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

Not Applicable

• Conditions: Gastrointestinal Hemorrhage; Small Bowel Obstruction
• Interventions: Device: RightSpot pH Indicator; Radiation: Chest radiograph

• Registration Number: NCT01561729
• Lead Sponsor: RightBio Metrics

Brief Summary

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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-04
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	RightSpot pH Indicator	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.
Study group	Chest radiograph	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.

Primary Outcome Measures

Name	Time	Method
Determination of proper placement of ng/og tube	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.

Secondary Outcome Measures

Name	Time	Method
Time to confirmation of tube placement	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.
Confounding factors for using 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.	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.

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States