Weaning And Variability Evaluation (WAVE)

NCT01086995 | Completed

• 1 other identifier: OH2007-588
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Extubation

Keywords

extubation; weaning; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Continuous heart rate and respiratory rate waveforms

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) in the intensive care unit.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Study Officials

• Andrew Seely, MD, PhD, FRCSC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: November 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

CA (1)