Critically IllPhase 2NCT02243449
Screening Elderly Patients for Weaning
A Phase 2 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 65 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
- 102 participants
- Where
- 8 sitesCanada
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The investigators will include:
- elderly (age >/= 65 years) critically ill adults
- receiving invasive mechanical ventilation for at least 24 hours who can breathe spontaneously on Pressure Support (PS) or trigger 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).
- patients must be receiving </= 70% inspired oxygen
- and a positive end-expiratory pressure of </= 12 cm H2O (Table 2). .
Who cannot join
- The investigators will exclude patients who have already undergone extubation or an SBT, are unlikely to benefit (e.g. moribund, expected brain death), on automated weaning modes, participating in studies with a weaning protocol, and those who can not be optimized with regard to sedation and mobilization.
- Specifically, we will exclude patients:
- admitted after cardiopulmonary arrest or with brain death or expected brain death,
- who have evidence of myocardial ischemia in the 24 hour period before enrollment,
- who have received continuous invasive mechanical ventilation for >/= 2 weeks,
- who have a tracheostomy in situ at the time of screening,
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- who are receiving sedative infusions for seizures or alcohol withdrawal,
- who require escalating doses of sedative agents,
- 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),
- 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),
- who have profound neurologic deficits (e.g. large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) </= 6,
- who are using modes that automate SBT conduct,
- who are current enrolled in a confounding study that includes a weaning protocol,
- who were previously enrolled in this trial,
- patients who have already undergone an SBT or
- 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 Hopitalier de Sherbrooke
Sherbrooke, Quebec
Mount Sinai Hospital
Toronto, Ontario
St. Michael's Hospital
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
About this study
Official title: Screening Elderly PatieNts For InclusiOn in a Weaning Trial: The SENIOR 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. The investigators work demonstrates that once daily screening is the current standard of care. The conduct of daily ward rounds and once daily screening in ICUs is poorly aligned with the rapidly changing clinical status of critically ill patients. With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant opportunity exists to screen patients more often, conduct more SBTs, and reduce the time spent on ventilators and in the ICU. Only one mechanical ventilation trial has focused on the elderly and no trial has evaluated weaning outcomes in the elderly and very elderly which may be influenced by the presence of comorbidities, frailty, malnutrition and treatment limitations.
The investigators propose to conduct a pilot randomized trial in 100 elderly (>/= 65 years) critically ill adults comparing 'once daily' screening to 'at least twice daily' screening in 8 adult ICUs. In the proposed trial, the investigators will (i) evaluate their ability to recruit elderly (>/= 65 years) critically ill patients into a weaning trial and (ii) assess whether protocols can be adhered to similarly between elderly (65 to 80 years) and very elderly (>80 years) trial participants. Moreover, they will also address generalizability issues in the conduct of mechanical ventilation research by evaluating potential biases associated with exclusion criteria and consent between elderly and very elderly patients and obtain preliminary estimates of differences in important clinical outcomes between elderly and very elderly participants.
Read the detailed description
In the context of a multicentre, pilot trial in 100 elderly (>/= 65 years) critically ill adults comparing two strategies to identify weaning candidates ('once daily' vs. 'at least twice daily' screening) in 8 ICUs across Canada, we propose to assess feasibility metrics that reflect our ability to consent, enroll and recruit elderly and very elderly invasively ventilated patients and evaluate adherence to the study protocols in preparation for launching a large scale screening RCT.
- Primary Research Question (i) Can we recruit invasively ventilated elderly (age >/= 65 years) critically ill adults into a weaning trial comparing alternative screening strategies?
- Secondary Research Questions (ii) Can clinicians adhere to the assigned screening protocols in both study arms?
- Tertiary Research Questions (ii) What are the proportions of enrolled elderly and very elderly trial participants? (iii) Are the proportions of consents obtained and declined for trial participation similar between eligible elderly and very elderly trial participants? (iv) What are the rates and reasons for trial exclusion based between eligible elderly and very elderly patients? (v) What effect, in preliminary estimates, do the alternative screening strategies have on clinically important outcomes[e.g., 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] between elderly and very elderly trial participants.
- Quaternary Research Questions (i) Can we assess and quantify current practices related to sedation, analgesia an delirium management and mobilization before conducting 'once daily' or 'at least twice daily screening' assessments of weaning readiness with the goal of quantifying factors that may lead to performance bias in the future, planned, large scale weaning trial. (ii) Can we identify barriers (clinician and institutional) to recruitment into this study? (iii) Can we classify trial participants as requiring (i) simple, (ii) difficult or (iii) prolonged weaning using the 'Task Force on Weaning' definitions.
Hypotheses
We hypothesize that we will achieve our feasibility metrics, specifically, that:
- We will recruit at least 2 elderly critically ill patients, on average, per month per ICU.
