Clinical trial NCT03858374: Air Suspension Biodegradable Patient Transport Pad
Official title: The Design and Application of Air Suspension Biodegradable Patient Transport Pad
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Force value
timeFrame: Day 1
measure: perceived exertion
timeFrame: Day 1
Secondary outcomes:
measure: respiration rate
timeFrame: Day 1（before and after transferring）
measure: blood pressure
timeFrame: Day 1（before and after transferring）
measure: heart rate
timeFrame: Day 1（before and after transferring）
measure: oxygen saturation
timeFrame: Day 1（before and after transferring）
measure: Transfer time
timeFrame: Day 1
Other outcomes:
measure: Satisfaction of patient
timeFrame: Day 1
measure: Satisfaction of nurse staff
timeFrame: Day 1
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital of Medical College of Zhejiang University
name: jingfen Jin, Master
role: PRINCIPAL_INVESTIGATOR
References: