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Completed

NCT Number: NCT01086995

Weaning And Variability Evaluation (WAVE)

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Continuous heart rate and respiratory rate waveforms

    Time frame: at time of sponataneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Weaning And Variability Evaluation

Acronym: WAVE

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 15, 2010
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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