Critically IllRELEASENCT02001220
Screening Frequency Trial to Identify Weaning Candidates
A study testing Once daily screening and At least twice daily screening in people with Critically Ill, run by Unity Health Toronto at 8 sites in Canada.
Trial summary
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. 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 and At least twice daily screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 8 sitesCanada
- Study dates
- Jan 2015to Sep 2015
- 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 ≥ 24 hours.
- Capable of initiating spontaneous breaths on PS or triggering breaths on volume or pressure AC, volume or pressure SIMV ± PS, PRVC, or APRV.
- With an FiO2 ≤ 70%.
- With a PEEP ≤ 12 cm H₂O.
- < 65 years of age
Who cannot join
- Patients admitted after cardiopulmonary arrest or with brain death or expected brain death.
- Patients who have evidence of myocardial ischemia in the 24 hour period before enrollment.
- Patients who have received continuous invasive mechanical ventilation for ≥ 2 weeks.
- Patients who have a tracheostomy in situ at the time of screening.
- Patients who are receiving sedative infusions for seizures or alcohol withdrawal.
- Patients who require escalating doses of sedative agents.
Show all 14Show fewer
- Patients who are receiving neuromuscular blockers or who have known quadriplegia, paraplegia, or 4 limb weakness or paralysis preventing active mobilization (e.g. active range of motion, exercises in bed, sitting at edge of bed, transferring from bed to chair, standing, marching in place, ambulating).
- Patients who are moribund (e.g., at imminent risk for death) or who have limitations of treatment (e.g., withdrawal of support, do not reintubate order, however, do not resuscitate orders will be permitted).
- Patients who have profound neurologic deficits (e.g., large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) ≤ 6.
- Patients who are using modes that automate SBT conduct.
- Patients who are currently enrolled in a confounding study that includes a weaning protocol.
- Patients who were previously enrolled in this trial.
- Patients who have already undergone an SBT.
- Patients who have already undergone extubation [planned, unplanned (e.g. self, accidental)] during the same ICU admission.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Hamilton General Hospital
Hamilton, Ontario
St. Joseph's Hospital
Hamilton, Ontario
Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4
Ottawa General Hospital
Ottawa, Ontario
Universite de Sherbrooke
Sherbrooke, Quebec
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario
St Paul's Hospital
Vancouver, British Columbia
About this study
Official title: LibeRation From MEchanicaL VEntilAtion and ScrEening Frequency Trial: The RELEASE Trial
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.
Read the detailed description
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:
- The patient must be capable of initiating spontaneous breaths on Pressure Support (PS) or triggering breaths on volume or pressure Assist Control (AC), volume or pressure Synchronized Intermittent Mandatory Ventilation (SIMV) ± PS, Pressure Regulated Volume Control (PRVC) or Airway Pressure Release Ventilation (APRV),
- The ratio of partial pressure of arterial oxygen to the fractional concentration of inspired oxygen (PaO2/FiO2) greater than or equal to 200 mm Hg,
- Respiratory rate (RR) less than or equal to 35 breaths/min,
- Positive end-expiratory pressure (PEEP) less than or equal to 10 cm H2O,
- Heart rate (HR) less than or equal to 140 beats/min,
- The ratio of respiratory frequency to tidal volume (f/VT) < 105 breaths/min/L during a 2 minute assessment.
- Conditions
- Critically Ill
- Being tested
- Once daily screening, At least twice daily screening
- Keywords
- screening, invasive ventilation, mechanical ventilation, weaning, spontaneous breathing trials
- 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
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.
At least 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. 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.
| Study group | Role | What they receive |
|---|---|---|
| Once daily screening | Active comparator | Patients will undergo assessments to determine readiness to undergo an SBT once daily. Receives: Procedure: Once daily screening |
| At least twice daily screening | Experimental | Patients will undergo assessments to determine readiness to undergo an SBT at least twice daily. Receives: Procedure: At least twice daily screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate our ability to recruit the desired population (1-2 patients, per centre per month, on average)
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
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.
