Status:
COMPLETED
Screening Elderly Patients for Weaning
Lead Sponsor:
Unity Health Toronto
Conditions:
Critically Ill
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
During weaning the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the time on ventilators is spent weaning. Studies support the use of screening protoco...
Detailed Description
In the context of a multicentre, pilot trial in 100 elderly (\>/= 65 years) critically ill adults comparing two strategies to identify weaning candidates ('once daily' vs. 'at least twice daily' scree...
Eligibility Criteria
Inclusion
- The investigators will include:
- elderly (age \>/= 65 years) critically ill adults
- receiving invasive mechanical ventilation for at least 24 hours who can breathe spontaneously on Pressure Support (PS) or trigger breaths on volume or pressure Assist Control (AC), volume or pressure Synchronized Intermittent Mandatory Ventilation (SIMV) ± PS, Pressure Regulated Volume Control (PRVC) or Airway Pressure Release Ventilation (APRV).
- patients must be receiving \</= 70% inspired oxygen
- and a positive end-expiratory pressure of \</= 12 cm H2O (Table 2). .
Exclusion
- The investigators will exclude patients who have already undergone extubation or an SBT, are unlikely to benefit (e.g. moribund, expected brain death), on automated weaning modes, participating in studies with a weaning protocol, and those who can not be optimized with regard to sedation and mobilization.
- Specifically, we will exclude patients:
- admitted after cardiopulmonary arrest or with brain death or expected brain death,
- who have evidence of myocardial ischemia in the 24 hour period before enrollment,
- who have received continuous invasive mechanical ventilation for \>/= 2 weeks,
- who have a tracheostomy in situ at the time of screening,
- who are receiving sedative infusions for seizures or alcohol withdrawal,
- who require escalating doses of sedative agents,
- who are receiving neuromuscular blockers or who have known quadriplegia, paraplegia or 4 limb weakness or paralysis preventing active mobilization (e.g., active range of motion, exercises in bed, sitting at edge of bed, transferring from bed to chair, standing, marching in place, ambulating),
- who are moribund (e.g., at imminent risk for death) or who have limitations of treatment (e.g., withdrawal of support, do not reintubate order, however, do not resuscitate orders will be permitted),
- who have profound neurologic deficits (e.g. large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) \</= 6,
- who are using modes that automate SBT conduct,
- who are current enrolled in a confounding study that includes a weaning protocol,
- who were previously enrolled in this trial,
- patients who have already undergone an SBT or
- patients who have already undergone extubation \[planned, unplanned (e.g. self, accidental)\] during the same ICU admission.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT02243449
Start Date
January 1 2015
End Date
December 1 2015
Last Update
October 20 2017
Active Locations (8)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada
2
Hamilton General Hospital
Hamilton, Ontario, Canada
3
St Joseph's Hospital
Hamilton, Ontario, Canada
4
Ottawa General Hospital
Ottawa, Ontario, Canada