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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Small Bowel Obstruction, Gastrointestinal Hemorrhage

Intervention / Treatment
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* Device: RightSpot pH Indicator
* Radiation: Chest radiograph


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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<br>* 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).<br>Radiation: Chest radiograph<br>* Chest radiograph will be taken after tube placement to verify proper positioning of the nasogastric or orogastric tube.<br>* Other names: CXR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of proper placement of ng/og tube | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasogastric tube, orogastric tube, RightSpot pH Indicator, suction tube, RightBio Metrics, RightLevel, RightSpot Infant, NG Tube, pH, Gastric Acidity