Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)

NCT02065661 | Completed

• 1 other identifier: EZ Product Validation Study
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

EZ Holdco Inc. has developed two devices for the measurement of gastric content pH. The devices, EZ-NG and EZ-pH, rapidly check gastric pH by aspirating gastric contents into the device through a nasogastric (NG) tube and causing a color change in the device. The color change is then compared to the reference indicator on the device to determine a pH value of the aspirate. Currently there is no bedside rapid way to check gastric pH that protects the clinician from being exposed to the aspirate.

1. 1.Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe.
2. 2.Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH indicator could have been used to determine proper placement of the NG tube when initially placed.

Conditions

Small Bowel Obstruction; Colectomy; Bowel Surgeries

Outcome Measures

Primary Outcomes (1)

• 1. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe.

  60 min

Secondary Outcomes (1)

• 2. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH indicator could have been used to determine proper placement of the NG tube when initially placed.

  60 min

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consented elective surgical candidates

You may qualify if:

• Consented elective surgical patient

Sponsors & Collaborators

• Florida Hospital Tampa Bay Division: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 19, 2014
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: February 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02