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Weaning And Variability Evaluation (WAVE) (WAVE)

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ClinicalTrials.gov Identifier: NCT01086995
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief 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.

Condition or disease
Extubation

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
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Weaning And Variability Evaluation
Study Start Date : November 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009



Primary Outcome Measures :
  1. 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) ]


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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.
Criteria

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.

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


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

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

Keywords provided by Ottawa Hospital Research Institute:
extubation
weaning
mechanical ventilation