Weaning And Variability Evaluation (WAVE) (WAVE)

• ClinicalTrials.gov Identifier: NCT01086995
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Last Update Posted: July 7, 2017
• Sponsor: Ottawa Hospital Research Institute
• 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
• 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

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

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