NCT02279264

Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: RightBio Metrics · Industry
• Sex: All
• Age: 24 Weeks – 40 Weeks
• Healthy volunteers: Not accepted

Summary

Objectives: 1. To validate the accuracy of pH measurements of gastric fluid by comparing the readings from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor 2. To determine what percentage of time the RightSpot Infant pH Indicator could have been used to determine the proper placement of the NG tube prior to feedings 3. To establish normative pH values for neonates

Detailed description

RightBio Metrics has developed an indicator that rapidly checks gastric pH by aspirating gastric contents into the indicator through a nasogastric (NG) or orogastric (OG), causing a color change on the indicator. The color change represents various pH levels. Most Newborn Intensive Care Units require that NG/OG placement be confirmed after initial insertion and prior to any use. The purpose of this study is to validate the accuracy of pH measurement of gastric fluid by comparing the reading from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor, and to determine what percentage of time the RightSpot Infant pH Indicator could have been used to determine the proper placement of the NG/OG tube prior to use. The gastric pH measurements will be analyzed to determine the normative pH values for neonates.

Conditions

• Establish Normative pH Values in Neonates

Interventions

Type	Name	Description
DEVICE	RightSpot Infant pH Indicator	pH indicator

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-11-01
• First posted: 2014-10-31
• Last updated: 2014-10-31

Locations

1 site across 1 country: United States