- Compliance rates will be at least 80% in both study arms and contamination in the once daily screening arm will be < 10%.
- We expect that we will enroll similar proportions of elderly than very elderly trial participants.
- We anticipate that the proportion of consents obtained will be similar between eligible elderly and very elderly participants, the rate of declined consents will be higher in very elderly trial participants.
- We anticipate that rates of exclusion will be greater for very elderly trial participants due to increased prevalence of comorbid illnesses and treatment limitations.
- We expect that preliminary estimates of the impact of the alternative screening strategies on clinically important outcomes will be similar between elderly and very elderly trial participants.
- Practices in sedation, analgesia, delirium and mobilization will be recorded at least 80% of the time.
- We will identify potentially modifiable clinician and institutional barriers to recruitment.
- Proportions of critically ill adults requiring simple, difficult or prolonged weaning in Canadian ICUs will be similar to those reported in the world literature.
- Conditions
- Critically Ill
- Being tested
- Once daily screening, At least twice daily screening
- Keywords
- mechanical ventilation, weaning, elderly, critically ill, screening, spontaneous breathing trial, invasive ventilation
- 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. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met. The initial SBT will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, continuous positive airway pressure (CPAP) less than or equal to 5 cm H2O or PS less than or equal to 8 cm H2O with PEEP less than or equal to 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 be asked to choose one technique to be used for 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. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met. The initial SBT will be conducted in the same manner as in the once daily screening arm. The 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) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and with the use of different humidification strategies. Each centre will be asked to choose one technique for all patients enrolled at their centre.
| Study group | Role | What they receive |
|---|---|---|
| Once daily screening | Active comparator | In the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 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. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. Receives: Procedure: Once daily screening |
| At least twice daily screening | Experimental | 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 as per protocol. Receives: Procedure: At least twice daily screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruit, on average, 2 elderly invasively ventilated, critically ill patients per ICU per month.
As a feasibility trial, the investigators propose to assess feasibility metrics that reflect their ability to consent, enroll and recruit elderly and very elderly invasively ventilated patients and evaluate adherence to the study protocols in preparation for launching a large scale screening RCT including whether they can recruit invasively ventilated elderly (age >/= 65 years) critically ill adults into a weaning trial comparing the alternative screening strategies.
Measured: 12 months
Secondary outcomes (1)
Adhere to the assigned screening protocols in both study arms.
The investigators will assess whether clinicians can adhere to the assigned screening protocols in both study arms. They will consider compliance rates of at least 80% to be acceptable in both study arms and contamination in the once daily screening arm will be < 10%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 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 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen E. A. Burns, MD, FRCPC, Principal investigator, St. Michael's Hospital (Toronto, Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243449
- Sponsor's protocol ID
- SENIOR0000001
- Other IDs
- ClinicalTrials.gov Identifier:
- Status last verified
- Oct 2017
- First submitted
- 1 Apr 2014
- 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
- Screening Elderly PatieNts For InclusiOn in a Weaning Trial: The SENIOR Trial
- ClinicalTrials.gov ID
- NCT02243449
- Acronym / sponsor ID
- SENIOR0000001
- Conditions
- Critically Ill
- Keywords
- mechanical ventilation, weaning, elderly, critically ill, screening, spontaneous breathing trial, invasive ventilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Sep 2014 (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. The investigators work demonstrates that once daily screening is the current standard of care. The conduct of daily ward rounds and once daily screening in ICUs is poorly aligned with the rapidly changing clinical status of critically ill patients. With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant opportunity exists to screen patients more often, conduct more SBTs, and reduce the time spent on ventilators and in the ICU. Only one mechanical ventilation trial has focused on the elderly and no trial has evaluated weaning outcomes in the elderly and very elderly which may be influenced by the presence of comorbidities, frailty, malnutrition and treatment limitations.
The investigators propose to conduct a pilot randomized trial in 100 elderly (>/= 65 years) critically ill adults comparing 'once daily' screening to 'at least twice daily' screening in 8 adult ICUs. In the proposed trial, the investigators will (i) evaluate their ability to recruit elderly (>/= 65 years) critically ill patients into a weaning trial and (ii) assess whether protocols can be adhered to similarly between elderly (65 to 80 years) and very elderly (>80 years) trial participants. Moreover, they will also address generalizability issues in the conduct of mechanical ventilation research by evaluating potential biases associated with exclusion criteria and consent between elderly and very elderly patients and obtain preliminary estimates of differences in important clinical outcomes between elderly and very elderly participants.
Detailed description
In the context of a multicentre, pilot trial in 100 elderly (>/= 65 years) critically ill adults comparing two strategies to identify weaning candidates ('once daily' vs. 'at least twice daily' screening) in 8 ICUs across Canada, we propose to assess feasibility metrics that reflect our ability to consent, enroll and recruit elderly and very elderly invasively ventilated patients and evaluate adherence to the study protocols in preparation for launching a large scale screening RCT.
