Investigating Fit and Satisfaction of the Prone Positioner
ConditionInfant Development
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age44-24
SponsorChildren's Mercy Hospital Kansas City
About this trial
The goal of this clinical trial is to learn about the use of the Prone Positioner in pediatric patients with tracheostomies (trachs). The main question\[s\] it aims to answer are:
* What is the fit and satisfaction of the device? * Does the device fulfill the goal of allowing infants with trachs participate in tummy time * What aesthetic feedback will the study team receive on the prone positioner from families, therapists, and nursing staff.
Participants will be placed in the Prone Positioner, they will be monitored for their comfort/satisfaction with use, and how well they are able to be receive ventilation while in the device. Parents of these infants, as well as healthcare providers, will be surveyed on thoughts/suggestions for the Prone Positioner.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inpatient infants located on the Pediatric Intensive Care Unit (PICU) or (Neonatal Intensive Care Unit (NICU) or being seen in the Vent clinic at Children's Mercy with tracheostomies between the ages of >44 weeks gestational age to 24 months of age with various size/weights of infants.
Any race/ethnicity
English speaker
Males and females
Disqualifiers
Infants > 24 months of age
Infants medically unstable as determined by attending physician in the PICU/NICU or Vent Clinic
Infants with recent cardiac or abdominal surgery who have precautions or complications related to their surgery.
Infants with weightbearing restrictions/fractures in their upper extremities.
Trial design
Design model
Single group
Treatments tested in this trial
Prone Positioner
DeviceAn innovative device to allow for infants to be supported while in the prone position
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Interventional ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fit and Size of Prone Positioner
Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes
Time frame
45 minutesSecondary outcomes
1
Parental Satisfaction with Prone Positioner
Evaluate if the prone positioner appeals to parents' satisfaction and trust in its use (i.e., does the device fulfill the goal of allowing infants with trachs participate in tummy time?)
Time frame
Post patient use of positioner, survey to take a maximum of 10 minutesOther outcomes
1
Improvement in Positioning Needs of Patients
Evaluate if the current prone positioner design improves positioning needs of patients who have tracheostomies and are ventilator dependent
Time frame
Observed during the 45 min when patient is in Prone Positioner2
Aesthetic and Usability Feedback of Prone Positioner
Gather aesthetic and usability feedback on the prone positioner from families, therapists, and nursing staff
Time frame
Post patient use of positioner, survey to take a maximum of 10 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov