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CPAP Reduces Hypoxemia After Cardiac Surgery

NCT01726140 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2025-03-17

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Failure Requiring Reintubation

Interventions

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.

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.

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Vito Marco VM Ranieri, MD · University of Turin, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2023-07-31
Completion
2024-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01726140 on ClinicalTrials.gov