CompletedNot Applicable

Introducing and Evaluating Extubation Advisor

Canada121 participantsStarted 2017-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Introduce Extubation Advisor TM (EA)

Timeframe: 1 year

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

Timeframe: 1 year

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

Timeframe: 1 year

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

Timeframe: 1 year

Trial details

NCT IDNCT02988167

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-10-26

View on ClinicalTrials.gov More Intubation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

What they're measuring

Introduce Extubation Advisor TM (EA)

Timeframe: 1 year

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

Timeframe: 1 year

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

Timeframe: 1 year

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

Timeframe: 1 year

Introducing and Evaluating Extubation Advisor

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Introducing and Evaluating Extubation Advisor

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria