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

NCT ID: NCT03454399

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-12-31

Brief Summary

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.

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.

Conditions

TEE Image Quality

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

TEE image before suction

Suction orogastric tube which is attached to TEE probe

Group Type: NO_INTERVENTION

No interventions assigned to this group

TEE image after suction

Suction orogastric tube which is attached to TEE probe

Group Type: EXPERIMENTAL

Suction orogastric tube which is attached to TEE probe

Intervention Type: PROCEDURE

Suction orogastric tube which is attached to TEE probe

Interventions

Suction orogastric tube which is attached to TEE probe

Suction orogastric tube which is attached to TEE probe

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• adult cardiac surgery or liver transplant surgery

Exclusion Criteria

• TEE with significant wall motion abnormality or TEE contraindicated patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Yoshihisa Morita

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald Penning, MD

Role: STUDY_DIRECTOR

HFHS

Locations

HFHS

Detroit, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

11078

Identifier Type: -

Identifier Source: org_study_id