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

NCT02969226 | Unknown

• 1 other identifier: FAST-002
• Study Type: interventional
• Target: 760
• Locations: 2 countries
• Sites: 17

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to successful extubation

  time from randomization to successful extubation

  3-4 years

Secondary Outcomes (10)

• ICU mortality

  3-4 years

• Hospital and 90 day mortality

  3-4 years

• Time to first passing an SBT

  3-4 years

• Total duration of mechanical ventilation (invasive and noninvasive),

  3-4 years

• ICU length of stay

  3-4 years

Study Arms (4)

Once daily screening + PS SBTs

ACTIVE COMPARATOR

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.

Procedure: Once daily screening; Procedure: PS SBTs

At least twice daily screening + PS SBTs

EXPERIMENTAL

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.

Procedure: Twice daily screening; Procedure: PS SBTs

Once daily screening + T-piece SBTs

ACTIVE COMPARATOR

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).

Procedure: Once daily screening; Procedure: T-piece SBTs

At least twice daily screening + T-piece SBTs

ACTIVE COMPARATOR

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).

Procedure: Twice daily screening; Procedure: T-piece SBTs

Interventions

Once daily screening PROCEDURE

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.

Once daily screening + PS SBTs; Once daily screening + T-piece SBTs

Twice daily screening PROCEDURE

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.

At least twice daily screening + PS SBTs; At least twice daily screening + T-piece SBTs

PS SBTs PROCEDURE

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

At least twice daily screening + PS SBTs; Once daily screening + PS SBTs

T-piece SBTs PROCEDURE

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

At least twice daily screening + T-piece SBTs; Once daily screening + T-piece SBTs

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (17)

Longbeach Memorial Hospital

Long Beach, California, 90806, United States

RECRUITING

Keck Hospital of USC

Los Angeles, California, 90033, United States

NOT YET RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

NOT YET RECRUITING

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

NOT YET RECRUITING

Royal Alexandra Hospital

Edmonton, Alberta, T5H3V9, Canada

NOT YET RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, Canada

NOT YET RECRUITING

Hamilton Health Sciences Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

RECRUITING

Juravinski Hospital Cancer Centre

Hamilton, Ontario, Canada

RECRUITING

St. Joseph's Hospital

Hamilton, Ontario, Canada

RECRUITING

Niagara Health - St. Catharines

Niagara, Ontario, L2S 0A9, Canada

RECRUITING

Ottawa General Hospital

Ottawa, Ontario, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

St. Joseph's Health Centre

Toronto, Ontario, Canada

NOT YET RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

RECRUITING

Universite de Sherbooke

Sherbrooke, Quebec, Canada

RECRUITING

Ciusss McQ

Trois-Rivières, Quebec, G9A5C5, Canada

RECRUITING

Related Publications (1)

• Burns KEA, Wong J, Rizvi L, Lafreniere-Roula M, Thorpe K, Devlin JW, Cook DJ, Seely A, Dodek PM, Tanios M, Piraino T, Gouskos A, Kiedrowski KC, Kay P, Mitchell S, Merner GW, Mayette M, D'Aragon F, Lamontagne F, Rochwerg B, Turgeon A, Sia YT, Charbonney E, Aslanian P, Criner GJ, Hyzy RC, Beitler JR, Kassis EB, Kutsogiannis DJ, Meade MO, Liebler J, Iyer-Kumar S, Tsang J, Cirone R, Shanholtz C, Hill NS; Canadian Critical Care Trials Group. Frequency of Screening and Spontaneous Breathing Trial Techniques: A Randomized Clinical Trial. JAMA. 2024 Dec 3;332(21):1808-1821. doi: 10.1001/jama.2024.20631.

  PMID: 39382222 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Burns, MD, FRCPC

  St. Michael's Hospital (Toronto, Canada)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Burns, MD, FRCPC

CONTACT

416-864-6060; burnsk@smh.ca

Leena Rizvi, BSc.

CONTACT

416-864-6060; rizvil@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: January 18, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); CA (12)