Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03454399
Status:
COMPLETED
Last Update Posted:
2018-03-05
First Post:
2018-02-27
Brief Title:
Does Transesophageal Echocardiography Along With an Orogastric Tube Improve the Image Quality Intraoperatively
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Does Transesophageal Echocardiography Along With an Orogastric Tube Improve the Image Quality Intraoperatively
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None