Air Suspension Biodegradable Patient Transport Pad

Critical Illness Clinical Trial

Official title:

The Design and Application of Air Suspension Biodegradable Patient Transport Pad

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03858374
• Other study ID #: 2018PY011
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• 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 .
• transferred by slide board
When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.
• transferred by bedsheet
When patients need to be transferred from bed to bed, just lift the bedsheet.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction of patient	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
Other	Satisfaction of nurse staff	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
Primary	Force value	Spring balance was used to measured the pulling force while transferring patients.(Force value in N)	Day 1
Primary	perceived exertion	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
Secondary	respiration rate	Be recorded by ECG monitor the moment before and after transferring.(respiration rate in bpm)	Day 1(before and after transferring)
Secondary	blood pressure	Be recorded by ECG monitor the moment before and after transferring.(blood pressure in mmHg)	Day 1(before and after transferring)
Secondary	heart rate	Be recorded by ECG monitor the moment before and after transferring.(heart rate in bpm)	Day 1(before and after transferring)
Secondary	oxygen saturation	Be recorded by ECG monitor the moment before and after transferring.	Day 1(before and after transferring)
Secondary	Transfer time	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