The Frequency of Screening and SBT Technique Trial: The FAST Trial



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:16 - Any
Updated:12/7/2018
Start Date:January 18, 2018
End Date:March 2021
Contact:Karen Burns, MD, FRCPC
Email:burnsk@smh.ca
Phone:416-864-6060

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The Frequency of Screening and SBT Technique Trial: The FAST Trial, A North American Weaning Collaboration

Background: The sickest patients who are admitted to an intensive care unit (ICU) often
require assistance with their breathing. When patients start to get better, they gradually do
more of the breathing and the machine does less—this is called weaning. Although ventilator
use saves lives, the longer it is used, the more complications can occur. Clinicians aim to
wean patients from ventilators in a timely and safe manner. In most ICUs, patients are
screened (looked at) once per day to see if they are ready to undergo a weaning test (using a
variety of techniques) to see if the breathing tube can be removed. Screening more than once
per day may allow more weaning tests to be conducted. Knowing the best way to do a weaning
test is important because some methods may better determine who can have the breathing tube
removed safely. At present, we don't know the best way to help our sickest patients to wean
from ventilators.

Patients: Adults in North American ICUs who are on ventilators for at least 24 hours and who
can take breaths on their own.

Interventions: Patients in our study will receive one type of screening and one type of
weaning test at random. In the 'once daily' screening groups, clinicians will screen patients
each morning. In the 'two or more times daily screening' groups, patients will be screened in
the morning, afternoon, and whenever else clinicians wish to screen. When screening criteria
are met, patients will undergo one of two weaning tests with low ventilator support or no
support.

Outcomes: The main outcome of this study will be the time for patients to be successfully
removed from the ventilator.

Relevance: For patients, this study will clarify the best way to remove them from ventilators
in a timely and safe manner. For clinicians and our health care systems, this study holds
promise to improve how critically ill patients are weaned from breathing machines.

Goals

1. To identify the best strategy to wean patients from ventilators.

2. To fully engage patients and family members (PFM) in our trial.

Rationale: Nearly 40% of the time on invasive ventilation is spent weaning. In minimizing
patients' exposure to invasive ventilation, clinicians are challenged by a trade-off between
the complications associated with protracted ventilation and the risks [ventilator-associated
pneumonia (VAP), mortality] of premature, failed attempts at extubation. Although randomized
trials have been conducted to evaluate different screening practices and spontaneous
breathing trial (SBT) techniques, most trials were small, predated daily screening, and have
limited generalizability to the North American (NA) context where weaning involves
respiratory therapists (RTs) and physicians.

In a systematic review of 17 trials (n=2,434), we found that screening protocols, compared to
usual care, were associated with a 26% reduction in total duration of ventilation, a 70%
reduction in weaning time, and an 11% reduction in ICU stay. Only 1 trial (n=385) compared
twice daily screening to usual care and found that patients screened twice daily spent
significantly less time on ventilators. Once daily screening is poorly aligned with the
continuous care ICU environment. In our international survey, Pressure Support (PS) with
positive end-expiratory pressure (PEEP) and T-piece were the most commonly used SBT
techniques. Concerns exist that PS and T-piece SBTs may over and underestimate, respectively,
patients' ability to breathe after extubation. Only 1 trial (n=484) has compared T-piece and
PS SBTs and found no difference in outcomes. This trial was conducted in Europe, predated
daily screening, and was underpowered.

Design: The investigators will conduct a factorial design trial involving 760 patients in 20
NA ICUs.

Population: The investigators will enroll critically ill adults receiving invasive
ventilation for > 24 hours who can initiate or trigger breaths on commonly used weaning
modes.

Comparators: Patients will be randomized to undergo a screening frequency (once vs. at least
twice daily) AND an SBT technique (T-piece vs. PS ± PEEP).

Outcomes: The primary outcome will be the time to successful extubation. Secondary outcomes
will include general and ventilation-specific outcomes that are important to citizens. We
expect that more frequent screening, regardless of SBT technique, will reduce time to
successful extubation.

This trial will identify the best strategy to reduce the time patients spend on ventilators
and in ICUs, clarify best weaning practices, enhance care delivery, and launch a new paradigm
of engagement into our research.

Inclusion Criteria:

1. Receiving invasive mechanical ventilation for > or = 24 hours.

2. Capable of initiating spontaneous breaths or triggering the ventilator to give a
breath on ventilator modes commonly used in the ICU.

3. Fractional concentration of inspired oxygen (FiO2) < or = 70%.

4. Positive End-Expiratory pressure (PEEP) < or = 12 cm H2O.

Exclusion Criteria:

1. Brain death or expected brain death.

2. Evidence of myocardial ischemia in the 24 hour period before enrollment. Except if
current trend in troponin is downward AND it has been > or = 24 hours since last
troponin peak or the patient has undergone a revascularization procedure and attending
physician has no concerns regarding ongoing ischemia.

3. Received continuous invasive mechanical ventilation for > or = 2 weeks.

4. Tracheostomy in situ at the time of screening.

5. Receiving a sedative infusion(s) for seizures or alcohol withdrawal.

6. Require escalating doses of sedative agents.

7. Receiving neuromuscular blockers or who have known quadriplegia, paraplegia or 4 limb
weakness or paralysis preventing active mobilization.

8. Moribund (e.g., at imminent risk for death) or who have limitations of treatment.

9. Profound neurologic deficits (e.g., post cardiac or respiratory arrest, large
intracranial stroke or bleed) or Glasgow Coma Scale (GCS) < or = 6.

10. Use of ventilator modes that automate SBT conduct.

11. Currently enrolled in a confounding study that includes a weaning protocol.

12. Previous enrollment in this trial.

13. Previous SBT or are already on T-piece, or CPAP alone (without PS), or PS < or equal 8
cm H2O regardless of PEEP, or other 'SBT equivalent' settings immediately before
randomization.

14. Previous extubation [planned, unplanned (e.g. self, accidental)] during the same ICU
admission.
We found this trial at
6
sites
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Robert Hyzy
University of Michigan Health System The University of Michigan is home to one of the...
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Edmonton, Alberta
Principal Investigator: Jim Kutsogiannis
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Edmonton,
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Long Beach, California 90806
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Long Beach, CA
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Los Angeles, California 90033
Principal Investigator: Alfredo Lee Chang
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Los Angeles, CA
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