Weaning And Variability Evaluation (WAVE)

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01086995
First received: March 12, 2010
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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
Extubation

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) ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01086995     History of Changes
Other Study ID Numbers: OH2007-588
Study First Received: March 12, 2010
Last Updated: April 2, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on April 20, 2014