Critically IllNCT02969226
The Frequency of Screening and SBT Technique Trial: The FAST Trial
A study testing Once daily screening, Twice daily screening and PS SBTs in people with Critically Ill, run by Unity Health Toronto at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Once daily screening, Twice daily screening and PS SBTs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 18 Jan 2018to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Canada12 sites, 12 recruiting
- Not yet recruiting
Royal Alexandra Hospital
Edmonton, Alberta, T5H3V9
Jim Kutsogiannis
- Recruiting
Hamilton Health Sciences Hamilton General Hospital
Hamilton, Ontario, L8L2X2
Maureen Meade
- Recruiting
Juravinski Hospital Cancer Centre
Hamilton, Ontario
Bram Rochwerg, MD
- Recruiting
St. Joseph's Hospital
Hamilton, Ontario
Deborah J Cook, MD, FRCPC
- Recruiting
Niagara Health - St. Catharines
Niagara, Ontario, L2S 0A9
Jennifer Tsang
Eric Duan
- Recruiting
Ottawa General Hospital
Ottawa, Ontario
Andrew Seely, MD, FRCPC
- Recruiting
Universite de Sherbooke
Sherbrooke, Quebec
Francois Lamontagne, MD, FRCPC
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Leena Rizvi
- Not yet recruiting
St. Joseph's Health Centre
Toronto, Ontario
Robert Cirone, MD
- Recruiting
St. Michael's Hospital
Toronto, Ontario
Karen Burns, MD, FRCPC
- Recruiting
Ciusss McQ
Trois-Rivières, Quebec, G9A5C5
Ying Sia
Emmanual Charbonney
- Not yet recruiting
St. Paul's Hospital
Vancouver, British Columbia
Peter Dodek, MD, FRCPC
United States5 sites, 5 recruiting
- Recruiting
University of Michigan Health System
Ann Arbor, Michigan, 48109
Robert Hyzy
- Not yet recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
John Devlin, MD
Nicholas Hill, MD
- Recruiting
Longbeach Memorial Hospital
Long Beach, California, 90806
Maged Tanios, MD
- Not yet recruiting
Keck Hospital of USC
Los Angeles, California, 90033
Alfredo Lee Chang
Janice Liebler
- Not yet recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Gerard Criner, MD
About this study
Official title: The Frequency of Screening and SBT Technique Trial: The FAST Trial, A North American Weaning Collaboration
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.
Read more
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.
Read the detailed description
Goals
- To identify the best strategy to wean patients from ventilators.
- 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.
- Conditions
- Critically Ill
- Being tested
- Once daily screening, Twice daily screening, PS SBTs, T-piece SBTs
- Keywords
- mechanical ventilation, weaning, critically ill, spontaneous breathing trial, screening, invasive ventilation, SBT technique
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Once daily screeningProcedure or surgery
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 screeningProcedure or surgery
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 SBTsProcedure or surgery
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 SBTsProcedure or surgery
Patients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece (off the ventilator)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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). Receives: Procedure: Twice daily screening; Procedure: T-piece SBTs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful extubation
time from randomization to successful extubation
Measured: 3-4 years
Secondary outcomes (10)
ICU mortality
during index ICU admission
Measured: 3-4 years
Hospital and 90 day mortality
during index hospital admission
Measured: 3-4 years
Time to first passing an SBT
from randomization to SBT
Measured: 3-4 years
Total duration of mechanical ventilation (invasive and noninvasive),
time randomization to successful extubation
Measured: 3-4 years
ICU length of stay
reported from index ICU admission and randomization to index ICU discharge
Measured: 3-4 years
Hospital length of stay
reported from index hospital admission and randomization to index hospital discharge
Measured: 3-4 years
Use of NIV after extubation
Binary - yes vs no
Measured: 3-4 years
Adverse events (e.g., self-extubation, tracheostomy, reintubation, prolonged ventilation at d14 and d21, ICU readmission)
binary - yes vs no
Measured: 3-4 years
HRQoL (EuroQuol EQ-5D) 6 months after randomization
using HRQoL questionnaire
Measured: 6 months after randomization
Functional status 6 months after randomization using either the IES-R, Lawton ADL scale, or the FIM
using Functional status questionnaire
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start18 Jan 2018
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Burns, MD, FRCPC, Principal investigator, St. Michael's Hospital (Toronto, Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969226
- Sponsor's protocol ID
- FAST-002
- Status last verified
- Dec 2018
- First submitted
- 17 Nov 2016
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39382222
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Screening and SBT Technique Trial: The FAST Trial, A North American Weaning Collaboration
- ClinicalTrials.gov ID
- NCT02969226
- Acronym / sponsor ID
- FAST-002
- Conditions
- Critically Ill
- Keywords
- mechanical ventilation, weaning, critically ill, spontaneous breathing trial, screening, invasive ventilation, SBT technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Goals
- To identify the best strategy to wean patients from ventilators.
- 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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Once daily screening + PS SBTs | Active comparator | Procedure: Once daily screening, Procedure: PS SBTsIn 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. |
| At least twice daily screening + PS SBTs | Experimental | Procedure: Twice daily screening, Procedure: PS SBTsIn 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. |
| Once daily screening + T-piece SBTs | Active comparator | Procedure: Once daily screening, Procedure: T-piece SBTsIn 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). |
| At least twice daily screening + T-piece SBTs | Active comparator | Procedure: Twice daily screening, Procedure: T-piece SBTsIn 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). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Once daily screeningRTs 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 or surgery | Once daily screening + PS SBTs, Once daily screening + T-piece SBTs |
| Twice daily screeningIn 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 or surgery | At least twice daily screening + PS SBTs, At least twice daily screening + T-piece SBTs |
| PS SBTsPatients 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 | Procedure or surgery | At least twice daily screening + PS SBTs, Once daily screening + PS SBTs |
| T-piece SBTsPatients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece (off the ventilator) | Procedure or surgery | At least twice daily screening + T-piece SBTs, Once daily screening + T-piece SBTs |
Primary outcome
Time to successful extubation
Time frame: 3-4 years
time from randomization to successful extubation
10 secondary outcomes
ICU mortality
Time frame: 3-4 years
Hospital and 90 day mortality
Time frame: 3-4 years
Time to first passing an SBT
Time frame: 3-4 years
Total duration of mechanical ventilation (invasive and noninvasive),
Time frame: 3-4 years
ICU length of stay
Time frame: 3-4 years
Hospital length of stay
Time frame: 3-4 years
Use of NIV after extubation
Time frame: 3-4 years
Adverse events (e.g., self-extubation, tracheostomy, reintubation, prolonged ventilation at d14 and d21, ICU readmission)
Time frame: 3-4 years
HRQoL (EuroQuol EQ-5D) 6 months after randomization
Time frame: 6 months after randomization
Functional status 6 months after randomization using either the IES-R, Lawton ADL scale, or the FIM
Time frame: 6 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Derived from this study: PubMed 39382222Burns 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Burns, MD, FRCPC principal investigator
St. Michael's Hospital (Toronto, Canada)
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Once daily screening, Twice daily screening and PS SBTs in people with Critically Ill, run by Unity Health Toronto at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Burns, MD, FRCPC (416-864-6060 ext. 3567, burnsk@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to successful extubation (time frame: 3-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02969226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.