TCOM Ring Evaluation

Milton S. Hershey Medical Center

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Carbon Dioxide Partial Pressure Determination, Transcutaneous

Interventions

EvaluationOTHER

Evaluation of ease of use

Eligibility

Sex: ALLMin age: 5 MinutesMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 3 Months

Data from ClinicalTrials.gov

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