Central LineNCT05415449

Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study

An observational study of Central Line, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. to determine the feasibility of utilizing a wearable device 2. to prospectively measure and evaluate parent and nurse satisfaction with the protective wearable device. This is a sequential, convergent mixed methods study design in which qualitative interview data will be collected first followed by quantitative… Read more about this study

Who is it for?: Ages 0 to 12 years
Conditions the study is for: Central Line
What is being tested?: Gus gear protective wearable device
Type of treatment: Medical device
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 14 Dec 2022to 28 May 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 to 12 years
All sexes
No healthy volunteers
Child

Study population: Patients with CVCs ages 0 to 12 years of age

Who may be able to join

Patients with CVCs ages 0 to 12 years of age
May currently utilizing or historically utilized the interventional wearable protective device
Caregiver or parent available
English and Spanish speaking subjects

Who cannot join

• Females with Tanner 2 breast or greater breast development. Justification: the wearable device will not fit properly to secure the CVC and may increase the risk of complications. If the patient does develop breast during the time of the study, then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. Tanner 2 breast development will be evaluated in the screening process of patients.
Patients in critical care services such as neonates, trauma/ neurology intensive care unit, or cardiac intensive care unit. Justification: These patients are not mobile with their CVC and not the targeted population.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Health
Dallas, Texas, 75235

Other trials in United States

About this study

to determine the feasibility of utilizing a wearable device
to prospectively measure and evaluate parent and nurse satisfaction with the protective wearable device.

This is a sequential, convergent mixed methods study design in which qualitative interview data will be collected first followed by quantitative data.

Scheme and Outcomes: Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study.

Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey.

Note: Vest is a Class I Exempt FDA-registered device.

Conditions: Central Line
Being tested: Gus gear protective wearable device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gus gear protective wearable deviceDevice
Gus gear protective wearable device for central line.

Study groups in NCT05415449
Study group	Role	What they receive
No groups		Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study. Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey. Receives: Device: Gus gear protective wearable device

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device
No. of participants who were interviewed i.e. parents (of children using Gus gear vest) on device. Semi-structured interview guide was used to collect interview from parents. Eligible parents were parents of children between 0-12 years of age using the vest, and Parents should be able to speak English/Spanish. Interviews being qualitative in nature, the criteria to assess feasibility from parents using the vest will be done using transcription and inductive content analysis to find codes and themes from the data provided by the parents during the interview.
Measured: Two weeks from recruitment, plus or minus seven days.
Satisfaction Survey From Parents of Children Using the Gus Gear Vest Device
Every month complete 30-day satisfaction survey for a total of three data collection period
Measured: Every month for a total of three data collection periods up to 3 months. Team will have plus or minus seven-day timeframe around the 30-day window to collect the data.
Satisfaction Survey From Nurses
Satisfaction survey from nurses of Children using the Gus gear vest device
Measured: Anytime during the study period up to nine months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 202228 May 2025

First posted13 Jun 2022
Study start14 Dec 2022
Primary completion28 May 2025
Study completion28 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Central LineStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
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: Other
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05415449
Sponsor's protocol ID: STU-2022-0306
Status last verified: Nov 2025
First submitted: 31 May 2022
Last updated: 19 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study
ClinicalTrials.gov ID: NCT05415449
Acronym / sponsor ID: STU-2022-0306
Conditions: Central Line
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: Gus Gear Inc, Society of Pediatric Nurses
Study start: 14 Dec 2022 (actual)
Primary completion: 28 May 2025 (actual)
Study completion: 28 May 2025 (actual)
First posted: 13 Jun 2022 (actual)
Results: Posted 19 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

to determine the feasibility of utilizing a wearable device
to prospectively measure and evaluate parent and nurse satisfaction with the protective wearable device.

This is a sequential, convergent mixed methods study design in which qualitative interview data will be collected first followed by quantitative data.

Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey.

Note: Vest is a Class I Exempt FDA-registered device.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
No groups	–	Device: Gus gear protective wearable deviceIdentify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study. Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey.

Who may qualify

Ages: 0 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Patients with CVCs ages 0 to 12 years of age

Key inclusion criteria (4 listed)

Patients with CVCs ages 0 to 12 years of age
May currently utilizing or historically utilized the interventional wearable protective device
Caregiver or parent available
English and Spanish speaking subjects

Key exclusion criteria (2 listed)

• Females with Tanner 2 breast or greater breast development. Justification: the wearable device will not fit properly to secure the CVC and may increase the risk of complications. If the patient does develop breast during the time of the study, then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. Tanner 2 breast development will be evaluated in the screening process of patients.

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
Gus gear protective wearable deviceGus gear protective wearable device for central line.	Device	No groups

Primary outcome

Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device
Time frame: Two weeks from recruitment, plus or minus seven days.
No. of participants who were interviewed i.e. parents (of children using Gus gear vest) on device. Semi-structured interview guide was used to collect interview from parents. Eligible parents were parents of children between 0-12 years of age using the vest, and Parents should be able to speak English/Spanish. Interviews being qualitative in nature, the criteria to assess feasibility from parents using the vest will be done using transcription and inductive content analysis to find codes and themes from the data provided by the parents during the interview.
Satisfaction Survey From Parents of Children Using the Gus Gear Vest Device
Time frame: Every month for a total of three data collection periods up to 3 months. Team will have plus or minus seven-day timeframe around the 30-day window to collect the data.
Every month complete 30-day satisfaction survey for a total of three data collection period
Satisfaction Survey From Nurses
Time frame: Anytime during the study period up to nine months.
Satisfaction survey from nurses of Children using the Gus gear vest device

Results and safety

Results posted to the registry on 19 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Groups	30	24

Primary outcome: Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device

Time frame: Two weeks from recruitment, plus or minus seven days.. Number. Unit: Interviews

Measure	No Groups n = 12
Value	12

Population analysed: 30 is the enrolled number for quantitative piece of the study. Being mixed methods in nature in design, this study also has qualitative part. Upon interviewing 12 parents, thematic saturation was achieved to conclude data collection for the qualitative part of the study.

Primary outcome: Satisfaction Survey From Parents of Children Using the Gus Gear Vest Device

Time frame: Every month for a total of three data collection periods up to 3 months. Team will have plus or minus seven-day timeframe around the 30-day window to collect the data.

The sponsor has not posted figures for this outcome.

Primary outcome: Satisfaction Survey From Nurses

Time frame: Anytime during the study period up to nine months.

The sponsor has not posted figures for this outcome.

Adverse events

Time frame: Through study completion, an average of 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Groups	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
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Not yet recruitingPhase 4
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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.

Maria Leal, BSN, RN, CPN principal investigator

Children's Health UTSW

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Central Line, run by University of Texas Southwestern Medical Center at 1 site in United States.

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 2 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: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device (time frame: Two weeks from recruitment, plus or minus seven days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05415449.

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 19 Nov 2025.