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Weaning And Variability Evaluation (WAVE) (WAVE)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 15, 2010
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Weaning And Variability Evaluation

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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) ]

Enrollment: 60
Study Start Date: November 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) in the intensive care unit.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086995

Canada, Ontario
The Ottawa Hospital General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Physicians' Services Incorporated Foundation
Principal Investigator: Andrew Seely, MD, PhD, FRCSC Ottawa Hospital Research Institute
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01086995     History of Changes
Other Study ID Numbers: OH2007-588
First Submitted: March 12, 2010
First Posted: March 15, 2010
Last Update Posted: July 7, 2017
Last Verified: July 2017

Keywords provided by Ottawa Hospital Research Institute:
mechanical ventilation