- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01086995
Weaning And Variability Evaluation (WAVE) (WAVE)
July 5, 2017 updated by: Ottawa Hospital Research Institute
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital General Campus
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Mechanically ventilated patients weaning or near extubation (i.e.
within 1-5 days) in the intensive care unit.
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
at time of sponataneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrew Seely, MD, PhD, FRCSC, Ottawa Hospital Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
March 12, 2010
First Submitted That Met QC Criteria
March 12, 2010
First Posted (Estimate)
March 15, 2010
Study Record Updates
Last Update Posted (Actual)
July 7, 2017
Last Update Submitted That Met QC Criteria
July 5, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OH2007-588
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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