Critical IllnessNCT03858374
Air Suspension Biodegradable Patient Transport Pad
A study testing transferred by air-suspending mattress, transferred by slide board and transferred by bedsheet in people with Critical Illness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- transferred by air-suspending mattress, transferred by slide board and transferred by bedsheet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The patients weighted over 150kg and have spine fracture ；age< 15 years old.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- transferred by air-suspending mattress, transferred by slide board, transferred by bedsheet
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transferred by air-suspending mattressDevice
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 boardDevice
When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.
transferred by bedsheetDevice
When patients need to be transferred from bed to bed, just lift the bedsheet.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in experimental group were transferred by air-suspending mattress. Receives: Device: transferred by air-suspending mattress |
| control group 1 | Active comparator | Patients in control group 1 were transferred by slide board. Receives: Device: transferred by slide board |
| control group 2 | Active comparator | Patients in control group 2 were transferred by bedsheet. Receives: Device: transferred by bedsheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force value
Spring balance was used to measured the pulling force while transferring patients.(Force value in N)
Measured: 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）
Measured: Day 1
Secondary outcomes (5)
respiration rate
Be recorded by ECG monitor the moment before and after transferring.（respiration rate in bpm）
Measured: Day 1（before and after transferring）
blood pressure
Be recorded by ECG monitor the moment before and after transferring.(blood pressure in mmHg)
Measured: Day 1（before and after transferring）
heart rate
Be recorded by ECG monitor the moment before and after transferring.（heart rate in bpm）
Measured: Day 1（before and after transferring）
oxygen saturation
Be recorded by ECG monitor the moment before and after transferring.
Measured: 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）
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start28 Mar 2018
- Primary completion31 Dec 2019
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jingfen Jin, Master, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858374
- Sponsor's protocol ID
- 2018PY011
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Design and Application of Air Suspension Biodegradable Patient Transport Pad
- ClinicalTrials.gov ID
- NCT03858374
- Acronym / sponsor ID
- 2018PY011
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: transferred by air-suspending mattressPatients in experimental group were transferred by air-suspending mattress. |
| control group 1 | Active comparator | Device: transferred by slide boardPatients in control group 1 were transferred by slide board. |
| control group 2 | Active comparator | Device: transferred by bedsheetPatients in control group 2 were transferred by bedsheet. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The patients weighted over 150kg and have spine fracture ；age< 15 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transferred by air-suspending mattressPut 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 . | Device | Experimental group |
| transferred by slide boardWhen patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board. | Device | control group 1 |
| transferred by bedsheetWhen patients need to be transferred from bed to bed, just lift the bedsheet. | Device | control group 2 |
Primary outcome
Force value
Time frame: Day 1
Spring balance was used to measured the pulling force while transferring patients.(Force value in N)
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）
5 secondary outcomes
respiration rate
Time frame: Day 1（before and after transferring）
blood pressure
Time frame: Day 1（before and after transferring）
heart rate
Time frame: Day 1（before and after transferring）
oxygen saturation
Time frame: Day 1（before and after transferring）
Transfer time
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jingfen Jin, Master principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transferred by air-suspending mattress, transferred by slide board and transferred by bedsheet in people with Critical Illness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force value (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.