ExtubationWAVENCT01086995
Weaning And Variability Evaluation (WAVE)
An observational study of Extubation, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to determine if variability in heart and breathing rates can be used to predict successful weaning. We are collecting data to determine whether or not subtle differences in heart rate and respiratory function will help physicians to decide if a patient is ready to be weaned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to May 2009
- 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: Mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) in the intensive care unit.
Who may be able to join
- Patients who have been requiring mechanical ventilation for >48 hours.
- At least partial reversal of the condition precipitating invasive ventilation.
- Stabilization of "other" organ system failures (i.e. no worsening).
- The patient is able to tolerate pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O)
- The patient is hemodynamically stable (off vasopressors or on low levels of vasopressors).
- Stable neurological status (no deterioration in the last 24 hors, intact respiratory drive and ICP < 20).
- The patient has intact airway reflexes (adequate cough with suctioning and a gag reflex).
Who cannot join
- Allergy to skin adhesives or a contraindication to placing electrocardiogram adhesives (e.g. severe psoriasis).
- Do not reintubate order documented on chart or anticipated withdrawal of life support.
- Tracheostomy
- Known or suspected severe myopathy or neuropathy (i.e. myasthenia gravis, Guillain-Barré syndrome) or quadriplegia.
- Severe heart failure or Grade IV left ventricular function.
- Prior extubation during ICU stay.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weaning And Variability Evaluation
The purpose of this study is to determine if variability in heart and breathing rates can be used to predict successful weaning. We are collecting data to determine whether or not subtle differences in heart rate and respiratory function will help physicians to decide if a patient is ready to be weaned.
Read the detailed description
In this prospective observational pilot study, mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) were selected to undergo continuous heart rate (EKG waveform at 500 Hz) and respiratory rate (expired CO2 waveform at 100 Hz) recording. The data was collected as per standard practice by the bedside monitor (Phillips Intelivue MP70). A portable CPU with TrendfaceTM software was used to download the data for variability analysis. All decisions on timing of SBTs and extubation were left to the discretion of the treating team who were unaware of the variability results. SBT's were repeated daily from trial onset until extubation patient permitting.
- Conditions
- Extubation
- Keywords
- extubation, weaning, mechanical ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous heart rate and respiratory rate waveforms
Measured: at time of sponataneous 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 posted15 Mar 2010 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtubationStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Andrew Seely, MD, PhD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086995
- Sponsor's protocol ID
- OH2007-588
- Acronym
- WAVE
- Status last verified
- Jul 2017
- First submitted
- 12 Mar 2010
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
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
- NCT01086995
- Acronym / sponsor ID
- WAVE / OH2007-588
- Conditions
- Extubation
- Keywords
- extubation, weaning, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Mar 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.
The purpose of this study is to determine if variability in heart and breathing rates can be used to predict successful weaning. We are collecting data to determine whether or not subtle differences in heart rate and respiratory function will help physicians to decide if a patient is ready to be weaned.
Detailed description
In this prospective observational pilot study, mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) were selected to undergo continuous heart rate (EKG waveform at 500 Hz) and respiratory rate (expired CO2 waveform at 100 Hz) recording. The data was collected as per standard practice by the bedside monitor (Phillips Intelivue MP70). A portable CPU with TrendfaceTM software was used to download the data for variability analysis. All decisions on timing of SBTs and extubation were left to the discretion of the treating team who were unaware of the variability results. SBT's were repeated daily from trial onset until extubation patient permitting.
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
- Mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) in the intensive care unit.
Key inclusion criteria (7 listed)
- Patients who have been requiring mechanical ventilation for >48 hours.
- At least partial reversal of the condition precipitating invasive ventilation.
- Stabilization of "other" organ system failures (i.e. no worsening).
- The patient is able to tolerate pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O)
- The patient is hemodynamically stable (off vasopressors or on low levels of vasopressors).
Key exclusion criteria (6 listed)
- Allergy to skin adhesives or a contraindication to placing electrocardiogram adhesives (e.g. severe psoriasis).
- Do not reintubate order documented on chart or anticipated withdrawal of life support.
- Tracheostomy
- Known or suspected severe myopathy or neuropathy (i.e. myasthenia gravis, Guillain-Barré syndrome) or quadriplegia.
- Severe heart failure or Grade IV left ventricular function.
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 and respiratory rate waveforms
Time frame: at time of sponataneous 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.
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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, PhD, FRCSC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation, run by Ottawa Hospital Research Institute at 1 site 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 7 inclusion and 6 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 1 site 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?
Continuous heart rate and respiratory rate waveforms (time frame: at time of sponataneous 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?
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.