Clinical trial NCT01086995: Weaning And Variability Evaluation (WAVE)
Official title: Weaning And Variability Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extubation
Keywords: extubation
weaning
mechanical ventilation
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2010-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) in the intensive care unit.

Brief summary: The purpose of this study is to determine if variability in heart and breathing rates can be used to predict successful weaning. We are collecting data to determine whether or not subtle differences in heart rate and respiratory function will help physicians to decide if a patient is ready to be weaned.

Detailed description: In this prospective observational pilot study, mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) were selected to undergo continuous heart rate (EKG waveform at 500 Hz) and respiratory rate (expired CO2 waveform at 100 Hz) recording. The data was collected as per standard practice by the bedside monitor (Phillips Intelivue MP70). A portable CPU with TrendfaceTM software was used to download the data for variability analysis. All decisions on timing of SBTs and extubation were left to the discretion of the treating team who were unaware of the variability results. SBT's were repeated daily from trial onset until extubation patient permitting.

Eligibility criteria: Inclusion Criteria:

* Patients who have been requiring mechanical ventilation for \>48 hours.
* At least partial reversal of the condition precipitating invasive ventilation.
* Stabilization of "other" organ system failures (i.e. no worsening).
* The patient is able to tolerate pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O)
* The patient is hemodynamically stable (off vasopressors or on low levels of vasopressors).
* Stable neurological status (no deterioration in the last 24 hors, intact respiratory drive and ICP \< 20).
* The patient has intact airway reflexes (adequate cough with suctioning and a gag reflex).

Exclusion Criteria:

* Allergy to skin adhesives or a contraindication to placing electrocardiogram adhesives (e.g. severe psoriasis).
* Do not reintubate order documented on chart or anticipated withdrawal of life support.
* Tracheostomy
* Known or suspected severe myopathy or neuropathy (i.e. myasthenia gravis, Guillain-Barré syndrome) or quadriplegia.
* Severe heart failure or Grade IV left ventricular function.
* Prior extubation during ICU stay.

Primary outcomes:
measure: Continuous heart rate and respiratory rate waveforms
timeFrame: at time of sponataneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital General Campus
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Andrew Seely, MD, PhD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: