TCOM Ring Evaluation

NCT05640973 | Withdrawn

• 1 other identifier: 00020402
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carbon Dioxide Partial Pressure Determination, Transcutaneous

Outcome Measures

Primary Outcomes (1)

• Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates

  3 Months

Interventions

Evaluation OTHER

Evaluation of ease of use

Eligibility Criteria

• Age: 5 Minutes - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: June 30, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share