Clinical trial NCT01237886: Weaning And Variability Evaluation
Official title: Weaning And Variability Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanically Ventilated Patients
Extubation
Keywords: spontaneous breathing trial
heart rate variability
respiratory rate variability
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-11-10
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients

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.


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.

Primary outcomes:
measure: Continuous heart rate (electrocardiogram) & respiratory rate (CO2 capnography) waveforms
timeFrame: at time of spontaneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Medical Center
state: Michigan
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Memorial Hospital
state: New Hampshire
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Intermountain Medical Center/University of Utah School of Medicine
state: Utah
city: Vancouver
country: Canada
facility: The University of British Columbia
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital-Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mt Sinai
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Andrew Seely, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.