Carbon Dioxide Partial Pressure Determination, TranscutaneousNCT05640973
TCOM Ring Evaluation
An observational study of Carbon Dioxide Partial Pressure Determination, Transcutaneous, run by Milton S. Hershey Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 minutes to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Carbon Dioxide Partial Pressure Determination, Transcutaneous
- What is being tested?
- Evaluation
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 minutes to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants
Who may be able to join
- 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
Who cannot join
- Absence of written informed consent.
- Skin condition contraindicating transcutaneous measurements.
- Thigh circumference less than or equal to 63 mm
About this study
Official title: Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates
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.
- Being tested
- Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Evaluation of ease of use
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start30 Jun 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Device was FDA approved before feasibility study could be performed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Dioxide Partial Pressure Determination, TranscutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Donnelly, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640973
- Sponsor's protocol ID
- 00020402
- Status last verified
- Sep 2023
- First submitted
- 29 Nov 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates
- ClinicalTrials.gov ID
- NCT05640973
- Acronym / sponsor ID
- 00020402
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Device was FDA approved before feasibility study could be performed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 minutes to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Absence of written informed consent.
- Skin condition contraindicating transcutaneous measurements.
- Thigh circumference less than or equal to 63 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvaluationEvaluation of ease of use | Other | – |
Primary outcome
Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates
Time frame: 3 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Dioxide Partial Pressure Determination, Transcutaneous, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Usability of a Novel Non-Adhesive Applicator for the Monitoring of tcPCO2 in Neonates (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.