Gastrointestinal Hemorrhage Clinical Trial
Official title:
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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