- Primary Research Question (i) Can we recruit invasively ventilated elderly (age >/= 65 years) critically ill adults into a weaning trial comparing alternative screening strategies?
- Secondary Research Questions (ii) Can clinicians adhere to the assigned screening protocols in both study arms?
- Tertiary Research Questions (ii) What are the proportions of enrolled elderly and very elderly trial participants? (iii) Are the proportions of consents obtained and declined for trial participation similar between eligible elderly and very elderly trial participants? (iv) What are the rates and reasons for trial exclusion based between eligible elderly and very elderly patients? (v) What effect, in preliminary estimates, do the alternative screening strategies have on clinically important outcomes[e.g., 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] between elderly and very elderly trial participants.
- Quaternary Research Questions (i) Can we assess and quantify current practices related to sedation, analgesia an delirium management and mobilization before conducting 'once daily' or 'at least twice daily screening' assessments of weaning readiness with the goal of quantifying factors that may lead to performance bias in the future, planned, large scale weaning trial. (ii) Can we identify barriers (clinician and institutional) to recruitment into this study? (iii) Can we classify trial participants as requiring (i) simple, (ii) difficult or (iii) prolonged weaning using the 'Task Force on Weaning' definitions.
Hypotheses
We hypothesize that we will achieve our feasibility metrics, specifically, that:
- We will recruit at least 2 elderly critically ill patients, on average, per month per ICU.
- Compliance rates will be at least 80% in both study arms and contamination in the once daily screening arm will be < 10%.
- We expect that we will enroll similar proportions of elderly than very elderly trial participants.
- We anticipate that the proportion of consents obtained will be similar between eligible elderly and very elderly participants, the rate of declined consents will be higher in very elderly trial participants.
- We anticipate that rates of exclusion will be greater for very elderly trial participants due to increased prevalence of comorbid illnesses and treatment limitations.
- We expect that preliminary estimates of the impact of the alternative screening strategies on clinically important outcomes will be similar between elderly and very elderly trial participants.
- Practices in sedation, analgesia, delirium and mobilization will be recorded at least 80% of the time.
- We will identify potentially modifiable clinician and institutional barriers to recruitment.
- Proportions of critically ill adults requiring simple, difficult or prolonged weaning in Canadian ICUs will be similar to those reported in the world literature.
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 screeningIn the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 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. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. |
| At least twice daily screening | Experimental | Procedure: At least twice daily screeningIn 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 as per protocol. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- elderly (age >/= 65 years) critically ill adults
- receiving invasive mechanical ventilation for at least 24 hours who can breathe spontaneously on Pressure Support (PS) or trigger 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).
- patients must be receiving </= 70% inspired oxygen
- and a positive end-expiratory pressure of </= 12 cm H2O (Table 2). .
Key exclusion criteria (16 listed)
- The investigators will exclude patients who have already undergone extubation or an SBT, are unlikely to benefit (e.g. moribund, expected brain death), on automated weaning modes, participating in studies with a weaning protocol, and those who can not be optimized with regard to sedation and mobilization.
- admitted after cardiopulmonary arrest or with brain death or expected brain death,
- who have evidence of myocardial ischemia in the 24 hour period before enrollment,
- who have received continuous invasive mechanical ventilation for >/= 2 weeks,
- who have a tracheostomy in situ at the time of screening,
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. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met. The initial SBT will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, continuous positive airway pressure (CPAP) less than or equal to 5 cm H2O or PS less than or equal to 8 cm H2O with PEEP less than or equal to 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 be asked to choose one technique to be used for 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. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met. The initial SBT will be conducted in the same manner as in the once daily screening arm. The 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) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and with the use of different humidification strategies. Each centre will be asked to choose one technique for all patients enrolled at their centre. | Procedure or surgery | At least twice daily screening |
Primary outcome
Recruit, on average, 2 elderly invasively ventilated, critically ill patients per ICU per month.
Time frame: 12 months
As a feasibility trial, the investigators propose to assess feasibility metrics that reflect their ability to consent, enroll and recruit elderly and very elderly invasively ventilated patients and evaluate adherence to the study protocols in preparation for launching a large scale screening RCT including whether they can recruit invasively ventilated elderly (age >/= 65 years) critically ill adults into a weaning trial comparing the alternative screening strategies.
1 secondary outcome
Adhere to the assigned screening protocols in both study arms.
Time frame: 12 months
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 E. A. Burns, MD, FRCPC principal investigator
St. Michael's Hospital (Toronto, Canada)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 16 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recruit, on average, 2 elderly invasively ventilated, critically ill patients per ICU per month. (time frame: 12 months). 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 NCT02243449, 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.