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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The University of Michigan Medical Center
Ann Arbor, Michigan, United States
Billings Clinic
Billings, Montana, United States
Dartmouth Hitchcock Memorial Hospital
Lebanon, New Hampshire, United States
Columbia University
New York, New York, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Intermountain Medical Center/University of Utah School of Medicine
Salt Lake City, Utah, United States
The University of British Columbia
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Start Date
November 1, 2009
Primary Completion Date
November 1, 2012
Completion Date
November 1, 2012
Last Updated
July 7, 2017
660
ACTUAL participants
Lead Sponsor
Ottawa Hospital Research Institute
Collaborators
NCT07467265
NCT07000526
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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