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

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.