Introducing and Evaluating Extubation Advisor

NCT02988167 | Completed

• 1 other identifier: 20160740-01H
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Knowing when to liberate critically ill patients from mechanical ventilation (i.e. extubation) is of great importance as both prolonged ventilation and failed extubation are associated with increased morbidity, mortality \& costs. The study 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.

Conditions

Intubation

Keywords

Spontaneous Breathing Trial (SBT); Extubation Decision Support Tool; Extubation; Extubation Readiness

Outcome Measures

Primary Outcomes (4)

• Introduce Extubation Advisor TM (EA)

  Introduce Extubation Advisor TM (EA) in an observational study in patients being evaluated for extubation, specifically by: (i) engaging RTs to ensure waveform (EKG, CO2) monitoring is in place during spontaneous Breathing Trials (SBTs) and enter clinical data and assessment into the EA data entry screens, (ii) providing RTs and MDs with the EA report at least 48 hours after extubation.

  1 year

• Evaluate Respiratory Therapist (RTs) feedback on the Extubation Advisor TM (EA)

  Evaluate: quality and completeness of data elements and process of data entry, integration with existing RT clinical practice and workflow, time to completion of data entry, 48 hours post extubation/treatment decision obtain RT feedback on quality and overall impression of the report.

  1 year

• Evaluate Intensivist (MD) feedback on the Extubation Advisor TM (EA) Report

  Evaluate quality and completeness of report, ease of integration into existing MD clinical practice and workflow, overall impression and potential impact on decision making.

  1 year

• Evaluate technical feasibility of future real-time implementation of Extubation Advisor TM (EA)

  1 year

Eligibility Criteria

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

Study Population

Patients who are being considered for extubation in the ICU

You may qualify if:

• patients who have been or are expected to be on mechanical ventilation for \> 48 hours in total prior to extubation,
• patients who are ready for Spontaneous Breathing Test (SBT) for assessment for extubation,
• the patients who are able to tolerate pressure support ventilation ≤ 14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP 10 ≤ cm H20,
• patients who are hemodynamically stable (off vasopressors or on low levels of vasopressors: phenylephrine \< 50 ug/min; norepinephrine \< 5 ug/min; dobutamine \< 5 ug/kg/min; milrinone\< 0.4 ug/kg/min),
• patients whose neurological status is stable (no deterioration in the last 24 hrs, intact respiratory drive and ICP \<20),
• patients who have intact airway reflexes (adequate cough with suctioning and a gag reflex), and
• patient who are in normal sinus rhythm at the time of the SBT (no pacemaker).

You may not qualify if:

• patients who have "do not re-intubate" order documented on their chart or if withdrawal of life support is anticipated,
• patients who have a tracheostomy,
• patients who suffer from known or suspected severe myopathy or neuropathy (i.e. myasthenia gravis, Guillain-Barré syndrome) or quadriplegia,
• patients who have been previously extubated during the same ICU admission.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• Sarti AJ, Zheng K, Herry CL, Sutherland S, Scales NB, Watpool I, Porteous R, Hickey M, Anstee C, Fazekas A, Ramsay T, Burns KE, Seely AJ; Canadian Critical Care Trials Group. Feasibility of implementing Extubation Advisor, a clinical decision support tool to improve extubation decision-making in the ICU: a mixed-methods observational study. BMJ Open. 2021 Aug 12;11(8):e045674. doi: 10.1136/bmjopen-2020-045674.

  PMID: 34385234 DERIVED

Study Officials

• Aimee Sarti

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: June 1, 2017
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)