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During weaning the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the time on ventilators is spent weaning. Studies support the use of screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to identify weaning candidates. Once daily screening is the current standard of care. With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant opportunity exists to screen patients more frequently, conduct more SBTs, and reduce the time spent on ventilators and in the ICU.
The study is seeking to identify the optimal screening frequency to minimize patients' exposure to invasive ventilation. The RELEASE Trial will evaluate a simple a simple construct: more frequent screening will result In earlier identification of weaning candidates, more frequent SBT's, and less time spent on ventilators and in the ICU. More frequent screening is an appealing intervention because it is sensible, low risk, and represents a cost effective use of current resources. This simple intervention holds promise as a strategy that could change clinical practice, enhance the care delivered to critically ill adults, and improve clinically important outcomes.
Eligible patients (< 65 years of age) will be randomly assigned 1:1 to either 'once daily' or 'at least twice daily' screening for weaning readiness.
After randomization, RTs in participating ICUs will be informed of the allocated study arm and bedside nurses will complete a checklist that documents practices related to sedation, analgesia, delirium, and mobilization before each screening period in both study arms. RTs will conduct weaning readiness assessments either 'once daily' or 'at least twice daily' as per group assignment. The checklists, completed by bedside nurses, will merely record current practices in sedation, analgesia and delirium management, and whether patients are being passively or actively mobilized before SBTs.
In the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. If not yet completed, RTs will prompt RNs to complete the 'practices checklist'. In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 06:00 - 08:00 hours and 13:00 - 15:00 hours 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.
In the event of study inclusion before 10:00 am, both study arms will be initiated on the day of randomization. For patients randomized after 10:00 am, only one assessment will be required in both study arms on day one. Similarly, if patients can breathe spontaneously on PS or trigger spontaneous breaths on volume or pressure AC, volume or pressure SIMV ± PS, PRVC, PAV, VS, or APRV before 10:00 am, then the allocated screening protocol can resume. However if, patients can not be returned to a mode that permits spontaneous breaths (PS) or supports triggered breaths (volume or pressure AC, volume or pressure SIMV ± PS, PRVC, PAV, VS, or APRV) until after 10:00 am, screening will be conducted only once daily in both treatment arms on the day of the return and will resume as per treatment allocation thereafter.
To pass the 'readiness to wean screen' and undergo an SBT, all of the following criteria must be met:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once daily screening | Active Comparator | Patients will undergo assessments to determine readiness to undergo an SBT once daily. |
|
| At least twice daily screening | Experimental | Patients will undergo assessments to determine readiness to undergo an SBT at least twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Once daily screening | Procedure | In the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. The initial SBT will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, CPAP < to 5 cm H2 O or PS < 8 cm H2 O with PEEP < 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and use of different humidification strategies. Each centre will choose one technique to be used for all patients enrolled at their centre. |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate our ability to recruit the desired population (1-2 patients, per centre per month, on average) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate clinician compliance with 'once daily' versus 'at least twice daily' screening assessments and the potential for contamination in the 'once daily' arm | In both arms, compliance rates of at least 80% will be considered acceptable in both arms. A contamination rate of less than or equal to 10% in the once daily screening arm will be acceptable. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Classify trial participants as requiring (i) simple, (ii) difficult or (iii) prolonged weaning using the 'Task Force on Weaning' definitions. | Descriptive | 2 years |
| Obtain preliminary estimates of the impact of the alternative screening strategies ('once daily' vs. 'at least twice daily'') on clinically important outcomes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen EA Burns, MD, FRCPC | St. Michael's Hospital and the Li Ka Shing Knowledge Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Paul's Hospital | Vancouver | British Columbia | Canada | |||
| Hamilton General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30920411 | Derived | Burns KEA, Wong JTY, Dodek P, Cook DJ, Lamontagne F, Cohen A, Mehta S, Kho ME, Hebert PC, Aslanian P, Friedrich JO, Brochard L, Rizvi L, Hand L, Meade MO, Amaral AC, Seely AJ; Canadian Critical Care Trials Group. Frequency of Screening for Weaning From Mechanical Ventilation: Two Contemporaneous Proof-of-Principle Randomized Controlled Trials. Crit Care Med. 2019 Jun;47(6):817-825. doi: 10.1097/CCM.0000000000003722. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2020 | |
| Reset | May 19, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2020 | May 19, 2020 |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| At least 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. Initial SBT will be conducted in the same manner as once daily screening arm. Subsequent SBTs will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, CPAP < to 5 cm H2 O or PS < 8 cm H2 O with PEEP < 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O). Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and use of different humidification strategies. Each centre will be asked to choose one technique to be used for all patients enrolled at their centre. |
|
| Assess current practices related to sedation, analgesia and delirium management and mobilization before conducting 'once daily' or 'at least twice daily screening' assessments | We expect that these practices will be recorded at least 80% of the time, when feasible. Strategies utilized in < 60% of assessments (leading to the first SBT) in either arm will be considered potentially important. | 2 years |
| Identify barriers (clinician and institutional) to recruitment | Descriptive | 2 years |
Clinically important outcomes will include time to first Spontaneous Breathing Trial (SBT) and first successful SBT, time to first extubation and successful extubation, total duration of mechanical ventilation, intensive care unit (ICU) and hospital length of stay, ICU and hospital mortality, use of noninvasive ventilation (NIV) following extubation, complications (self-extubation, tracheostomy, reintubation, proportion requiring prolonged mechanical ventilation)] and adverse events. |
| 2 years |
| Hamilton |
| Ontario |
| Canada |
| St. Joseph's Hospital | Hamilton | Ontario | Canada |
| Ottawa General Hospital | Ottawa | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | Canada |
| Hôpital Saint-Luc | Montreal | Quebec | H2X 3J4 | Canada |
| Universite de Sherbrooke | Sherbrooke | Quebec | Canada |