Investigating Fit and Satisfaction of the Prone Positioner

Not Applicable

Recruiting

• Conditions: Infant Development
• Interventions: Device: Prone Positioner

• Registration Number: NCT06018064
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-30
• Study Start: 2023-09-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• 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.
• Non-English speakers * Wards of the state

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Arm	Prone Positioner	Subjects who are placed in the Prone Positioner for evaluation

Primary Outcome Measures

Name	Time	Method
Fit and Size of Prone Positioner	45 minutes	Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes

Secondary Outcome Measures

Name	Time	Method
Parental Satisfaction with Prone Positioner	Post patient use of positioner, survey to take a maximum of 10 minutes	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?)

Trial Locations

Locations (1)

Children's Mercy Kansas City; 🇺🇸 Kansas City, Missouri, United States