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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.
Goals
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to successful extubation | time from randomization to successful extubation | 3-4 years |
| Measure | Description | Time Frame |
|---|---|---|
| ICU mortality | during index ICU admission | 3-4 years |
| Hospital and 90 day mortality | during index hospital admission | 3-4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Burns, MD, FRCPC | Contact | 416-864-6060 | 3567 | burnsk@smh.ca |
| Leena Rizvi, BSc. | Contact | 416-864-6060 | 2938 | rizvil@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Karen Burns, MD, FRCPC | St. Michael's Hospital (Toronto, Canada) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longbeach Memorial Hospital | Recruiting | Long Beach | California | 90806 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39382222 | Derived | 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. |
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| 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). |
|
| 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. |
|
| 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 |
|
| T-piece SBTs | Procedure | Patients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece (off the ventilator) |
|
| Time to first passing an SBT | from randomization to SBT | 3-4 years |
| Total duration of mechanical ventilation (invasive and noninvasive), | time randomization to successful extubation | 3-4 years |
| ICU length of stay | reported from index ICU admission and randomization to index ICU discharge | 3-4 years |
| Hospital length of stay | reported from index hospital admission and randomization to index hospital discharge | 3-4 years |
| Use of NIV after extubation | Binary - yes vs no | 3-4 years |
| Adverse events (e.g., self-extubation, tracheostomy, reintubation, prolonged ventilation at d14 and d21, ICU readmission) | binary - yes vs no | 3-4 years |
| HRQoL (EuroQuol EQ-5D) 6 months after randomization | using HRQoL questionnaire | 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 | 6 months after randomization |
| Keck Hospital of USC | Not yet recruiting | Los Angeles | California | 90033 | United States |
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| Tufts Medical Center | Not yet recruiting | Boston | Massachusetts | 02111 | United States |
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| University of Michigan Health System | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Temple University Hospital | Not yet recruiting | Philadelphia | Pennsylvania | 19140 | United States |
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| Royal Alexandra Hospital | Not yet recruiting | Edmonton | Alberta | T5H3V9 | Canada |
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| St. Paul's Hospital | Not yet recruiting | Vancouver | British Columbia | Canada |
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| Hamilton Health Sciences Hamilton General Hospital | Recruiting | Hamilton | Ontario | L8L2X2 | Canada |
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| Juravinski Hospital Cancer Centre | Recruiting | Hamilton | Ontario | Canada |
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| St. Joseph's Hospital | Recruiting | Hamilton | Ontario | Canada |
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| Niagara Health - St. Catharines | Recruiting | Niagara | Ontario | L2S 0A9 | Canada |
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| Ottawa General Hospital | Recruiting | Ottawa | Ontario | Canada |
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| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
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| St. Joseph's Health Centre | Not yet recruiting | Toronto | Ontario | Canada |
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| St. Michael's Hospital | Recruiting | Toronto | Ontario | Canada |
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| Universite de Sherbooke | Recruiting | Sherbrooke | Quebec | Canada |
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| Ciusss McQ | Recruiting | Trois-Rivières | Quebec | G9A5C5 | Canada |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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