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Air Suspension Biodegradable Patient Transport Pad

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ClinicalTrials.gov Identifier: NCT03858374
Recruitment Status : Active, not recruiting
First Posted : February 28, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.


Condition or disease Intervention/treatment Phase
Critical Illness Device: transferred by air-suspending mattress Device: transferred by slide board Device: transferred by bedsheet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Design and Application of Air Suspension Biodegradable Patient Transport Pad
Actual Study Start Date : March 28, 2018
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

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.




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

  2. perceived exertion [ Time Frame: 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)


Secondary Outcome Measures :
  1. respiration rate [ Time Frame: Day 1(before and after transferring) ]
    Be recorded by ECG monitor the moment before and after transferring.(respiration rate in bpm)

  2. blood pressure [ Time Frame: Day 1(before and after transferring) ]
    Be recorded by ECG monitor the moment before and after transferring.(blood pressure in mmHg)

  3. heart rate [ Time Frame: Day 1(before and after transferring) ]
    Be recorded by ECG monitor the moment before and after transferring.(heart rate in bpm)

  4. oxygen saturation [ Time Frame: Day 1(before and after transferring) ]
    Be recorded by ECG monitor the moment before and after transferring.

  5. Transfer time [ Time Frame: 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)


Other Outcome Measures:
  1. Satisfaction of patient [ Time Frame: 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)

  2. Satisfaction of nurse staff [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858374


Locations
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China, Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: jingfen Jin, Master The second affiliated hospital of medical college of zhejiang university
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03858374    
Other Study ID Numbers: 2018PY011
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes