IntubationEANCT02988167
Introducing and Evaluating Extubation Advisor
An observational study of Intubation, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 26 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are being considered for extubation in the ICU
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
As a standard of care for patients who are intubated in the ICU; to assess ability to be extubated, a Spontaneous Breathing Trial (SBT) is performed, where the level of ventilator support is reduced, and patient's response is observed to predict if they will tolerate extubation.
Spontaneous breathing trials (SBTs) are standard of care in assessing extubation readiness; however, there are no universally accepted guidelines regarding their precise performance and reporting.
Given that health is associated with a high degree of variation of physiologic parameters (e.g. heart and respiratory rate), and illness \& stress are associated with a loss of variability, the investigators have demonstrated that maintaining a high level of heart rate (HRV) and respiratory rate variability (RRV) prior to and throughout the Spontaneous Breathing Trial (SBT) will predict successful extubation, and a reduction in heart rate (HRV) and respiratory rate variability (RRV) predicts extubation failure.
Research to date has already demonstrated the added prognostic value and the investigators have derived a predictive model based on continuous monitoring of respiratory rate variability (RRV). The investigators are now poised to evaluate Extubation Advisor (EA) software with the overall goal to transform monitoring and improve care.
This study is a mixed methods, pilot phase I observational study of the clinical implementation of a novel clinical decision support product, Extubation Advisor.TM In this study the investigators will evaluate the feedback of RTs as well as the feedback of MDs post-treatment (extubation) decision.
Questionnaires will be sent to Respiratory Therapists (RT's) and Medical Doctors (MD's) to solicit feedback on the electronic Spontaneous Breathing Trial (SBT) Case Report Form (CRF) and the Extubation Advisor TM (EA) report. All questionnaires will be answered based on a rating scale of 1-5 where 1 is unacceptable and 5 is excellent.
As this proposed study is observational and has no impact on patient care/outcomes, and to avoid bias associated with requiring consent, the investigators believe this study represents one of the limited circumstances under which waived consent may be permitted.
- Conditions
- Intubation
- Keywords
- Spontaneous Breathing Trial (SBT), Extubation Decision Support Tool, Extubation, Extubation Readiness
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Evaluate technical feasibility of future real-time implementation of Extubation Advisor TM (EA)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start1 Jun 2017
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimee Sarti, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988167
- Sponsor's protocol ID
- 20160740-01H
- Acronym
- EA
- Status last verified
- Mar 2019
- First submitted
- 6 Dec 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34385234
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02988167
- Acronym / sponsor ID
- EA / 20160740-01H
- Conditions
- Intubation
- Keywords
- Spontaneous Breathing Trial (SBT), Extubation Decision Support Tool, Extubation, Extubation Readiness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As a standard of care for patients who are intubated in the ICU; to assess ability to be extubated, a Spontaneous Breathing Trial (SBT) is performed, where the level of ventilator support is reduced, and patient's response is observed to predict if they will tolerate extubation.
Spontaneous breathing trials (SBTs) are standard of care in assessing extubation readiness; however, there are no universally accepted guidelines regarding their precise performance and reporting.
Given that health is associated with a high degree of variation of physiologic parameters (e.g. heart and respiratory rate), and illness \& stress are associated with a loss of variability, the investigators have demonstrated that maintaining a high level of heart rate (HRV) and respiratory rate variability (RRV) prior to and throughout the Spontaneous Breathing Trial (SBT) will predict successful extubation, and a reduction in heart rate (HRV) and respiratory rate variability (RRV) predicts extubation failure.
Research to date has already demonstrated the added prognostic value and the investigators have derived a predictive model based on continuous monitoring of respiratory rate variability (RRV). The investigators are now poised to evaluate Extubation Advisor (EA) software with the overall goal to transform monitoring and improve care.
This study is a mixed methods, pilot phase I observational study of the clinical implementation of a novel clinical decision support product, Extubation Advisor.TM In this study the investigators will evaluate the feedback of RTs as well as the feedback of MDs post-treatment (extubation) decision.
Questionnaires will be sent to Respiratory Therapists (RT's) and Medical Doctors (MD's) to solicit feedback on the electronic Spontaneous Breathing Trial (SBT) Case Report Form (CRF) and the Extubation Advisor TM (EA) report. All questionnaires will be answered based on a rating scale of 1-5 where 1 is unacceptable and 5 is excellent.
As this proposed study is observational and has no impact on patient care/outcomes, and to avoid bias associated with requiring consent, the investigators believe this study represents one of the limited circumstances under which waived consent may be permitted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are being considered for extubation in the ICU
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Introduce Extubation Advisor TM (EA)
Time frame: 1 year
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.
Evaluate Respiratory Therapist (RTs) feedback on the Extubation Advisor TM (EA)
Time frame: 1 year
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.
Evaluate Intensivist (MD) feedback on the Extubation Advisor TM (EA) Report
Time frame: 1 year
Evaluate quality and completeness of report, ease of integration into existing MD clinical practice and workflow, overall impression and potential impact on decision making.
Evaluate technical feasibility of future real-time implementation of Extubation Advisor TM (EA)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 34385234Sarti 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.
- Individual participant dataSharing planned: No
Related trials for Intubation
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Not yet recruiting
OR Video-Laryngoscope Evaluations
Video Laryngoscopy, Quality Improvement
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
Enrolling by invitation
A Study Of T1/Tref Intubating Conditions
Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimee Sarti principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introduce Extubation Advisor TM (EA) (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.