Clinical trial NCT01561729: Nasogastric/Orogastric Tube Placement Verification Study Using RightSpot pH Indicator to Verify Gastric Acidity
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Bowel Obstruction
Gastrointestinal Hemorrhage
Keywords: nasogastric tube
orogastric tube
RightSpot pH Indicator
suction tube
RightBio Metrics
RightLevel
RightSpot Infant
NG Tube
pH
Gastric Acidity
Lead sponsor: RightBio Metrics
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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 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

Primary outcomes:
measure: Determination of proper placement of ng/og tube
timeFrame: 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 outcomes:
measure: Confounding factors for using the RightSpot pH Indicator
timeFrame: 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.
measure: Time to confirmation of tube placement
timeFrame: 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.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida Emergency Medicine Residency Program
name: Jason Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: