Weaning And Variability Evaluation (WAVE)

Extubation Clinical Trial

— WAVE  

Official title:

Weaning And Variability Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086995
• Other study ID #: OH2007-588
• Status: Completed
• Phase: N/A
• First received: March 12, 2010
• Last updated: July 5, 2017
• Start date: November 2007
• Est. completion date: May 2009

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extubation

Locations

Country	Name	City	State
Canada	The Ottawa Hospital General Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)