Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507670
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Point of Care Ultrasound for the Detection of Esophageal Food Bolus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Point of Care Ultrasound for the Detection of Esophageal Food Bolus
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a prospective observational case-control study of adult patients presenting to the WellSpan York Hospital Emergency Department YHED with signs and symptoms of esophageal food or foreign body impaction Point of care ultrasound POCUS will then be performed by a trained emergency physician to collect ultrasound data including the presence or absence of direct visualization food bolusforeign body as well as secondary markers of dilatation such as maximal esophageal area Investigators will also enroll an agesex-matched control group of asymptomatic individuals to establish baseline esophageal measurements
Patients will otherwise receive medical treatment per standard of care Subsequent interventions will also be documented including glucagon carbonated beverages and esophagogastroduodenoscopy EGD If patients remain in the ED and improve without need for EGD they will undergo repeat ultrasound Chart review at 1 month will be performed to establish results of EGD including improvement recurrence or presence of pathologic abnormalities The investigators aim to establish normal and abnormal parameters to aid in the diagnosis of esophageal food impactions to predict need for definitive EGD management
Patients will otherwise receive medical treatment per standard of care Subsequent interventions will also be documented including glucagon carbonated beverages and esophagogastroduodenoscopy EGD If patients remain in the ED and improve without need for EGD they will undergo repeat ultrasound Chart review at 1 month will be performed to establish results of EGD including improvement recurrence or presence of pathologic abnormalities The investigators aim to establish normal and abnormal parameters to aid in the diagnosis of esophageal food impactions to predict need for definitive EGD management
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None