Investigating Fit and Satisfaction of the Prone Positioner

Children's Mercy Hospital Kansas City

Status

Enrolling

Conditions

Infant Development

Treatments

Device: Prone Positioner

Study type

Interventional

Funder types

Other

Identifiers

NCT06018064

STUDY00002288

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

44 weeks to 24 months old

Volunteers

No Healthy Volunteers

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