Recruiting

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

Sponsor:

Unity Health Toronto

Code:

NCT02969226

Conditions

Critically Ill

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Once daily screening

Twice daily screening

PS SBTs

T-piece SBTs

Study Details

Brief summary:

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.

Conditions

Critically Ill

Study ID

NCT02969226

Start date

Jan 18, 2018

Status verified date

Dec, 2018

Completion date

Mar, 2021

Anticipated

Primary completion date

Mar, 2021

Anticipated

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

760 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Once daily screening + PS 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.

experimental: At least twice daily screening + PS SBTs

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.

active comparator: Once daily screening + T-piece SBTs

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).

active comparator: At least twice daily screening + T-piece SBTs

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).

Interventions

Once daily screening

RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.

Twice daily screening

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. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.

PS SBTs

Patients are assigned a SBT technique. All SBTs for these patients must be conducted on PS >0 and =< 8 cm H2O with PEEP>0 and =< 5 cm H2O

T-piece SBTs

Patients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece (off the ventilator)

Primary outcome measure

Time to successful extubation [ Time Frame: 3-4 years ]

Central Contacts and Locations

Central contacts

Karen Burns, MD, FRCPC

416-864-6060 burnsk@smh.ca

Leena Rizvi, BSc.

416-864-6060 rizvil@smh.ca

Locations

Longbeach Memorial Hospital

Recruiting

Long Beach, California, United States, 90806

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Robert Hyzy

Hamilton Health Sciences Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L2X2

Principal Investigator:

Maureen Meade

Juravinski Hospital Cancer Centre

Recruiting

Hamilton, Ontario, Canada

St. Joseph's Hospital

Recruiting

Hamilton, Ontario, Canada

Niagara Health - St. Catharines

Recruiting

Niagara, Ontario, Canada, L2S 0A9

Principal Investigator:

Jennifer Tsang

Ottawa General Hospital

Recruiting

Ottawa, Ontario, Canada

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Karen Burns, MD, FRCPC

Universite de Sherbooke

Recruiting

Sherbrooke, Quebec, Canada

Ciusss McQ

Recruiting

Trois-Rivières, Quebec, Canada, G9A5C5

Principal Investigator:

Ying Sia

More Information

Sponsor

Unity Health Toronto

Last update posted

Dec 5, 2018

Last verified

Dec, 2018

Keywords

mechanical ventilation
weaning
critically ill
spontaneous breathing trial
screening
invasive ventilation
SBT technique

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2018-12-05.