Nasogastric/Orogastric Tube Placement Verification Study Using RightSpot pH Indicator to Verify Gastric Acidity
Small Bowel Obstruction
Device: RightSpot pH Indicator
Radiation: Chest radiograph
|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|
- 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.
- 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.
|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)|
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
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561729
|Contact: Jason Wilson, MD||(813)email@example.com|
|United States, Florida|
|Tampa General Hospital||Recruiting|
|Tampa, Florida, United States, 33606|
|Contact: Jason Wilson, MD 813-627-5937 firstname.lastname@example.org|
|Contact: Jennifer Nilsen, RN (813)844-3162 Jenniferanilsen@tgh.org|
|Principal Investigator:||Jason Wilson, MD||University of South Florida Emergency Medicine Residency Program|