The Frequency of Screening and SBT Technique Trial: The FAST Trial
Critically Ill
About this trial
This is an interventional screening trial for Critically Ill focused on measuring mechanical ventilation, weaning, critically ill, spontaneous breathing trial, screening, invasive ventilation, SBT technique
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Longbeach Memorial HospitalRecruiting
- Keck Hospital of USC
- Tufts Medical Center
- University of Michigan Health SystemRecruiting
- Temple University Hospital
- Royal Alexandra Hospital
- St. Paul's Hospital
- Hamilton Health Sciences Hamilton General HospitalRecruiting
- Juravinski Hospital Cancer CentreRecruiting
- St. Joseph's HospitalRecruiting
- Niagara Health - St. CatharinesRecruiting
- Ottawa General HospitalRecruiting
- St. Michael's HospitalRecruiting
- St. Joseph's Health Centre
- St. Michael's HospitalRecruiting
- Universite de SherbookeRecruiting
- Ciusss McQRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Active Comparator
Active Comparator
Once daily screening + PS SBTs
At least twice daily screening + PS SBTs
Once daily screening + T-piece SBTs
At least twice daily screening + T-piece SBTs
In this arm, RTs will screen patients between approximately 06:00 - 08:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only PS> 0 and =< 8 cm H2O with PEEP> 0 and =< 5 cm H2O.
In this arm patients will be screened at a minimum between approximately 06:00 - 08:00 hours and 13:00 - 15:00 hs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Additional screening trials in the 'at least twice daily' screening arm will be permitted at the discretion of the clinical team [RTs and physicians]. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only PS>0 and =< 8 cm H2O with PEEP>0 and =< 5 cm H2O.
In this arm + PS SBT' arm, RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only T-piece (off the ventilator).
In this arm, RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. If a screening period is missed inadvertently In the 'at least twice daily + PS SBT' screening arm patients will be screened at a minimum between approximately 06:00 - 08:00 hrs and 13:00 - 15:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hours of the scheduled screening period. Additional screening trials in the 'at least twice daily' screening arm will be permitted at the discretion of the clinical team (RTs and physicians). Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only T-piece (off the ventilator).