Trial Outcomes & Findings for Extubation Advisor: Initial Implementation and Evaluation of a Novel Extubation Clinical Decision Support Tool (NCT NCT04708509)
NCT ID: NCT04708509
Last Updated: 2025-05-15
Results Overview
Feasibility of patient enrolment and consent will be evaluated by determining if greater than 50% of eligible patients are enrolled and consented
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Upon study completion, 4 months after study initiation
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.
Extubation Advisor: Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. Patients will be followed for 72 hours after extubation, when the clinical outcome case report form will be completed.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=30 Participants
Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.
Extubation Advisor: Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. Patients will be followed for 72 hours after extubation, when the clinical outcome case report form will be completed.
|
|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 18.8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Upon study completion, 4 months after study initiationFeasibility of patient enrolment and consent will be evaluated by determining if greater than 50% of eligible patients are enrolled and consented
Outcome measures
| Measure |
Intervention Arm
n=30 Participants
Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.
Extubation Advisor: Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. Patients will be followed for 72 hours after extubation, when the clinical outcome case report form will be completed.
|
|---|---|
|
Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients
|
30 Participants
|
PRIMARY outcome
Timeframe: Upon study completion, 4 months after study initiationFeasibility of wave form data capture will be evaluated by determining if greater than 75% of the time, wave form data is captured
Outcome measures
| Measure |
Intervention Arm
n=70 SBTs
Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.
Extubation Advisor: Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. Patients will be followed for 72 hours after extubation, when the clinical outcome case report form will be completed.
|
|---|---|
|
Evaluate Feasibility of Capturing Greater Than 75% of Wave Form Data
|
68 SBTs
|
PRIMARY outcome
Timeframe: Upon study completion, 4 months after study initiationFeasibility of Extubation Advisor report generation will be evaluated by determining if greater than 80% of the time, an extubation report is successfully generated and delivered to the attending physician
Outcome measures
| Measure |
Intervention Arm
n=70 SBTs initiated
Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.
Extubation Advisor: Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. Patients will be followed for 72 hours after extubation, when the clinical outcome case report form will be completed.
|
|---|---|
|
Evaluate Feasibility of Generating and Delivering Greater Than 80% of Extubation Advisor Reports to the Attending Physician
|
55 EA reports delivered to attending MD
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place