Trial Outcomes & Findings for Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study (NCT NCT05415449)
NCT ID: NCT05415449
Last Updated: 2025-11-19
Results Overview
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.
COMPLETED
30 participants
Two weeks from recruitment, plus or minus seven days.
2025-11-19
Participant Flow
Participant milestones
| Measure |
No Groups
As per protocol, there were 30 participants who were enrolled (they were all eligible and consented to the study). During the course of data collection, 6 out of 30 were unenrolled due to failed for follow-up/did not complete the data collection process.
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.
Gus gear protective wearable device: Gus gear protective wearable device for central line.
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|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
No Groups
As per protocol, there were 30 participants who were enrolled (they were all eligible and consented to the study). During the course of data collection, 6 out of 30 were unenrolled due to failed for follow-up/did not complete the data collection process.
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.
Gus gear protective wearable device: Gus gear protective wearable device for central line.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
6 out of 30 were unenrolled
Baseline characteristics by cohort
| Measure |
No Groups
n=30 Participants
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.
Gus gear protective wearable device: Gus gear protective wearable device for central line.
|
|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=24 Participants • 6 out of 30 were unenrolled
|
|
Sex: Female, Male
Male
|
10 Participants
n=24 Participants • 6 out of 30 were unenrolled
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants • 6 out of 30 were unenrolled
|
PRIMARY outcome
Timeframe: Two weeks from recruitment, plus or minus seven days.Population: 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.
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.
Outcome measures
| Measure |
No Groups
n=12 interviews
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.
|
|---|---|
|
Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device
|
12 Interviews
|
PRIMARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Anytime during the study period up to nine months.Satisfaction survey from nurses of Children using the Gus gear vest device
Outcome measures
Outcome data not reported
Adverse Events
No Groups
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place