Weaning And Variability Evaluation

NCT ID: NCT01237886

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 660 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-11-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Seely, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

The Ottawa Hospital-Civic Campus

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Mt Sinai

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 24713049 (View on PubMed)

Other Identifiers

2009-569

Identifier Type: -

Identifier Source: org_study_id