Confirmation of Nasogastric Tube Placement Via Ultrasonog... | NCT00941772

Studies
Confirmation of Nasogastric Tube Placement Via Ultrasonography

NCT00941772

Sponsor

Oklahoma State University Center for Health Sciences

Status

Completed

Last Update Posted

Dec 2, 2010Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Nasogastric Tube Intubation

Interventions

Ultrasonography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jul 6, 2009

First Submission Date that Met QC Criteria

Jul 17, 2009

First Posted Date

Jul 20, 2009Estimated

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

Dec 1, 2010

Last Update Posted Date

Dec 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of the study is to determine if ultrasonography is an adequate means for confirmation of nasogastric tube placement and that ultrasonography is more time efficient than radiography confirming nasogastric tube placement.

Detailed Description

Our current nasogastric tube placement protocol requires confirmation of nasogastric tube placement with plain radiography. Obtaining a plane radiograph in the emergency department can be time consuming and exposes the patient to radiation. Ultrasound is readily available to our physicians and does not expose patients to radiation.

Confirmation of nasogastric tube placement by ultrasonography may provide a faster means of confirmation and expose patients to less radiation.

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

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonography	Other	Verify nasogastric tube placement with ultrasonography and compare its accuracy with plain radiography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ultrasonography is as accurate as plain radiograph in confirming nasogastric tube placement		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or Female Patients 18 years of age or older.
Patients in the emergency department at Oklahoma State University Medical Center that require NG intubation with radiography confirmation.

Exclusion Criteria:

Patients under the age of 18 years of age.
Patients that are prisoners of the State or Government.
Patient is pregnant.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Bryan J Menges, D.O.	Oklahoma State University of Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oklahoma State University Medical Center		Tulsa	Oklahoma	74127	United States

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

Not provided

Browse Branches

Not provided