Measured: 2 years
Identify barriers (clinician and institutional) to recruitment
Descriptive
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen EA Burns, MD, FRCPC, Principal investigator, St. Michael's Hospital and the Li Ka Shing Knowledge Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001220
- Sponsor's protocol ID
- 151113
- Acronym
- RELEASE
- Status last verified
- Oct 2017
- First submitted
- 26 Nov 2013
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30920411
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LibeRation From MEchanicaL VEntilAtion and ScrEening Frequency Trial: The RELEASE Trial
- ClinicalTrials.gov ID
- NCT02001220
- Acronym / sponsor ID
- RELEASE / 151113
- Conditions
- Critically Ill
- Keywords
- screening, invasive ventilation, mechanical ventilation, weaning, spontaneous breathing trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Dec 2013 (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.
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.
Detailed description
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:
- The patient must be capable of initiating spontaneous breaths on Pressure Support (PS) or triggering breaths on volume or pressure Assist Control (AC), volume or pressure Synchronized Intermittent Mandatory Ventilation (SIMV) ± PS, Pressure Regulated Volume Control (PRVC) or Airway Pressure Release Ventilation (APRV),
- The ratio of partial pressure of arterial oxygen to the fractional concentration of inspired oxygen (PaO2/FiO2) greater than or equal to 200 mm Hg,
- Respiratory rate (RR) less than or equal to 35 breaths/min,
- Positive end-expiratory pressure (PEEP) less than or equal to 10 cm H2O,
- Heart rate (HR) less than or equal to 140 beats/min,
- The ratio of respiratory frequency to tidal volume (f/VT) < 105 breaths/min/L during a 2 minute assessment.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once daily screening | Active comparator | Procedure: Once daily screeningPatients will undergo assessments to determine readiness to undergo an SBT once daily. |
| At least twice daily screening | Experimental | Procedure: At least twice daily screeningPatients will undergo assessments to determine readiness to undergo an SBT at least twice daily. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Receiving invasive mechanical ventilation for ≥ 24 hours.
- Capable of initiating spontaneous breaths on PS or triggering breaths on volume or pressure AC, volume or pressure SIMV ± PS, PRVC, or APRV.
- With an FiO2 ≤ 70%.
- With a PEEP ≤ 12 cm H₂O.
- < 65 years of age
Key exclusion criteria (14 listed)
- Patients admitted after cardiopulmonary arrest or with brain death or expected brain death.
- Patients who have evidence of myocardial ischemia in the 24 hour period before enrollment.
- Patients who have received continuous invasive mechanical ventilation for ≥ 2 weeks.
- Patients who have a tracheostomy in situ at the time of screening.
- Patients who are receiving sedative infusions 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 screeningIn 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. | Procedure or surgery | Once daily screening |
| At least 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. 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. | Procedure or surgery | At least twice daily screening |
Primary outcome
To demonstrate our ability to recruit the desired population (1-2 patients, per centre per month, on average)
Time frame: 2 years
3 secondary outcomes
To evaluate clinician compliance with 'once daily' versus 'at least twice daily' screening assessments and the potential for contamination in the 'once daily' arm
Time frame: 2 years
Assess current practices related to sedation, analgesia and delirium management and mobilization before conducting 'once daily' or 'at least twice daily screening' assessments
Time frame: 2 years
Identify barriers (clinician and institutional) to recruitment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Derived from this study: PubMed 30920411Burns 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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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 EA Burns, MD, FRCPC principal investigator
St. Michael's Hospital and the Li Ka Shing Knowledge Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Once daily screening and At least twice daily screening in people with Critically Ill, run by Unity Health Toronto at 8 sites in Canada.
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 5 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: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate our ability to recruit the desired population (1-2 patients, per centre per month, on average) (time frame: 2 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 NCT02001220, 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 20 Oct 2017; AzTrials last refreshed its copy on 31 Oct 2026.