Clinical trial NCT03454399: Does Transesophageal Echocardiography Along With an Orogastric Tube Improve the Image Quality Intraoperatively?
Official title: Does Transesophageal Echocardiography Along With an Orogastric Tube Improve the Image Quality Intraoperatively?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TEE Image Quality
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* adult cardiac surgery or liver transplant surgery

Exclusion Criteria:

* TEE with significant wall motion abnormality or TEE contraindicated patients

Primary outcomes:
measure: Image Quality Assessment Method#1: Difference in Likert Scale Before and After Suctioning
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.
Secondary outcomes:
measure: Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Inter-observer)
timeFrame: Images are acquired after general anesthesia induction (before suctioning) and after 10min (after suctioning)
measure: Reproducibility of the Left Ventricular Fraction Area Change (LV FAC) (Intra-observer)
timeFrame: 6-8 months after initial images obtained during surgery
Other outcomes:
Locations:
city: Detroit
country: United States
facility: HFHS
state: Michigan
Study officials:
affiliation: HFHS
name: Donald Penning, MD
role: STUDY_DIRECTOR
References: