Protocolized Ventilator Weaning Verses Usual Care

NCT03724643 | Completed

• 1 other identifier: BUMS-PWvUC-RCT
• Study Type: interventional
• Target: 4,200
• Locations: 0 countries
• Sites: N/A

Brief 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

Respiratory Failure

Keywords

Mechanical ventilation; Ventilator weaning; Extubation

Outcome Measures

Primary Outcomes (1)

• Duration of Intubation

  Duration of mechanical ventilation

  through study completion, an average of 30 days

Secondary Outcomes (1)

• Hospital length-of-stay

  through study completion, an average of 30 days

Study Arms (2)

Protocolized Wean

EXPERIMENTAL

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.

Other: Protocolized wean

Usual Care

NO INTERVENTION

In the UC group, the SBT type and extubation decision was determined by the attending intensivist on service based upon neurologic status, airway competence (gag, cough, suction requirements), and negative inspiratory force (NIF) or RSBI measurements.

Interventions

Protocolized wean OTHER

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.

Protocolized Wean

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Senior Intensivist Nurse, Baqiyatallah Medical Sciences University

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 30, 2018
• Study Start: October 18, 2007
• Primary Completion: May 3, 2014
• Study Completion: August 20, 2017
• Last Updated: October 30, 2018

Record last verified: 2018-10