Trial Outcomes & Findings for Does Transesophageal Echocardiography Along With an Orogastric Tube Improve the Image Quality Intraoperatively? (NCT NCT03454399)

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

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.

Results posted on

2024-09-23

Participant Flow

Unit of analysis: image sets

Participant milestones

Participant milestones
Measure	TEE Image Before and After Suctioning Orogastric Tube For intraoperative TEE used cardiac or liver transplant cases. TEE images will be stored before and after suctioning orogastric tube which is attached to TEE probe
TEE Image Before Suction STARTED	47 141
TEE Image Before Suction COMPLETED	47 141
TEE Image Before Suction NOT COMPLETED	0 0
TEE Image After Suction STARTED	47 141
TEE Image After Suction COMPLETED	47 141
TEE Image After Suction NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TEE Image Before and After Suction n=47 Participants Surgeries which need intraoperative TEE (i.e. cardiac surgery and orthotopic liver transplant)
Age, Categorical <=18 years	0 Participants n=47 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=47 Participants
Age, Categorical >=65 years	7 Participants n=47 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 6.9 • n=47 Participants
Sex: Female, Male Female	14 Participants n=47 Participants
Sex: Female, Male Male	33 Participants n=47 Participants
Region of Enrollment United States	47 participants n=47 Participants

PRIMARY outcome

Timeframe: 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.

Population: Surgeries which need intraoperative TEE (cardiac or liver transplant surgery)

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

Outcome measures
Measure	TEE Image Before and After Suction n=141 image sets Suction orogastric tube which is attached to TEE probe
Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning Worse after suction	0 image sets
Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning Improved after suction	79 image sets
Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning Same after suction	62 image sets

SECONDARY outcome

Timeframe: Images are acquired after general anesthesia induction (before suctioning) and after 10min (after suctioning)

Population: Patients who need intraop TEE for cardiac surgery and liver transplant surgery)

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)

Outcome measures

Outcome measures
Measure	TEE Image Before and After Suction n=141 image sets Suction orogastric tube which is attached to TEE probe
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer) intraclass correlation coefficients of LV FAC before suction	0.659 intraclass correlation coefficient Interval 0.511 to 0.78
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer) intraclass correlation coefficients of LV FAC after suction	0.903 intraclass correlation coefficient Interval 0.849 to 0.941

SECONDARY outcome

Timeframe: 6-8 months after initial images obtained during surgery

Population: Patients who need intraop TEE for cardiac surgery and liver transplant 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

Outcome measures

Outcome measures
Measure	TEE Image Before and After Suction n=47 image sets Suction orogastric tube which is attached to TEE probe
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer) intraclass correlation coefficients of LV FAC before suction	0.716 intraclass correlation coefficient Interval 0.536 to 0.833
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer) intraclass correlation coefficients of LV FAC after suction	0.935 intraclass correlation coefficient Interval 0.887 to 0.963

Adverse Events

TEE Related Complications

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

Yoshihisa Morita

Henry Ford Hospital

Phone: 3059784358

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place