Air Suspension Biodegradable Patient Transport Pad
The Design and Application of Air Suspension Biodegradable Patient Transport Pad
On the one hand, transferring patient from bed to bed is usually handling by the manual lifting of several staffs or utilizing bedsheet, slide sheet , shovel-style stretcher or other devices to move and lift patients. Whatever, there are some advantages using these devices.
On the other hand, nurses are among the professionals at the highest risk for musculoskeletal disorders. The Bureau of Labor Statistics has shown that overexertion in manual lifting was the main event or exposure leading to injury or illness involving time away from work. Excessive weights, awkward postures, and repetitive motions are some of the known risk factors that contribute to sprains/strains and back injuries. During the process of patient transferring , it refers to the above risk factors for health-care workers. It recommended that using appropriate assistive equipment can reduce the injuries. If staff is safe, patients are safer.
The research team has designed and produced a new transport assistive devices-- biodegradable and air-suspending transfer mattress, which was precisely controlled by gas flow and based on ergonomics. And then apply it to the clinic in order to find whether it's benefit for patients and nursing staff.
It is a randomized controlled trial design.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Research design：randomized controlled trials. Computer generated random numbers. The patients were randomly divided into three groups, ① transfer patients by air-suspending mattress, ② transfer patients by slide board, ③ transfer patients by bedsheets.
Participants: passive patient with transports needs, such as CT/ MRI examination etc. The sample size estimation was according to the formula of multiple parallel design. The main outcome measure was the perceived exertion.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Zhejiang
-
Hangzhou, Zhejiang, Porcelana, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Passive patient with transfer requirements, such as CT/ MRI examination , transfer from one department to another etc；Patients or their family signed an informed consent.
Exclusion Criteria:
- The patients weighted over 150kg and have spine fracture ；age< 15 years old.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental group
Patients in experimental group were transferred by air-suspending mattress.
|
Put mattress in advance on the bed.
When patients need to be transferred from bed to bed, fill the mattress with gas and keep it inflated, then pull the mattress .
|
|
Comparador activo: control group 1
Patients in control group 1 were transferred by slide board.
|
When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.
|
|
Comparador activo: control group 2
Patients in control group 2 were transferred by bedsheet.
|
When patients need to be transferred from bed to bed, just lift the bedsheet.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Force value
Periodo de tiempo: Day 1
|
Spring balance was used to measured the pulling force while transferring patients.(Force
value in N)
|
Day 1
|
|
perceived exertion
Periodo de tiempo: Day 1
|
Perceived exertion was evaluated by using the Borg Scale of 6-20, which the values near 6 and 20 represent low and high physical exertion, respectively.（perceived
exertion in scores）
|
Day 1
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
respiration rate
Periodo de tiempo: Day 1（before and after transferring）
|
Be recorded by ECG monitor the moment before and after transferring.（respiration
rate in bpm）
|
Day 1（before and after transferring）
|
|
blood pressure
Periodo de tiempo: Day 1（before and after transferring）
|
Be recorded by ECG monitor the moment before and after transferring.(blood
pressure in mmHg)
|
Day 1（before and after transferring）
|
|
heart rate
Periodo de tiempo: Day 1（before and after transferring）
|
Be recorded by ECG monitor the moment before and after transferring.（heart
rate in bpm）
|
Day 1（before and after transferring）
|
|
oxygen saturation
Periodo de tiempo: Day 1（before and after transferring）
|
Be recorded by ECG monitor the moment before and after transferring.
|
Day 1（before and after transferring）
|
|
Transfer time
Periodo de tiempo: Day 1
|
Stopwatch was used to record the time from using the assistive devices to moving the patients to another bed.（transfer
time in minutes）
|
Day 1
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Satisfaction of patient
Periodo de tiempo: Day 1
|
Self-made satisfaction questionnaire was used to get the patients' satisfaction about the assistive devices after transferring patients.It includes five items about the feelings of assistive devices while moving--comfort, safety, pain, stability and sound.
All the answers take five levels, level five means very satisfied and level one represents very dissatisfied.(Satisfaction of patient in scores)
|
Day 1
|
|
Satisfaction of nurse staff
Periodo de tiempo: Day 1
|
Self-made satisfaction questionnaire was used to get nurse staffs' satisfaction about the assistive devices after transferring patients.
It includes seven items about using the devices to move patients --no adverse events, saving energy, saving time, convenience, applicability, strong support and total satisfaction.
All the answers take five levels, level five means very satisfied and level one represents very dissatisfied.(Satisfaction of patient in scores)
|
Day 1
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Jingfen Jin, Master, The Second Affiliated Hospital of Medical College of Zhejiang University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018PY011
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .