Weaning And Variability Evaluation

NCT01237886 | Completed

• 1 other identifier: 2009-569
• Study Type: observational
• Target: 660
• Locations: 2 countries
• Sites: 14

Brief Summary

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.

Conditions

Mechanically Ventilated Patients; Extubation

Keywords

spontaneous breathing trial; heart rate variability; respiratory rate variability

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (14)

The University of Michigan Medical Center

Ann Arbor, Michigan, 48109-5048, United States

Location

Billings Clinic

Billings, Montana, 59107, United States

Location

Dartmouth Hitchcock Memorial Hospital

Lebanon, New Hampshire, 03756, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6205, United States

Location

Intermountain Medical Center/University of Utah School of Medicine

Salt Lake City, Utah, 84107, United States

Location

The University of British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

The Ottawa Hospital-Civic Campus

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mt Sinai

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 24713049 DERIVED

Study Officials

• Andrew Seely, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: November 10, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

US (7); CA (7)