NCT01825564

Brief Summary

Replacing a G tube and placing feeding tubes is standard in the Emergency Department (ED) and ICU, respectively. However placement requires a chest or abdominal x-ray to confirm correct position. The investigators are testing the accuracy of the FDA approved devices RightSpot pH Indicator \& RightLevel pH Detector in determining correct position based upon pH which will then be correlated with the standard of care x-ray.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 14, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

3.2 years

First QC Date

February 6, 2013

Last Update Submit

January 20, 2017

Conditions

Gastrostomy

Keywords

G-tubeFeeding tubeFeeding tube placement verificationEnteral feeding

Outcome Measures

Primary Outcomes (1)

  • pH measurement of gastric or duodenal secretions

    The pH measurement obtained will be used to determine correct placement of the gastric or feeding tube as compared to the gold standard method of X-ray following gastrograffin administration

    Within 24 hours of tube insertion prior to the initiation of tube feeding

Secondary Outcomes (1)

  • Costs associated with G-tube reinsertion in the Emergency Department

    Within 2 weeks of Discharge from the Emergency Department

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from the patients presenting to the Emergency Department for replacement of G-Tube or patients residing in the ICU that require placement of feeding tubes for enteral nutrition.

You may qualify if:

  • Age older than 18
  • Requirement for placement of a feeding tube or a G-tube replacement
  • Patient or proxy able to provide informed consent
  • English proficiency of person providing informed consent

You may not qualify if:

  • Patients that are younger than the age of 18
  • Inability to obtain consent
  • Grossly bloody aspirate
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Study Officials

  • Timothy Havens, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2013

First Posted

April 5, 2013

Study Start

March 14, 2013

Primary Completion

May 25, 2016

Study Completion

May 25, 2016

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

US(1)