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

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ClinicalTrials.gov Identifier: NCT02969226
Recruitment Status : Unknown
Verified December 2018 by Unity Health Toronto.
Recruitment status was:  Recruiting
First Posted : November 21, 2016
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

Study Description
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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.


Condition or disease Intervention/treatment Phase
Critically Ill Procedure: Once daily screening Procedure: Twice daily screening Procedure: PS SBTs Procedure: T-piece SBTs Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Frequency of Screening and SBT Technique Trial: The FAST Trial, A North American Weaning Collaboration
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021
Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: 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.

Procedure: 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
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.
 Procedure: 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.

Procedure: 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
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).
 Procedure: 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.

Procedure: T-piece SBTs
Patients are assigned a SBT technique. All SBTs for these patients must be conducted with 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).
 Procedure: 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.

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


Outcome Measures
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Primary Outcome Measures :
  1. Time to successful extubation [ Time Frame: 3-4 years ]
    time from randomization to successful extubation


Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: 3-4 years ]
    during index ICU admission

  2. Hospital and 90 day mortality [ Time Frame: 3-4 years ]
    during index hospital admission

  3. Time to first passing an SBT [ Time Frame: 3-4 years ]
    from randomization to SBT

  4. Total duration of mechanical ventilation (invasive and noninvasive), [ Time Frame: 3-4 years ]
    time randomization to successful extubation

  5. ICU length of stay [ Time Frame: 3-4 years ]
    reported from index ICU admission and randomization to index ICU discharge

  6. Hospital length of stay [ Time Frame: 3-4 years ]
    reported from index hospital admission and randomization to index hospital discharge

  7. Use of NIV after extubation [ Time Frame: 3-4 years ]
    Binary - yes vs no

  8. Adverse events (e.g., self-extubation, tracheostomy, reintubation, prolonged ventilation at d14 and d21, ICU readmission) [ Time Frame: 3-4 years ]
    binary - yes vs no

  9. HRQoL (EuroQuol EQ-5D) 6 months after randomization [ Time Frame: 6 months after randomization ]
    using HRQoL questionnaire

  10. Functional status 6 months after randomization using either the IES-R, Lawton ADL scale, or the FIM [ Time Frame: 6 months after randomization ]
    using Functional status questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969226


Contacts
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Contact: Karen Burns, MD, FRCPC 416-864-6060 ext 3567 burnsk@smh.ca
Contact: Leena Rizvi, BSc. 416-864-6060 ext 2938 rizvil@smh.ca

Locations
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Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: Karen Burns, MD, FRCPC St. Michael's Hospital (Toronto, Canada)
More Information
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT02969226    
Other Study ID Numbers: FAST-002
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Health Toronto:
mechanical ventilation
weaning
critically ill
spontaneous breathing trial
 screening
invasive ventilation
SBT technique
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes