Respiratory Failure Clinical Trial
Official title:
Protocolized Ventilator Weaning Verses Usual Care: A Randomized Controlled Trial
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).
This was a prospective multicenter randomized controlled trial in 6 closed ICUs with 24/7
in-house intensivist coverage at 6 academic-affiliated medical centers in a resource limited
setting from October 18, 2007 to May 03, 2014. All parts of the study were reviewed according
to the Consolidated Standards for Reporting Trials (CONSORT) statement. Crossover was not
allowed. Participants were blinded to randomization group, as were the healthcare providers
and statistician. Randomization was accomplished using Random Allocation Software© (RAS;
Informer Technologies, Inc.). Block randomization was performed by a computer generated
random number list prepared by a statistician. Allocation consignment occurred through
confidential communication between the patient's nurse and a third party not involved in
recruitment. The data analyzer was blinded to group randomization and was not present during
ventilator weaning. There were no important changes to methods after trial commencement. The
study ended because it achieved the necessary sample size.
Pparticipants were randomly assigned to ventilator weaning either by protocolized methodology
or by usual care (UC). All patients were ventilated using Dräger Evita® XL or Evita® 4
ventilators (Dräeger Medical, Inc., Lubeck, Germany). In the PW group, weaning and extubation
readiness was determined by the RT using pre-defined criteria and the result of a SBT.
Pre-defined weaning criteria included: (1) patent upper airway; (2) ability to protect airway
(defined by mental status and presence of adequate gag and cough reflexes); (3) ability to
clear secretions; (4) decreasing secretion burden requiring suction not more frequently than
every 2 hours; (5) level of support (FiO2 < 50%, PEEP = 5); and (6) hemodynamic stability not
requiring chemical (vasopressors, inotropes) or mechanical (e.g. intra-aortic balloon pump,
extracorporeal life support) circulatory support. Until the SBT, management of each group was
the same. For patients in the UC group, SBT type and determination to extubate was determined
by attending physician preference. For participants in the PW group, the SBT type was
protocol determined, and extubation decisions were driven by RT. The SBT consisted of
continuous positive airway pressure (CPAP) of 5 mmHg with an FiO2 ≤ 0.4. After 3-minutes
patients were assessed for appropriateness to continue the SBT by arterial oxygen saturation
(SaO2) ≥ 92% without arrhythmias, and a rapid shallow breathing index (RSBI = RR/VT) < 105
breaths/min/L. Specified signs of respiratory distress included respiratory rate (RR)> 30
breaths/minute, SaO2< 90%, heart rate (HR)> 140 breaths/minute, or a sustained increase or
decrease of HR of >20%, systolic blood pressure >200 mmHg or <80 mmHg, or agitation, anxiety,
or diaphoresis without other identified cause. The SBT was performed for 120 min in
accordance with prior studies. At the end of the SBT, the RSBI was re-measured and an
arterial blood gas (ABG) was obtained.
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. Extubation success
was defined as remaining extubated for 48 hours without need for re-intubation or other forms
of non-invasive MV.
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