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Protocolized Ventilator Weaning Verses Usual Care

NCT03724643 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4200

Last updated 2018-10-30

No results posted yet for this study

Summary

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).

Conditions

Interventions

OTHER

Protocolized wean

Respiratory therapist determined extubation readiness based on: patent and protected airway; adequate secretion clearance; suction requirement ≤ every 2 hours; FiO2 \< 50% and PEEP = 5; and hemodynamic stability without circulatory support. The SBT included CPAP = 5 mmHg at FiO2 ≤ 0.4. Patients were assessed after 3-minutes for appropriateness to continue (SaO2 ≥ 92%; no arrhythmia; RSBI \< 105 breaths/min/L). Respiratory distress signs included RR \> 30 breaths/min, SaO2\< 90%, HR \> 140 beats/min, or a sustained change in HR of \>20%, systolic BP \>200 mmHg or \<80 mmHg, or agitation, anxiety, or diaphoresis without other cause. The SBT lasted 120 min in accordance with prior studies. Upon SBT completion, the RSBI was re-measured and an ABG was obtained.

Sponsors & Collaborators

  • Baqiyatallah Medical Sciences University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-18
Primary Completion
2014-05-03
Completion
2017-08-20

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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 NCT03724643 on ClinicalTrials.gov