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Comparison of RightSpot pH Indicator & RightLevel pH Detector With X-Ray Verification for FT or G-Tube Placement

This study has been terminated.
(Insufficient patient population & problems with device use in subjects enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01825564
First Posted: April 5, 2013
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Timothy Havens, MD, St. Louis University
  Purpose
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.

Condition
Gastrostomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the RightSpot pH Indicator & RightLevel pH Detector With the Gold Standard of Radiographic Verification of Feeding Tube Placement & Gastrostomy Tube Replacement

Resource links provided by NLM:


Further study details as provided by Timothy Havens, MD, St. Louis University:

Primary Outcome Measures:
  • pH measurement of gastric or duodenal secretions [ Time Frame: Within 24 hours of tube insertion prior to the initiation of tube feeding ]
    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


Secondary Outcome Measures:
  • Costs associated with G-tube reinsertion in the Emergency Department [ Time Frame: Within 2 weeks of Discharge from the Emergency Department ]
    A collection of all costs related to the Emergency Department visit related to the replacement of the G-tube


Enrollment: 11
Actual Study Start Date: March 14, 2013
Study Completion Date: May 25, 2016
Primary Completion Date: May 25, 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients that are younger than the age of 18
  • Inability to obtain consent
  • Grossly bloody aspirate
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825564


Locations
United States, Missouri
Saint Louis University Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Louis University
Investigators
Principal Investigator: Timothy Havens, MD St. Louis University
  More Information

Responsible Party: Timothy Havens, MD, Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT01825564     History of Changes
Other Study ID Numbers: EZNG-SLU-450126, 22201
First Submitted: February 6, 2013
First Posted: April 5, 2013
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by Timothy Havens, MD, St. Louis University:
G-tube
Feeding tube
Feeding tube placement verification
Enteral feeding