Post Extubation Respiratory Failure, Re-intubation, Septic Shock, Severe Sepsis
Conditions
Keywords
Sepsis, Septic shock, Severe sepsis, Extubation, Reintubation, Noninvasive positive pressure ventilation, High flow oxygen nasal cannula
Brief summary
Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation in comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.
Detailed description
Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation. The results from recent randomized controlled trials, comparing HFNC with NIV for prevent post extubation respiratory failure among post cardiac surgery and high risk patients, showed no significant different in the treatment outcome.comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients. About 40-85% of severe sepsis/septic shock patients developed acute respiratory failure, required endotracheal intubation. According to the nature of patients population, usually eldery, multiple co-morbid condition and high APACHE II score, sepsis patients were considerred as high risk for reintubation, after extubated. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.
Interventions
Noninvasive positive pressure ventilation will apply via a face mask with initial setting as the following: Inspiratory pressure 6-8 cmH2O Expiratory pressure 3-5 cmH2O FiO2 30-60% Respiratory rate 12-16 per min
High flow oxygen nasal cannula will apply to patient via a nasal cannula with initial setting as the following: Temperature 37 degree celsius Flow 30 liter per min FiO2 40-60%
Sponsors
Mahidol University
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
* Diagnosis of sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) * Depended on mechanical ventilator for more than 48 hours * Plan for extubation due to successful weaning
Exclusion criteria
* Patient with tracheostomy * Recent upper abdominal surgery * Wound at face that prohibit face-mask application * Patient or 1st degree relative not agree to participate trial * Physician prefer either NIV or HFNC for the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device failure rate | an average of 1 year | Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reintubation rate | an average of 1 year | Patient develope respiratory failure, requiring reintubation within 72 hours after extubation |
| 28 day mortality rate | Upto 28 days | Proportion of dead patients to overall patients |
| Hospital mortality rate | an average of 1 year | Proportion of dead patients to overall patients from extubation to discharge date |
Countries
Thailand
Outcome results
None listed