Investigating Fit and Satisfaction of the Prone Positioner

Last updated: January 27, 2025
Sponsor: Children's Mercy Hospital Kansas City
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Prone Positioner

Clinical Study ID

NCT06018064
STUDY00002288
  • Ages 44-24
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Inpatient infants located on the Pediatric Intensive Care Unit (PICU) or (NeonatalIntensive Care Unit (NICU) or being seen in the Vent clinic at Children's Mercy withtracheostomies between the ages of >44 weeks gestational age to 24 months of agewith various size/weights of infants.

  • Any race/ethnicity

  • English speaker

  • Males and females

  • Caregivers

  • Children's Mercy (CM) Occupational Therapists (OTs), Physical Therapists (PTs),Speech Therapists (STs) who have not seen the new prone positioner device.

Exclusion

Exclusion Criteria:

  • Infants > 24 months of age

  • Infants medically unstable as determined by attending physician in the PICU/NICU orVent Clinic

  • Infants with recent cardiac or abdominal surgery who have precautions orcomplications related to their surgery.

  • Infants with weightbearing restrictions/fractures in their upper extremities.

  • Non-English speakers * Wards of the state

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Prone Positioner
Phase:
Study Start date:
September 21, 2023
Estimated Completion Date:
September 30, 2026

Study Description

A trained member of this study staff will be always present in the patient room during the fit test. For the fit test, a therapist from the study team will takes measurements of the infant and then place the infant in the prone positioner device. At no time will the baby be left alone or unsupported by staff. The study team will assess the physical fit, ease of getting the infant in and out of the device, and the patient's tolerance to being in the positioner.

Parents/guardians will be able to be present while the patient is in the device (if the parents are available and present at the time of fit testing) and immediately following the patient's removal from the device, the parents will be asked to complete a paper survey. The survey will ask for their perceptions of the device, initial reactions, and other qualitative data collected during the fit test. Healthcare providers who are not part of the study team will also be surveyed to obtain their thoughts/opinions on the device as well.

Connect with a study center

  • Children's Mercy Kansas City

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.