TCOM Ring Evaluation

Withdrawn

• Conditions: Carbon Dioxide Partial Pressure Determination, Transcutaneous

• Registration Number: NCT05640973
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

Subjects that are currently on a transcutaneous carbon dioxide monitor (TCOM) to monitor the carbon dioxide level in their blood will be placed on an additional TCOM using a non-adhesive sensor application ring instead of the usual adhesive ring to hold the TCOM sensor in place in order to evaluate usability of the non-adhesive applicator.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-07
• Study Start: 2023-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Premature or term birth newborn infants requiring transcutaneous monitoring
2. Thigh circumference of greater than 63mm
3. Weight greater than or equal to 600g
4. Ability of caretaker to understand verbal and written instructions and informed consent

Exclusion Criteria

1. Absence of written informed consent.
2. Skin condition contraindicating transcutaneous measurements.
3. Thigh circumference less than or equal to 63 mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates	3 Months