TCOM Ring Evaluation

NCT ID: NCT05640973

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Carbon Dioxide Partial Pressure Determination, Transcutaneous

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Evaluation

Evaluation of ease of use

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Minutes

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ann Donnelly

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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00020402

Identifier Type: -

Identifier Source: org_study_id

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