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Air Suspension Biodegradable Patient Transport Pad

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transferred by air-suspending mattress
transferred by slide board
transferred by bedsheet
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Experimental group

control group 1

control group 2

Arm Description

Patients in experimental group were transferred by air-suspending mattress.

Patients in control group 1 were transferred by slide board.

Patients in control group 2 were transferred by bedsheet.

Outcomes

Primary Outcome Measures

Force value
Spring balance was used to measured the pulling force while transferring patients.(Force value in N)
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)

Secondary Outcome Measures

respiration rate
Be recorded by ECG monitor the moment before and after transferring.(respiration rate in bpm)
blood pressure
Be recorded by ECG monitor the moment before and after transferring.(blood pressure in mmHg)
heart rate
Be recorded by ECG monitor the moment before and after transferring.(heart rate in bpm)
oxygen saturation
Be recorded by ECG monitor the moment 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)

Full Information

First Posted
February 18, 2019
Last Updated
February 11, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03858374
Brief Title
Air Suspension Biodegradable Patient Transport Pad
Official Title
The Design and Application of Air Suspension Biodegradable Patient Transport Pad
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients in experimental group were transferred by air-suspending mattress.
Arm Title
control group 1
Arm Type
Active Comparator
Arm Description
Patients in control group 1 were transferred by slide board.
Arm Title
control group 2
Arm Type
Active Comparator
Arm Description
Patients in control group 2 were transferred by bedsheet.
Intervention Type
Device
Intervention Name(s)
transferred by air-suspending mattress
Intervention Description
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 .
Intervention Type
Device
Intervention Name(s)
transferred by slide board
Intervention Description
When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.
Intervention Type
Device
Intervention Name(s)
transferred by bedsheet
Intervention Description
When patients need to be transferred from bed to bed, just lift the bedsheet.
Primary Outcome Measure Information:
Title
Force value
Description
Spring balance was used to measured the pulling force while transferring patients.(Force value in N)
Time Frame
Day 1
Title
perceived exertion
Description
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)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
respiration rate
Description
Be recorded by ECG monitor the moment before and after transferring.(respiration rate in bpm)
Time Frame
Day 1(before and after transferring)
Title
blood pressure
Description
Be recorded by ECG monitor the moment before and after transferring.(blood pressure in mmHg)
Time Frame
Day 1(before and after transferring)
Title
heart rate
Description
Be recorded by ECG monitor the moment before and after transferring.(heart rate in bpm)
Time Frame
Day 1(before and after transferring)
Title
oxygen saturation
Description
Be recorded by ECG monitor the moment before and after transferring.
Time Frame
Day 1(before and after transferring)
Title
Transfer time
Description
Stopwatch was used to record the time from using the assistive devices to moving the patients to another bed.(transfer time in minutes)
Time Frame
Day 1
Other Pre-specified Outcome Measures:
Title
Satisfaction of patient
Description
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)
Time Frame
Day 1
Title
Satisfaction of nurse staff
Description
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)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jingfen Jin, Master
Organizational Affiliation
The Second Affiliated Hospital of Medical College of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

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Air Suspension Biodegradable Patient Transport Pad

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