Weaning And Variability Evaluation (WAVE)

Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or endotracheal tube or extubation) is critically important, as both prolonged ventilation and failed extubation are both associated with harm and risk of death. Our objective is to improve the safety of extubation by harnessing hidden information contained in the patterns of variation of heart and respiratory rate measured over intervals-in-time. Currently, to assess a patient's ability to be extubated, a spontaneous breathing trial (SBT) is routinely performed, where the level of ventilator support is reduced, and their response is observed in order to help predict if they will tolerate extubation (i.e. complete removal of ventilator support). Given that health is associated with a high degree of variation of physiologic parameters (e.g. heart and respiratory rate), and illness & stress are associated with a loss of variability, the investigators aim to uncover the loss of variation as a measure of stress during SBT's. The investigators hypothesize that maintaining stable heart rate and respiratory rate variability (HRV and RRV) throughout the SBT will predict subsequent successful extubation, and conversely, a reduction in either HRV or RRV manifest during a SBT predicts extubation failure. A pilot study has demonstrated feasibility, and compelling preliminary results. A website, centralized data storage and analysis, and a trans-disciplinary team of scientists are in place to definitively test this novel technology. Determination of when to extubate critically ill patients remains a high-stakes clinical challenge; and improved prediction of extubation failure has potential to save lives and reduce costs in critically ill patients.

Study Overview

• Status: Completed
• Conditions: Mechanically Ventilated Patients; Extubation

• Study Type: Observational
• Enrollment (Actual): 660

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • The University of British Columbia
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital-Civic Campus
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Mt Sinai
• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5048
      • The University of Michigan Medical Center
  • Montana
    • Billings, Montana, United States, 59107
      • Billings Clinic
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Memorial Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-6205
      • University of Pennsylvania
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Intermountain Medical Center/University of Utah School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patients

Description

Inclusion Criteria:

• Invasive mechanical ventilation for >48 hours,
• patient is ready for SBTs for assessment for extubation,
• has a normal sinus rhythm at time of SBT (no pacemaker),
• is tolerating pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O),
• hemodynamically stable (low or no vasopressors), stable neurological status (no deterioration in GCS during prior 24 hours & ICP < 20),
• intact airway reflexes (cough & gag).

Exclusion Criteria:

• Order not to re-intubate,
• anticipated withdrawal of life support,
• known or suspected severe weakness (myopathy, neuropathy or quadriplegia),
• tracheostomy,
• and prior extubation during ICU stay.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Continuous heart rate (electrocardiogram) & respiratory rate (CO2 capnography) waveforms	at time of spontaneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Andrew Seely, MD, Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• Seely AJ, Bravi A, Herry C, Green G, Longtin A, Ramsay T, Fergusson D, McIntyre L, Kubelik D, Maziak DE, Ferguson N, Brown SM, Mehta S, Martin C, Rubenfeld G, Jacono FJ, Clifford G, Fazekas A, Marshall J; Canadian Critical Care Trials Group (CCCTG). Do heart and respiratory rate variability improve prediction of extubation outcomes in critically ill patients? Crit Care. 2014 Apr 8;18(2):R65. doi: 10.1186/cc13822. Erratum In: Crit Care. 2014;18(6):620.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 10, 2010

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: heart rate variability; spontaneous breathing trial; respiratory rate variability
• Other Study ID Numbers: 2009-569