Nasogastric/Orogastric Tube Placement Verification Study Using RightSpot pH Indicator to Verify Gastric Acidity - Full Text View

Purpose

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.

Condition	Intervention
Small Bowel Obstruction Gastrointestinal Hemorrhage	Device: RightSpot pH Indicator Radiation: Chest radiograph


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

Resource links provided by NLM:

MedlinePlus related topics: Gastrointestinal Bleeding

U.S. FDA Resources

Further study details as provided by RightBio Metrics:

Primary Outcome Measures:

Determination of proper placement of ng/og tube [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Confounding factors for using the RightSpot pH Indicator [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
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.
Time to confirmation of tube placement [ Time Frame: 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. ] [ Designated as safety issue: No ]
The time to verification of tube placement will be measured for both chest radiograph and use of RightSpot pH Indicator.


Estimated Enrollment:	30
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Study group 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 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. Other Name: CXR

Arms

Assigned Interventions

Experimental: Study group

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

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.

Other Name: CXR

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561729

Contacts


Contact: Jason Wilson, MD	(813)627-5931	tampaerdoc@gmail.com

Locations


United States, Florida
Tampa General Hospital	Recruiting
Tampa, Florida, United States, 33606
Contact: Jason Wilson, MD 813-627-5937 tampaerdoc@gmail.com
Contact: Jennifer Nilsen, RN (813)844-3162 Jenniferanilsen@tgh.org

Sponsors and Collaborators

RightBio Metrics

Investigators


Principal Investigator:	Jason Wilson, MD	University of South Florida Emergency Medicine Residency Program

More Information


Responsible Party:	RightBio Metrics
ClinicalTrials.gov Identifier:	NCT01561729 History of Changes
Other Study ID Numbers:	Pro00004691
Study First Received:	January 26, 2012
Last Updated:	November 3, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by RightBio Metrics:


nasogastric tube orogastric tube RightSpot pH Indicator suction tube RightBio Metrics	RightLevel RightSpot Infant NG Tube pH Gastric Acidity

Additional relevant MeSH terms:


Hemorrhage Intestinal Obstruction Gastrointestinal Hemorrhage Pathologic Processes	Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on September 23, 2016