Posted

November 6, 2012

Last Updated

July 10, 2017

Sponsor

University of Turin, Italy

Collaborators

Agenzia Italiana del Farmaco

1. Study Identification

Unique Protocol Identification Number

NCT01726140

Brief Title

CPAP Reduces Hypoxemia After Cardiac Surgery

Acronym

CRHACS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Turin, Italy

Collaborators

Agenzia Italiana del Farmaco

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Failure Requiring Reintubation

Keywords

intubation, respiratory failure, cardiac surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

960 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TREATMENT

Arm Type

Experimental

Arm Description

Helmet CPAP

Arm Title

CONTROL

Arm Type

Active Comparator

Arm Description

Venturi Mask

Intervention Type

Procedure

Intervention Name(s)

Helmet CPAP

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Venturi Mask

Intervention Description

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.

Primary Outcome Measure Information:

Title

rate of re-intubation

Time Frame

at 28 days

Secondary Outcome Measure Information:

Title

incidence of atelectasis

Time Frame

at 28 days

Title

incidence of pneumonia

Time Frame

at 28 days

Title

incidence of sepsis

Time Frame

at 28 days

Title

mortality rate

Time Frame

at 28 days

Title

the intensive care unit length of stay

Time Frame

at 28 days

Title

hospital length of stay

Time Frame

at 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniela Pasero, MD

Phone

+390116336129

daniela.pasero@unito.it

First Name & Middle Initial & Last Name or Official Title & Degree

Claudia Filippini, PhD

Phone

+390116336140

claudia.filippini@unito.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vito Marco VM Ranieri, MD

Organizational Affiliation

University of Turin, Italy

Official's Role

Study Chair

Facility Information:

Facility Name

University of Turin - Department of Anesthesia and Intensive Care Medicine

City

Turin

ZIP/Postal Code

10126

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniela Pasero, MD

Phone

+390116336129

daniela.pasero@unito.it

12. IPD Sharing Statement

Learn more about this trial

CPAP Reduces Hypoxemia After Cardiac Surgery

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