Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Weaning And Variability Evaluation (WAVE) (WAVE)

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.
 
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

Tracking Information
First Submitted Date March 12, 2010
First Posted Date March 15, 2010
Last Update Posted Date July 7, 2017
Study Start Date November 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2014)
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) ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Weaning And Variability Evaluation (WAVE)
Official Title Weaning And Variability Evaluation
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) in the intensive care unit.
Condition Extubation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 12, 2010)
60
Original Actual Enrollment Same as current
Actual Study Completion Date May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01086995
Other Study ID Numbers OH2007-588
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor Ottawa Hospital Research Institute
Collaborators The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Andrew Seely, MD, PhD, FRCSC Ottawa Hospital Research Institute
PRS Account Ottawa Hospital Research Institute
Verification Date July 2017