Does Transesophageal Echocardiography Along With an Orogastric Tube Improve the Image Quality Intraoperatively?

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.

Study Overview

• Status: Completed
• Conditions: TEE Image Quality
• Intervention / Treatment: Procedure: Suction orogastric tube which is attached to TEE probe

Detailed Description

OGT attached TEE probe is used for cardiac and liver transplantation cases. Each case is assigned 3 investigators who are blinded to this study design, We do image quality assessment by two methods; firstly, we categorize image quality as numbers based on each investigator's impression (1: Very bad, 2: bad, 3: acceptable, 4: good, 5: very good) and compare the difference in number before and after suctioning. Secondly, we evaluate consistency intraclass correlation coefficient (ICC) for inter-observer variability using investigator A, B and C. We evaluate absolute-agreement ICC for intra-observer variability using investigator C, who perform analysis for all images twice with a 6 to 8 months interval. This analysis was performed with left ventricular fraction area change using transgastric left ventricular short axis view.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • HFHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult cardiac surgery or liver transplant surgery

Exclusion Criteria:

• TEE with significant wall motion abnormality or TEE contraindicated patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: TEE image before suction; Suction orogastric tube which is attached to TEE probe
Experimental: TEE image after suction; Suction orogastric tube which is attached to TEE probe	Procedure: Suction orogastric tube which is attached to TEE probe; Suction orogastric tube which is attached to TEE probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning	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)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer)	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)	Images are acquired after general anesthesia induction (before suctioning) and after 10min (after suctioning)
Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer)	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	6-8 months after initial images obtained during surgery

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Study Director: Donald Penning, MD, HFHS

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 11078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No