Trial Outcomes & Findings for On-pump Intraoperative Echocardiography (NCT NCT03094325)
NCT ID: NCT03094325
Last Updated: 2020-03-31
Results Overview
Center tendency parameters(mean, standard deviation)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1 Day
Results posted on
2020-03-31
Participant Flow
All patients, inclusive of male and female and all racial/ethnic origins, age 18 or older who are scheduled to receive a septal myectomy
Participant milestones
| Measure |
All Partcipants
Each of the 10 patients will have 4 measurements(OPIE \& TEE before cardiopulmonary bypass and OPIE \& TEE after cardiopulmonary bypass) in the septum using two techniques (TEE and OPIE Ultrasound Probe).
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
TEE Before Cardiopulmonary Bypass
|
10
|
|
Overall Study
OPIE Before Cardiopulmonary Bypass
|
10
|
|
Overall Study
TEE After Cardiopulmonary Bypass
|
10
|
|
Overall Study
OPIE After Cardiopulmonary Bypass
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
On-pump Intraoperative Echocardiography
Baseline characteristics by cohort
| Measure |
Septal Myectomy
n=10 Participants
Pre Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome.
Pre Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome.
Post Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome.
Post Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 DayCenter tendency parameters(mean, standard deviation)
Outcome measures
| Measure |
TEE Measured Septal Thickness Before Cardiopulmonary Bypass
n=10 Participants
Post Operative Transesophageal echocardiography (TEE) imaging: Center tendency parameters(mean, standard deviation) will be reported for each outcome.
|
OPIE Measured Thickness Before Cardiopulmonary Bypass
n=10 Participants
Post Operative On-pump intraoperative echocardiography: Center tendency parameters(mean, standard deviation) will be reported for each outcome
|
|---|---|---|
|
Septal Thickness Measured Before Cardiopulmonary Bypass
|
22.9 millimeters
Standard Deviation 4.6
|
22.5 millimeters
Standard Deviation 3.5
|
Adverse Events
TEE Measured Septal Thickness Before Cardiopulmonary Bypass
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OPIE Measured Thickness Before Cardiopulmonary Bypass
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