18 and older, any sex, with TEE Image Quality. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Image Quality Assessment Method#1: Difference in Likert Scale Before and After SuctioningPrimary· TEE image sets were acquired after general anesthesia induction (before suction) and after 10minutes (after suction), and the outcome was the difference in image quality. In 6-8 months, investigator C did the same analysis on the same images in one day.
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,
Improved after suction
Group
Value
95% CI
TEE Image Before and After Suction
79
Same after suction
Group
Value
95% CI
TEE Image Before and After Suction
62
Worse after suction
Group
Value
95% CI
TEE Image Before and After Suction
0
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer)Secondary· Images are acquired after general anesthesia induction (before suctioning) and after 10min (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 tall TEE image sets (i.e. before and after suction) post oc. These image sets were combined, and assessment was done for each group (i.e. before and after suctioning)
intraclass correlation coefficients of LV FAC before suction
Group
Value
95% CI
TEE Image Before and After Suction
0.659
0.511 – 0.78
intraclass correlation coefficients of LV FAC after suction
Group
Value
95% CI
TEE Image Before and After Suction
0.903
0.849 – 0.941
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer)Secondary· 6-8 months after initial images obtained during surgery
Investigator C assess all the image sets in one day again after 6-8 months to determine if there is intra-observer variability with the initial assessment of image quality, All investigators are blinded to which images are obtained before or after suction
intraclass correlation coefficients of LV FAC before suction
Group
Value
95% CI
TEE Image Before and After Suction
0.716
0.536 – 0.833
intraclass correlation coefficients of LV FAC after suction
Group
Value
95% CI
TEE Image Before and After Suction
0.935
0.887 – 0.963
Sponsor's own description
Image quality of intraoperative transesophageal echocardiography (TEE) tends to get worse during long hours of operations. An orogastric tube (OGT) is often inserted in the beginning of the case, and left there for intermittent suction as needed, or removed before TEE exam to prevent echoic artifacts. However, if left there, the effect of suction might be limited due to unreliable tip position of the OG tube. If removed, stomach will be distended again. We devised the OG tube attached TEE for practical suction and assessed its effect on image quality intraoperatively.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Henry Ford Health System
Last refreshed: 23 September 2024
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