CPAP Reduces Hypoxemia After Cardiac Surgery

University of Turin, Italy407 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

407

Conditions

Acute Respiratory Failure Requiring Reintubation

Interventions

Helmet CPAPPROCEDURE

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 MaskPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Turin - Department of Anesthesia and Intensive Care Medicine

Turin, Italy

Outcomes

Primary Outcomes

rate of re-intubation

Time frame: at 28 days

Secondary Outcomes

incidence of atelectasis

Time frame: at 28 days

incidence of pneumonia

Time frame: at 28 days

incidence of sepsis

Time frame: at 28 days

mortality rate

Time frame: at 28 days

the intensive care unit length of stay

Time frame: at 28 days

hospital length of stay

Time frame: at 28 days

Data from ClinicalTrials.gov

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