Investigating the Fit and Satisfaction of an Innovative Device - Prone to Excellence: A Tummy Time Device Prone Positioner for Infants With Medical Complexities Including Artificial Airways: A Design Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Fit and Size of Prone Positioner
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 44 Weeks 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Fit and Size of Prone Positioner
时间窗: 45 minutes
Evaluate the fit and size of the prone positioner prototype with infants with tracheostomies of varying ages/sizes
次要结局
- Parental Satisfaction with Prone Positioner(Post patient use of positioner, survey to take a maximum of 10 minutes)
研究者
Brandi Dorton
Principal Investigator
Children's Mercy Hospital Kansas City