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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness
• Intervention / Treatment: Device: transferred by air-suspending mattress; Device: transferred by slide board; Device: transferred by bedsheet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Patients in experimental group were transferred by air-suspending mattress.	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 .
Active Comparator: control group 1; Patients in control group 1 were transferred by slide board.	Device: transferred by slide board; When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.
Active Comparator: control group 2; Patients in control group 2 were transferred by bedsheet.	Device: transferred by bedsheet; When patients need to be transferred from bed to bed, just lift the bedsheet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Force value	Spring balance was used to measured the pulling force while transferring patients.(Force value in N)	Day 1
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiration rate	Be recorded by ECG monitor the moment before and after transferring.（respiration rate in bpm）	Day 1（before and after transferring）
blood pressure	Be recorded by ECG monitor the moment before and after transferring.(blood pressure in mmHg)	Day 1（before and after transferring）
heart rate	Be recorded by ECG monitor the moment before and after transferring.（heart rate in bpm）	Day 1（before and after transferring）
oxygen saturation	Be recorded by ECG monitor the moment before and after transferring.	Day 1（before and after transferring）
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jingfen Jin, Master, The Second Affiliated Hospital of Medical College of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2018PY011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No