Respiratory Failure Clinical Trial
Official title:
Protocolized Ventilator Weaning Verses Usual Care: A Randomized Controlled Trial
Verified date | October 2018 |
Source | Baqiyatallah Medical Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Protocol-driven ventilator weaning strategies utilizing spontaneous breathing trials (SBT) reportedly result in shorter intubation duration and intensive care unit (ICU) length-of-stay (LOS). Investigators compared respiratory therapy (RT)-driven protocolized ventilator weaning (PW) verses usual care (UC) as it pertains to physiologic respiratory parameters, intubation duration, extubation success/reintubation rates, and ICU LOS. The study was a prospective multicenter randomized controlled trial in 6 ICUs at 6 academic-affiliated hospitals in a resource limited setting. Extubation readiness was determined by the attending physician (UC) or the respiratory therapist (PW) using pre-defined criteria and SBT. Physiologic variables, serial blood gas measurements, and weaning indices were assessed including rapid shallow breathing index (RSBI), negative inspiratory force (NIF), occlusion pressure (P0.1), dynamic and static compliance (Cdyn and Cs).
Status | Completed |
Enrollment | 4200 |
Est. completion date | August 20, 2017 |
Est. primary completion date | May 3, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Admitted to the ICU - Endotracheally intubated on mechanical ventilation = 24 hours - Full-code status - Informed consent provided by the patient, legal guardian, or healthcare surrogate (prior to ventilator weaning). Exclusion Criteria: - Declining consent - Death without ventilator weaning - Cardiopulmonary arrest on the ventilator - Permanent ventilator dependence - Tracheostomy placement for long-term weaning - Self-extubation - Pulmonary edema - Aspiration during the wean - Copious secretions and mucus plugging precluding wean - Severe obstructive lung disease - COPD with hypercapneic respiratory failure - Status-post-respiratory arrest - Concurrent neurologic / neuromuscular comorbidity - Drug or alcohol intoxication - Incomplete data. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Baqiyatallah Medical Sciences University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of Intubation | Duration of mechanical ventilation | through study completion, an average of 30 days | |
Secondary | Hospital length-of-stay | Hospital length-of-stay | through study completion, an average of 30 days |
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