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 |
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.
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.
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
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