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

Status unconfirmed · Not applicable

Conditions studied: Critically Ill

In brief

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.

Key facts

Study ID

NCT02969226

Run by

Unity Health Toronto

People needed

760

Starts

2018-01-18

Expected to finish

2021-03-01

Last updated by the study team

2018-12-05

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Receiving invasive mechanical ventilation for > or = 24 hours.
• Capable of initiating spontaneous breaths or triggering the ventilator to give a breath on ventilator modes commonly used in the ICU.
• Fractional concentration of inspired oxygen (FiO2) < or = 70%.
• Positive End-Expiratory pressure (PEEP) < or = 12 cm H2O.

You may not qualify if…

• Brain death or expected brain death.
• 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.
• Received continuous invasive mechanical ventilation for > or = 2 weeks.
• Tracheostomy in situ at the time of screening.
• Receiving a sedative infusion(s) for seizures or alcohol withdrawal.
• Require escalating doses of sedative agents.
• Receiving neuromuscular blockers or who have known quadriplegia, paraplegia or 4 limb weakness or paralysis preventing active mobilization.
• Moribund (e.g., at imminent risk for death) or who have limitations of treatment.
• Profound neurologic deficits (e.g., post cardiac or respiratory arrest, large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) < or = 6.
• Use of ventilator modes that automate SBT conduct.
• Currently enrolled in a confounding study that includes a weaning protocol.
• Previous enrollment in this trial.
• 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.
• Previous extubation [planned, unplanned (e.g. self, accidental)] during the same ICU admission.

Where it is running

• Ciusss McQ — Trois-Rivières, Quebec, Canada (enrolling)
• Niagara Health - St. Catharines — Niagara, Ontario, Canada (enrolling)
• Ottawa General Hospital — Ottawa, Ontario, Canada (enrolling)
• St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
• St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
• Universite de Sherbooke — Sherbrooke, Quebec, Canada (enrolling)
• Longbeach Memorial Hospital — Long Beach, California, United States (enrolling)
• University of Michigan Health System — Ann Arbor, Michigan, United States (enrolling)
• Hamilton Health Sciences Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)
• Juravinski Hospital Cancer Centre — Hamilton, Ontario, Canada (enrolling)
• St. Joseph's Hospital — Hamilton, Ontario, Canada (enrolling)
• Keck Hospital of USC — Los Angeles, California, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• St. Joseph's Health Centre — Toronto, Ontario, Canada
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Royal Alexandra Hospital — Edmonton, Alberta, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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