Trial Outcomes & Findings for TEE Image Quality Improvement With Our Devised Probe Cover (NCT NCT03812185)
NCT ID: NCT03812185
Last Updated: 2023-12-13
Results Overview
Difference in image quality assessment by Likert scale before/after suctioning, by assessing quality of images stored before/after suctioning. Investigators categorized the quality of all acquired images on a numeric scale (the higher number means higher image quality) based on each investigator's impression (1: very poor, 2: poor, 3: acceptable, 4: good, and 5: very good). Image quality improvement was determined by increased number. Three investigators (A, B, C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. The acquired numeric scales were combined, and compared before and after suctioning, and calculated how much percentage of patients had improved image quality (i.e. increase in numeric scale), same quality (i.e. same numeric scale), and worsened image quality (i.e. decrease in numeric scale)
COMPLETED
NA
53 participants
TEE image sets were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images.
2023-12-13
Participant Flow
3 patients excluded due to resistance to orogastric tube advancement.
Participant milestones
| Measure |
TEE Image Before and After Suctioning Orogastric Tube
for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover.
|
|---|---|
|
TEE Imaging Before Suctioning
STARTED
|
53
|
|
TEE Imaging Before Suctioning
COMPLETED
|
50
|
|
TEE Imaging Before Suctioning
NOT COMPLETED
|
3
|
|
TEE Imaging After Suctioning
STARTED
|
50
|
|
TEE Imaging After Suctioning
COMPLETED
|
50
|
|
TEE Imaging After Suctioning
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
TEE Image Before and After Suctioning Orogastric Tube
for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover.
|
|---|---|
|
TEE Imaging Before Suctioning
Physician Decision
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TEE Image Before and After Suctioning Orogastric Tube
n=50 Participants
for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
61 years
n=50 Participants
|
|
Sex/Gender, Customized
gender not known
|
50 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
PRIMARY outcome
Timeframe: TEE image sets were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images.Difference in image quality assessment by Likert scale before/after suctioning, by assessing quality of images stored before/after suctioning. Investigators categorized the quality of all acquired images on a numeric scale (the higher number means higher image quality) based on each investigator's impression (1: very poor, 2: poor, 3: acceptable, 4: good, and 5: very good). Image quality improvement was determined by increased number. Three investigators (A, B, C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. The acquired numeric scales were combined, and compared before and after suctioning, and calculated how much percentage of patients had improved image quality (i.e. increase in numeric scale), same quality (i.e. same numeric scale), and worsened image quality (i.e. decrease in numeric scale)
Outcome measures
| Measure |
TEE Image Before and After Suctioning Orogastric Tube
n=150 images
for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover. This Arm is TEE image BEFORE suctioning.
Suctioning orogastric tube which is attached to TEE probe cover: Suctioning orogastric tube which is atttached to TEE probe cover.
|
|---|---|
|
Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning
Same after suction
|
65 images
|
|
Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning
Improved after suction
|
83 images
|
|
Image Quality Assessment Method#1: Difference in Likert Scale Before/After Suctioning
Worse after suction
|
2 images
|
SECONDARY outcome
Timeframe: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning images).Population: Inter-observer intraclass correlation coefficients of LV FAC before and after suctioning.
The reproducibility of the LV FAC was assessed, assuming that better image quality would yield better LV FAC reproducibility. Three investigators (A, B, and C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc. These image sets are combined and assessment was done for each group (i.e. before and after suctioning)
Outcome measures
| Measure |
TEE Image Before and After Suctioning Orogastric Tube
n=150 Images
for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover. This Arm is TEE image BEFORE suctioning.
Suctioning orogastric tube which is attached to TEE probe cover: Suctioning orogastric tube which is atttached to TEE probe cover.
|
|---|---|
|
Reproducibility of the LV FAC (Inter-observer)
Intraclass correlation coefficients of LV FAC before suctioning
|
0.94 correlation coefficient
Interval 0.91 to 0.96
|
|
Reproducibility of the LV FAC (Inter-observer)
Intraclass correlation coefficients of LV FAC after suctioning
|
0.99 correlation coefficient
Interval 0.98 to 0.99
|
SECONDARY outcome
Timeframe: 6-8 months after initial images obtained during surgery.Investigator C analyzed all image sets again in 6-8 months to determine if there was intra-observer variability with the initial assessment of image quality. All investigators were blinded to which images were obtained before or after suctioning.
Outcome measures
| Measure |
TEE Image Before and After Suctioning Orogastric Tube
n=50 images
for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover. This Arm is TEE image BEFORE suctioning.
Suctioning orogastric tube which is attached to TEE probe cover: Suctioning orogastric tube which is atttached to TEE probe cover.
|
|---|---|
|
Reproducibility of the LV FAC (Intra-observer)
Intraclass correlation coefficients of LV FAC before suctioning
|
0.95 correlation coefficient
Interval 0.91 to 0.99
|
|
Reproducibility of the LV FAC (Intra-observer)
Intraclass correlation coefficients of LV FAC after suctioning
|
1.00 correlation coefficient
Interval 0.99 to 1.0
|
SECONDARY outcome
Timeframe: Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning).The reproducibility of the RV FAC was assessed, assuming that better image quality would yield better RV FAC reproducibility. Three investigators (A, B, and C) assessed the quality of all TEE image sets (i.e. before and after suctioning) post hoc.
Outcome measures
| Measure |
TEE Image Before and After Suctioning Orogastric Tube
n=150 Images
for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover. This Arm is TEE image BEFORE suctioning.
Suctioning orogastric tube which is attached to TEE probe cover: Suctioning orogastric tube which is atttached to TEE probe cover.
|
|---|---|
|
Reproducibility of the RV FAC (Inter-observer)
Intraclass correlation coefficients of RV FAC before suctioning
|
0.89 correlation coefficient
Interval 0.84 to 0.92
|
|
Reproducibility of the RV FAC (Inter-observer)
Intraclass correlation coefficients of RV FAC after suctioning
|
0.90 correlation coefficient
Interval 0.86 to 0.94
|
SECONDARY outcome
Timeframe: 6-8 months after initial images obtained during surgery.Investigator C analyzed all image sets again in 6-8 months to determine if there was intra-observer variability with the initial assessment of image quality. All investigators were blinded to which images were obtained before or after suctioning.
Outcome measures
| Measure |
TEE Image Before and After Suctioning Orogastric Tube
n=50 Images
for intraoperative TEE used cardiac or transplant cases, TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe cover. This Arm is TEE image BEFORE suctioning.
Suctioning orogastric tube which is attached to TEE probe cover: Suctioning orogastric tube which is atttached to TEE probe cover.
|
|---|---|
|
Reproducibility of the RV FAC (Intra-observer)
Intraclass correlation coefficients of RV FAC before suctioning
|
0.88 correlation coefficient
Interval 0.81 to 0.92
|
|
Reproducibility of the RV FAC (Intra-observer)
Intraclass correlation coefficients of RV FAC after suctioning
|
0.85 correlation coefficient
Interval 0.84 to 0.9
|
Adverse Events
TEE Image Before Suctioning Orogastric Tube
TEE Image After Suctioning Orogastric Tube
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