TCOM Ring Evaluation

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05640973

Enrollment

Registered

2022-12-07

Start date

2023-06-30

Completion date

2023-12-31

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon Dioxide Partial Pressure Determination, Transcutaneous

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.

Interventions

OTHEREvaluation

Evaluation of ease of use

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

5 Minutes to 6 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026