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

NCT03454399 | Completed Results

• 1 other identifier: 11078
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

TEE Image Quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer)

  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)

  6-8 months after initial images obtained during surgery

Study Arms (2)

TEE image before suction

NO INTERVENTION

Suction orogastric tube which is attached to TEE probe

TEE image after suction

EXPERIMENTAL

Suction orogastric tube which is attached to TEE probe

Procedure: Suction orogastric tube which is attached to TEE probe

Interventions

Suction orogastric tube which is attached to TEE probe PROCEDURE

Suction orogastric tube which is attached to TEE probe

TEE image after suction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult cardiac surgery or liver transplant surgery

You may not qualify if:

• TEE with significant wall motion abnormality or TEE contraindicated patients

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

HFHS

Detroit, Michigan, 48202, United States

Location

Results Point of Contact

• Title: Yoshihisa Morita
• Organization: Henry Ford Hospital

YOSHIHISA.MORITA@JEFFERSON.EDU

3059784358

Study Officials

• Donald Penning, MD

  HFHS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: February 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-09

Locations

US (1)