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



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:January 2012
End Date:December 2014
Contact:Jason Wilson, MD
Email:tampaerdoc@gmail.com
Phone:(813)627-5931

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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.

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.

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
We found this trial at
1
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
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