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 range18 Years

SexALL

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
✓. patient who are in normal sinus rhythm at the time of the SBT (no pacemaker).

Exclusion criteria

✕. 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.

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 range18 Years

SexALL

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
✓. patient who are in normal sinus rhythm at the time of the SBT (no pacemaker).

Exclusion criteria

✕. 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.

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