Mechanically Ventilated PatientsWAVENCT01237886
Weaning And Variability Evaluation
An observational study of Mechanically Ventilated Patients and Extubation, run by Ottawa Hospital Research Institute at 14 sites in 2 countries.
Trial summary
Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or endotracheal tube or extubation) is critically important, as both prolonged ventilation and failed extubation are both associated with harm and risk of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients, Extubation
- How many people
- 660 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Nov 2009to Nov 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients
Who may be able to join
- Invasive mechanical ventilation for >48 hours,
- patient is ready for SBTs for assessment for extubation,
- has a normal sinus rhythm at time of SBT (no pacemaker),
- is tolerating pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O),
- hemodynamically stable (low or no vasopressors), stable neurological status (no deterioration in GCS during prior 24 hours \& ICP < 20),
- intact airway reflexes (cough \& gag).
Who cannot join
- Order not to re-intubate,
- anticipated withdrawal of life support,
- known or suspected severe weakness (myopathy, neuropathy or quadriplegia),
- tracheostomy,
- and prior extubation during ICU stay.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States7 sites
The University of Michigan Medical Center
Ann Arbor, Michigan, 48109-5048
Billings Clinic
Billings, Montana, 59107
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Dartmouth Hitchcock Memorial Hospital
Lebanon, New Hampshire, 03756
Columbia University
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6205
Intermountain Medical Center/University of Utah School of Medicine
Salt Lake City, Utah, 84107
Canada7 sites
London Health Sciences Centre
London, Ontario
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
The Ottawa Hospital-Civic Campus
Ottawa, Ontario
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mt Sinai
Toronto, Ontario
The University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
About this study
Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or endotracheal tube or extubation) is critically important, as both prolonged ventilation and failed extubation are both associated with harm and risk of death. Our objective is to improve the safety of extubation by harnessing hidden information contained in the patterns of variation of heart and respiratory rate measured over intervals-in-time. Currently, to assess a patient's ability to be extubated, a spontaneous breathing trial (SBT) is routinely performed, where the level of ventilator support is reduced, and their response is observed in order to help predict if they will tolerate extubation (i.e. complete removal of ventilator support). Given that health is associated with a high degree of variation of physiologic parameters (e.g. heart and respiratory rate), and illness \& stress are associated with a loss of variability, the investigators aim to uncover the loss of variation as a measure of stress during SBT's. The investigators hypothesize that maintaining stable heart rate and respiratory rate variability (HRV and RRV) throughout the SBT will predict subsequent successful extubation, and conversely, a reduction in either HRV or RRV manifest during a SBT predicts extubation failure. A pilot study has demonstrated feasibility, and compelling preliminary results. A website, centralized data storage and analysis, and a trans-disciplinary team of scientists are in place to definitively test this novel technology. Determination of when to extubate critically ill patients remains a high-stakes clinical challenge; and improved prediction of extubation failure has potential to save lives and reduce costs in critically ill patients.
- Conditions
- Mechanically Ventilated Patients, Extubation
- Keywords
- spontaneous breathing trial, heart rate variability, respiratory rate variability
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous heart rate (electrocardiogram) & respiratory rate (CO2 capnography) waveforms
Measured: at time of spontaneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2012
- Study completionNov 2012
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 Mechanically Ventilated PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Andrew Seely, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237886
- Sponsor's protocol ID
- 2009-569
- Acronym
- WAVE
- Status last verified
- Jul 2017
- First submitted
- 13 Oct 2010
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Seely AJ, Bravi A, Herry C, Green G, Longtin A, Ramsay T, Fergusson D, McIntyre L, Kubelik D, Maziak DE, Ferguson N, Brown SM, Mehta S, Martin C, Rubenfeld G, Jacono FJ, Clifford G, Fazekas A, Marshall J; Canadian Critical Care Trials Group (CCCTG). Do heart and respiratory rate variability improve prediction of extubation outcomes in critically ill patients? Crit Care. 2014 Apr 8;18(2):R65. doi: 10.1186/cc13822.
PubMed 24713049
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning And Variability Evaluation
- ClinicalTrials.gov ID
- NCT01237886
- Acronym / sponsor ID
- WAVE / 2009-569
- Conditions
- Mechanically Ventilated Patients, Extubation
- Keywords
- spontaneous breathing trial, heart rate variability, respiratory rate variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Nov 2010 (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.
Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or endotracheal tube or extubation) is critically important, as both prolonged ventilation and failed extubation are both associated with harm and risk of death. Our objective is to improve the safety of extubation by harnessing hidden information contained in the patterns of variation of heart and respiratory rate measured over intervals-in-time. Currently, to assess a patient's ability to be extubated, a spontaneous breathing trial (SBT) is routinely performed, where the level of ventilator support is reduced, and their response is observed in order to help predict if they will tolerate extubation (i.e. complete removal of ventilator support). Given that health is associated with a high degree of variation of physiologic parameters (e.g. heart and respiratory rate), and illness \& stress are associated with a loss of variability, the investigators aim to uncover the loss of variation as a measure of stress during SBT's. The investigators hypothesize that maintaining stable heart rate and respiratory rate variability (HRV and RRV) throughout the SBT will predict subsequent successful extubation, and conversely, a reduction in either HRV or RRV manifest during a SBT predicts extubation failure. A pilot study has demonstrated feasibility, and compelling preliminary results. A website, centralized data storage and analysis, and a trans-disciplinary team of scientists are in place to definitively test this novel technology. Determination of when to extubate critically ill patients remains a high-stakes clinical challenge; and improved prediction of extubation failure has potential to save lives and reduce costs in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (6 listed)
- Invasive mechanical ventilation for >48 hours,
- patient is ready for SBTs for assessment for extubation,
- has a normal sinus rhythm at time of SBT (no pacemaker),
- is tolerating pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O),
- hemodynamically stable (low or no vasopressors), stable neurological status (no deterioration in GCS during prior 24 hours \& ICP < 20),
Key exclusion criteria (5 listed)
- Order not to re-intubate,
- anticipated withdrawal of life support,
- known or suspected severe weakness (myopathy, neuropathy or quadriplegia),
- tracheostomy,
- and prior extubation during ICU stay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Continuous heart rate (electrocardiogram) & respiratory rate (CO2 capnography) waveforms
Time frame: at time of spontaneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)
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 7 Jul 2017.
- Derived from this study: PubMed 24713049Seely AJ, Bravi A, Herry C, Green G, Longtin A, Ramsay T, Fergusson D, McIntyre L, Kubelik D, Maziak DE, Ferguson N, Brown SM, Mehta S, Martin C, Rubenfeld G, Jacono FJ, Clifford G, Fazekas A, Marshall J; Canadian Critical Care Trials Group (CCCTG). Do heart and respiratory rate variability improve prediction of extubation outcomes in critically ill patients? Crit Care. 2014 Apr 8;18(2):R65. doi: 10.1186/cc13822.
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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.
Andrew Seely, MD principal investigator
Ottawa Hospital Research Institute
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanically Ventilated Patients and Extubation, run by Ottawa Hospital Research Institute at 14 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 6 inclusion and 5 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 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, 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?
Continuous heart rate (electrocardiogram) & respiratory rate (CO2 capnography) waveforms (time frame: at time of spontaneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)). 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 NCT01237886, 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 7 Jul 2017.