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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01561729
• Other study ID #: Pro00004691
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2012
• Last updated: November 3, 2014
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: RightBio Metrics
• Contact: Jason Wilson, MD
• Phone: (813)627-5931
• Email: tampaerdoc[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

Device:
• RightSpot pH Indicator
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).

Radiation:
• Chest radiograph
Chest radiograph will be taken after tube placement to verify proper positioning of the nasogastric or orogastric tube.

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
RightBio Metrics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes
Secondary	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.	No