CPAP Reduces Hypoxemia After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Respiratory Failure Requiring Reintubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TREATMENT

Helmet CPAP

Group Type EXPERIMENTAL

Helmet CPAP

Intervention Type PROCEDURE

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.

CONTROL

Venturi Mask

Group Type ACTIVE_COMPARATOR

Venturi Mask

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No