Trial Outcomes & Findings for IMMPRES: Intraoperative Monitoring & Management to Reduce Stroke (NCT NCT04543838)
NCT ID: NCT04543838
Last Updated: 2024-11-08
Results Overview
Proportion of patients with a new clinical stroke, new overt stroke, and death will be abstracted from subject EMR.
TERMINATED
NA
19 participants
post-operative day 30
2024-11-08
Participant Flow
Participant milestones
| Measure |
EEG & SSEP Monitoring
Intervention will include standard of care pain management during the postoperative period. Participants in this arm will receive an Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP). EEG will be used to manage blood pressure.
Intervention: Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP) intraoperative monitoring
|
Standard of Care
Control will include standard of care pain management during the postoperative period. Participants in this arm will not receive an Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP).
Standard of Care BP management: If blood pressure (BP) control is determined to be necessary, standard of care practices to manage it will be implemented
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|---|---|---|
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Overall Study
STARTED
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0
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19
|
|
Overall Study
COMPLETED
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0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EEG & SSEP Monitoring
Intervention will include standard of care pain management during the postoperative period. Participants in this arm will receive an Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP). EEG will be used to manage blood pressure.
Intervention: Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP) intraoperative monitoring
|
Standard of Care
n=19 Participants
Control will include standard of care pain management during the postoperative period. Participants in this arm will not receive an Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP).
Standard of Care BP management: If blood pressure (BP) control is determined to be necessary, standard of care practices to manage it will be implemented
|
Total
n=19 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=19 Participants
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0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
|
19 Participants
n=19 Participants
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19 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
|
3 Participants
n=19 Participants
|
3 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
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0 Participants
|
16 Participants
n=19 Participants
|
16 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
United States
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—
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19 participants
n=19 Participants
|
19 participants
n=19 Participants
|
|
Barthel Index
|
—
|
97.37 score on scale
STANDARD_DEVIATION 5.10 • n=19 Participants
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97.37 score on scale
STANDARD_DEVIATION 5.10 • n=19 Participants
|
PRIMARY outcome
Timeframe: post-operative day 30Population: Data not collected due to staffing changes; we have no ability to further ability to collect missing data
Proportion of patients with a new clinical stroke, new overt stroke, and death will be abstracted from subject EMR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-operative 1 yearPopulation: 1-year follow up data was not collected due to staffing changes; we have no ability to further ability to collect missing data
Proportion of patients with cognitive decline will be assessed by observing patients who score up to 2 points or more on the Montreal Cognitive Assessment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-operative 1 yearPopulation: 1-year follow up data was not collected due to staffing changes; we have no ability to further ability to collect missing data
Proportion of patients with transient ischemic attack will be abstracted from subject EMR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-operative 1 yearPopulation: delirium data was not collected due to staffing changes; we have no ability to further ability to collect missing data
Proportion of patients with delirium will be abstracted from subject EMR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-operative 1 yearPopulation: 1-year follow up data was not collected due to staffing changes; we have no ability to further ability to collect missing data
Proportion of patients with clinical stroke will be abstracted from subject EMR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-operative 1 yearPopulation: 1-year follow up data was not collected due to staffing changes; we have no ability to further ability to collect missing data
Proportion of patients with composite of clinical stroke will be abstracted from subject EMR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-operative 1 yearPopulation: 1-year follow up data was not collected due to staffing changes; we have no ability to further ability to collect missing data
Proportion of patients with MACE (death from any cause, non-fatal MI and stroke) will be abstracted from subject EMR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-operative 1 yearPopulation: 1-year follow up data was not collected due to staffing changes; we have no ability to further ability to collect missing data
Proportion of patients with a decrease in quality of life will be assessed by the EuroQol 5-dimension (EQ-5D). The EQ-5D questionnaire consists of two parts. The first part contains the EQ-5D descriptive system, comprising of 5 questions regarding mobility, selfcare, usual activities, pain, and depression (scores range from 0 to 1). The second part is a vertical, visual analogue scale with the end-points of "best imaginable health state" and "worst imaginable health state" (scores range from 0 to 100; higher values are better). scores.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-operative 1 yearPopulation: 1-year follow up data was not collected due to staffing changes; we have no ability to further ability to collect missing data
Proportion of patients with a discrete DWI lesion will be abstracted from subject EMR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: post-operative 1 yearPopulation: 1-year follow up data was not collected due to staffing changes; we have no ability to further ability to collect missing data
Overall volume of DWI lesion burden will be abstracted from subject EMR.
Outcome measures
Outcome data not reported
Adverse Events
EEG & SSEP Monitoring
Standard of Care
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