Screening Frequency Trial to Identify Weaning Candidates

NCT02001220 | Completed

• 1 other identifier: 151113
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 8

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 protocols and tests of patient's ability to breathe spontaneously (SBTs) to identify weaning candidates. Once daily screening is the current standard of care. With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant opportunity exists to screen patients more frequently, conduct more SBTs, and reduce the time spent on ventilators and in the ICU. The study is seeking to identify the optimal screening frequency to minimize patients' exposure to invasive ventilation. The RELEASE Trial will evaluate a simple a simple construct: more frequent screening will result In earlier identification of weaning candidates, more frequent SBT's, and less time spent on ventilators and in the ICU. More frequent screening is an appealing intervention because it is sensible, low risk, and represents a cost effective use of current resources. This simple intervention holds promise as a strategy that could change clinical practice, enhance the care delivered to critically ill adults, and improve clinically important outcomes.

Conditions

Critically Ill

Keywords

screening; invasive ventilation; mechanical ventilation; weaning; spontaneous breathing trials

Outcome Measures

Primary Outcomes (1)

• To demonstrate our ability to recruit the desired population (1-2 patients, per centre per month, on average)

  2 years

Secondary Outcomes (3)

• To evaluate clinician compliance with 'once daily' versus 'at least twice daily' screening assessments and the potential for contamination in the 'once daily' arm

  2 years

• Assess current practices related to sedation, analgesia and delirium management and mobilization before conducting 'once daily' or 'at least twice daily screening' assessments

  2 years

• Identify barriers (clinician and institutional) to recruitment

  2 years

Other Outcomes (2)

• Classify trial participants as requiring (i) simple, (ii) difficult or (iii) prolonged weaning using the 'Task Force on Weaning' definitions.

  2 years

• Obtain preliminary estimates of the impact of the alternative screening strategies ('once daily' vs. 'at least twice daily'') on clinically important outcomes

  2 years

Study Arms (2)

Once daily screening

ACTIVE COMPARATOR

Patients will undergo assessments to determine readiness to undergo an SBT once daily.

Procedure: Once daily screening

At least twice daily screening

EXPERIMENTAL

Patients will undergo assessments to determine readiness to undergo an SBT at least twice daily.

Procedure: At least twice daily screening

Interventions

Once daily screening PROCEDURE

In the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. The initial SBT will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, CPAP \< to 5 cm H2 O or PS \< 8 cm H2 O with PEEP \< 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and use of different humidification strategies. Each centre will choose one technique to be used for all patients enrolled at their centre.

Once daily screening

At least twice daily screening PROCEDURE

In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 6:00-8:00 hours and 13:00-15:00 hours daily. Initial SBT will be conducted in the same manner as once daily screening arm. Subsequent SBTs will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, CPAP \< to 5 cm H2 O or PS \< 8 cm H2 O with PEEP \< 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O). Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and use of different humidification strategies. Each centre will be asked to choose one technique to be used for all patients enrolled at their centre.

At least twice daily screening

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving invasive mechanical ventilation for ≥ 24 hours.
• Capable of initiating spontaneous breaths on PS or triggering breaths on volume or pressure AC, volume or pressure SIMV ± PS, PRVC, or APRV.
• With an FiO2 ≤ 70%.
• With a PEEP ≤ 12 cm H₂O.
• \< 65 years of age

You may not qualify if:

• Patients admitted after cardiopulmonary arrest or with brain death or expected brain death.
• Patients who have evidence of myocardial ischemia in the 24 hour period before enrollment.
• Patients who have received continuous invasive mechanical ventilation for ≥ 2 weeks.
• Patients who have a tracheostomy in situ at the time of screening.
• Patients who are receiving sedative infusions for seizures or alcohol withdrawal.
• Patients who require escalating doses of sedative agents.
• Patients 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).
• Patients 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).
• Patients who have profound neurologic deficits (e.g., large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) ≤ 6.
• Patients who are using modes that automate SBT conduct.
• Patients who are currently enrolled in a confounding study that includes a weaning protocol.
• Patients who were previously enrolled in this trial.
• Patients who have already undergone an SBT.
• Patients who have already undergone extubation \[planned, unplanned (e.g. self, accidental)\] during the same ICU admission.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (8)

St Paul's Hospital

Vancouver, British Columbia, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Hôpital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Universite de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

• Burns KEA, Wong JTY, Dodek P, Cook DJ, Lamontagne F, Cohen A, Mehta S, Kho ME, Hebert PC, Aslanian P, Friedrich JO, Brochard L, Rizvi L, Hand L, Meade MO, Amaral AC, Seely AJ; Canadian Critical Care Trials Group. Frequency of Screening for Weaning From Mechanical Ventilation: Two Contemporaneous Proof-of-Principle Randomized Controlled Trials. Crit Care Med. 2019 Jun;47(6):817-825. doi: 10.1097/CCM.0000000000003722.

  PMID: 30920411 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen EA Burns, MD, FRCPC

  St. Michael's Hospital and the Li Ka Shing Knowledge Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 4, 2013
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 20, 2017

Record last verified: 2017-10

Locations

CA (8)