Weaning From Noninvasive Ventilation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypercapnic Respiratory Failure
- Sponsor
- Baskent University
- Enrollment
- 197
- Locations
- 8
- Primary Endpoint
- The comparison of total duration of NIV after randomization
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Noninvasive ventilation (NIV) weaning strategies differ considerably from one another. These strategies have yet not been compared to each other. Therefore, the investigators planned to perform a prospective, randomized, pilot study involving hypercapnic acute respiratory failure patients ready to be weaned off from NIV. The investigators are going to compare the success rate of NIV weaning and the duration of NIV after randomization between 3 NIV weaning methods: gradual decrease in duration of NIV or level of ventilator support, and abrupt discontinuation of NIV.
Investigators
Aylin Ozsancak Ugurlu
MD
Baskent University
Eligibility Criteria
Inclusion Criteria
- •Patients will be screened by the physician 24 hours (±6 hours) after initiation of NIV treatment if:
- •Age ≥18 years old
- •Hypercapnic ARF ( baseline pH\<7.35, paCO2\>45 mmHg, BORG\>4)
- •Breathing frequency\< 25 bpm under NIV
- •pH \>7.35 under NIV
- •10% or more decrease from baseline PaCO2 under NIV
- •Kelly ≤ 2 under NIV (Alert. Follows simple/3 step complex commands)
- •PaO2 between 60 and 70 mmHg under NIV
- •No need for sedation
- •Systolic blood pressure 90-180 mmHg without vasopressors
Exclusion Criteria
- •Age \<18 years old
- •NIV use at home for chronic respiratory failure
- •CPAP use for acute respiratory failure
- •NIV use as palliative treatment
- •Severe heart failure with cardiac index ≤ 2 L/min/m2
- •Severe hepatic failure with bilirubin ≥ 34.2µmol/L
- •Severe renal failure with creatinine ≥ 220 µmol/L
Outcomes
Primary Outcomes
The comparison of total duration of NIV after randomization
Time Frame: up to 10 days
The patients will be considered as 'weaning failure' if: * The participant will meet the NIV reinstitution or intubation criteria during the weaning phase or within the first 5 days of NIV discontinuation * Weaning from NIV was not possible If the failing patient stabilizes afterwards and passes the screening and weaning criteria, the patient will be weaned again with the same protocol. If the patient fails weaning trials 3 times, then the patient will not be re-considered for further enrollment.
Secondary Outcomes
- NIV weaning success rates(10 days of NIV discontinuation)
- Rate of NIV re-institution(10 days of NIV discontinuation)
- Duration of ICU stay(up to 24 weeks)
- Rates of intubation(first 5 days of NIV discontinuation)
- In-hospital mortality(up to 24 weeks)