Weaning And Variability Evaluation

Extubation Clinical Trial

— WAVE  

Official title:

Weaning And Variability Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237886
• Other study ID #: 2009-569
• Status: Completed
• Phase: N/A
• First received: October 13, 2010
• Last updated: July 5, 2017
• Start date: November 2009
• Est. completion date: November 2012

Study information

• Verified date: July 2017
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extubation
• Mechanically Ventilated Patients

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	The Ottawa Hospital-Civic Campus	Ottawa	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Mt Sinai	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	The University of British Columbia	Vancouver	British Columbia
United States	The University of Michigan Medical Center	Ann Arbor	Michigan
United States	Billings Clinic	Billings	Montana
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Dartmouth Hitchcock Memorial Hospital	Lebanon	New Hampshire
United States	Columbia University	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Intermountain Medical Center/University of Utah School of Medicine	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)