Acute Respiratory Failure Requiring Reintubation
Conditions
Keywords
intubation, respiratory failure, cardiac surgery
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.
Interventions
PROCEDUREHelmet 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.
PROCEDUREVenturi 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
Agenzia Italiana del Farmaco
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of re-intubation | at 28 days |
Secondary
| Measure | Time frame |
|---|---|
| incidence of pneumonia | at 28 days |
| incidence of sepsis | at 28 days |
| incidence of atelectasis | at 28 days |
| the intensive care unit length of stay | at 28 days |
| hospital length of stay | at 28 days |
| mortality rate | at 28 days |
Countries
Italy
Outcome results
None listed