Ultrasound for Confirmation of Gastric Tube Placement in... | NCT04795895

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No obvious difference of primary outcome was detected when external reviewing

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Oct 1, 2023Actual

Completion Date

Oct 1, 2023Actual

First Submitted Date

Mar 10, 2021

First Submission Date that Met QC Criteria

Mar 10, 2021

First Posted Date

Mar 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2024

Last Update Posted Date

Jul 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology.

Aim: Find the best strategy to confirm gastric tube placement to avoid immediate complication.

Method: A randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. The study will be conducted in one medical ICU with 59 beds at a medical center. The primary outcome is the correct rate as comparing with the chest radiography in each group. Total 190 patients is needed with estimated 10% drop-out rate.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ultrasonography (US)	Experimental		Diagnostic Test: ultrasonography (US)
Standard routine (SR)	Active Comparator		Diagnostic Test: Standard routine (SR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasonography (US)	Diagnostic Test	US evaluation was performed after insertion of the tube via subxiphoid approach for tube passing esophagogastric (EG) junction. The tube insertion procedure will be repeated no more than three attempts if no visualization by US.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correct rate as comparing with the chest radiography in each group		1 day

Secondary Outcomes

Measure	Description	Time Frame
procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical indication of nasogastric tube placement
Age than 20 years old.

Exclusion criteria:

Facial trauma or head-base fractures
Esophageal or gastric resection
Esophageal strictures or alkaline injury
Open wound in the area to prevent ultrasonography

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ying-Chun Chien, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei	Test2	test3	Taiwan

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis