Eligibility, any sex, with 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/After SuctioningPrimary· 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,
Improved after suction
Group
Value
95% CI
TEE Image Before and After Suctioning Orogastric Tube
83
Same after suction
Group
Value
95% CI
TEE Image Before and After Suctioning Orogastric Tube
65
Worse after suction
Group
Value
95% CI
TEE Image Before and After Suctioning Orogastric Tube
2
Reproducibility of the LV FAC (Inter-observer)Secondary· Images were acquired after general anesthesia induction (before suctioning) and after 10minutes (after suctioning images).
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)
Intraclass correlation coefficients of LV FAC before suctioning
Group
Value
95% CI
TEE Image Before and After Suctioning Orogastric Tube
0.94
0.91 – 0.96
Intraclass correlation coefficients of LV FAC after suctioning
Group
Value
95% CI
TEE Image Before and After Suctioning Orogastric Tube
0.99
0.98 – 0.99
Reproducibility of the LV FAC (Intra-observer)Secondary· 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.
Intraclass correlation coefficients of LV FAC before suctioning
Group
Value
95% CI
Difference in TEE Imaging Before/After Suctioning at 6 Months After the Surgery
0.95
0.91 – 0.99
Intraclass correlation coefficients of LV FAC after suctioning
Group
Value
95% CI
Difference in TEE Imaging Before/After Suctioning at 6 Months After the Surgery
1.00
0.99 – 1.00
Reproducibility of the RV FAC (Inter-observer)Secondary· 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.
Intraclass correlation coefficients of RV FAC before suctioning
Group
Value
95% CI
Difference in TEE Imaging Before/After Suctioning at 6 Months After the Surgery
0.89
0.84 – 0.92
Intraclass correlation coefficients of RV FAC after suctioning
Group
Value
95% CI
Difference in TEE Imaging Before/After Suctioning at 6 Months After the Surgery
0.90
0.86 – 0.94
Reproducibility of the RV FAC (Intra-observer)Secondary· 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.
Intraclass correlation coefficients of RV FAC before suctioning
Group
Value
95% CI
Difference in TEE Imaging Before/After Suctioning at 6 Months After the Surgery
0.88
0.81 – 0.92
Intraclass correlation coefficients of RV FAC after suctioning
Group
Value
95% CI
Difference in TEE Imaging Before/After Suctioning at 6 Months After the Surgery
0.85
0.84 – 0.9
Sponsor's own description
With using suction tube attached TEE probe cover, we will assess its pinpoint suction capacity on image quality and surgical decision making.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Henry Ford Health System
Last refreshed: 13 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03812185.