Nasogastric/Orogastric Tube Placement Verification Study Using RightSpot pH Indicator to Verify Gastric Acidity

November 3, 2014 updated by: RightBio Metrics

Evaluation of RightBio Metrics', RightSpot pH Indicator, for Rapid Bedside Verification of Proper Nasogastric/ Orogastric Tube Placement in Emergency Department & Intensive Care Unit Patients

This study will evaluate the use of RightBio Metrics' RightSpot device used to determine if there is proper placement of a nasogastric or orogastric tube.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary objective:

To assess the level of accuracy of the RightSpot pH Indicator in determining correct placement of NG/OG tubes as compared to the gold standard of CXR in Emergency Department & ICU patients.

Hypothesis 1: In greater than 90% of the cases, RightSpot pH Indicator will be successful in confirming the placement of NG/OG tubes by demonstrating a pH of 4.5 or less in patients with CXR proven tube placement.

Hypothesis 2: The time to confirmation of NG/OG tube placement will be significantly less using the RightSpot pH Indicator than using CXR. The time will be calculated by the start time consisting of the time that the NG/OG tube was placed until the end time, which will be when the device pH Indicator testing is performed. The time to confirmation using the gold standard of a CXR will begin when the NG/OG tube is placed and end when the CXR is available on PACS (picture archiving and communication system).

Secondary objective:

To determine via subgroup analysis whether gross blood in the stomach, presence of acid-reducing medications, or trauma affects the accuracy of NG/OG placement determination by the RightSpot pH Indicator.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years and older
  • Patient or proxy willing to provide informed consent
  • Patients who require placement of a nasogastric/orogastric tube, in the ED or ICU, as standard of care, AND a member of the study staff is available and present for NG/OG tube placement.
  • It is anticipated that the patient will remain in the ED/ICU in order to obtain RightSpot pH Indicator reading and verifying CXR

Exclusion Criteria:

  • Patients less than 18 years of age
  • Patient or proxy unwilling or unable to provide informed consent
  • Patient with known or suspected pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
This is the only arm of the study. All patients enrolled will have a nasogastric or orogastric tube placed. All will be assessed by both the RightSpot pH Indicator and chest radiograph.
Device: RightSpot pH Indicator
The RightSpot pH Indicator device is used to confirm proper placement of all types of gastric tubes used for gastric rest, suction, or medicating/feeding by measuring the pH of stomach aspirate. This device is intended for 1 (one) SINGLE USE. The probability of proper placement is higher when the pH is less than or equal to 4.5 and if aspirate has a typical gastric fluid appearance (grassy green, brown, colorless- with possible shreds of off-white mucus or sediment).
Radiation: Chest radiograph
Chest radiograph will be taken after tube placement to verify proper positioning of the nasogastric or orogastric tube.
Other Names:
  • CXR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of proper placement of ng/og tube
Time Frame: Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours.
The pH will be assessed by visual inspection of pH paper within the device. If the pH is noted to be less than 4.5 then the placement will be considered to be within the stomach.
Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confounding factors for using the RightSpot pH Indicator
Time Frame: Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours.
A subgroup analysis will be done to determine whether gross blood in the stomach, presence of acid-reducing medications, or trauma affects the accuracy of NG/OG placement determination by the RightSpot pH Indicator.
Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours.
Time to confirmation of tube placement
Time Frame: Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours.
The time to verification of tube placement will be measured for both chest radiograph and use of RightSpot pH Indicator.
Participants will be followed until the determination of proper placement of the ng/og tube is made. This is anticipated to be less than 3 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RightBio Metrics

Investigators

  • Principal Investigator: Jason Wilson, MD, University of South Florida Emergency Medicine Residency Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00004691

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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