Intubation Clinical Trial
— EAOfficial title:
Introducing and Evaluating Extubation AdvisorTM: A Pilot Phase I Observational Study of a Novel Clinical Decision Support Tool to Improve Extubation Decision-making in the Intensive Care Unit
NCT number | NCT02988167 |
Other study ID # | 20160740-01H |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | October 26, 2018 |
Verified date | March 2019 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 121 |
Est. completion date | October 26, 2018 |
Est. primary completion date | October 26, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. patients who have been or are expected to be on mechanical ventilation for > 48 hours in total prior to extubation, 2. patients who are ready for Spontaneous Breathing Test (SBT) for assessment for extubation, 3. the patients who are able to tolerate pressure support ventilation = 14 cm H2O (SpO2 = 90% with FiO2 = 40% and PEEP 10 = cm H20, 4. 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), 5. patients whose neurological status is stable (no deterioration in the last 24 hrs, intact respiratory drive and ICP <20), 6. patients who have intact airway reflexes (adequate cough with suctioning and a gag reflex), and 7. patient who are in normal sinus rhythm at the time of the SBT (no pacemaker). Exclusion Criteria: 1. patients who have "do not re-intubate" order documented on their chart or if withdrawal of life support is anticipated, 2. patients who have a tracheostomy, 3. patients who suffer from known or suspected severe myopathy or neuropathy (i.e. myasthenia gravis, Guillain-Barré syndrome) or quadriplegia, 4. patients who have been previously extubated during the same ICU admission. |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital General Campus | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Evaluate technical feasibility of future real-time implementation of Extubation Advisor TM (EA) | 1 year |
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