- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03858374
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental group
Patients in experimental group were transferred by air-suspending mattress.
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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 .
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활성 비교기: control group 1
Patients in control group 1 were transferred by slide board.
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When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.
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활성 비교기: control group 2
Patients in control group 2 were transferred by bedsheet.
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When patients need to be transferred from bed to bed, just lift the bedsheet.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Force value
기간: Day 1
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Spring balance was used to measured the pulling force while transferring patients.(Force
value in N)
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Day 1
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perceived exertion
기간: Day 1
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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)
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Day 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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respiration rate
기간: Day 1(before and after transferring)
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Be recorded by ECG monitor the moment before and after transferring.(respiration
rate in bpm)
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Day 1(before and after transferring)
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blood pressure
기간: Day 1(before and after transferring)
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Be recorded by ECG monitor the moment before and after transferring.(blood
pressure in mmHg)
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Day 1(before and after transferring)
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heart rate
기간: Day 1(before and after transferring)
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Be recorded by ECG monitor the moment before and after transferring.(heart
rate in bpm)
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Day 1(before and after transferring)
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oxygen saturation
기간: Day 1(before and after transferring)
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Be recorded by ECG monitor the moment before and after transferring.
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Day 1(before and after transferring)
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Transfer time
기간: Day 1
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Stopwatch was used to record the time from using the assistive devices to moving the patients to another bed.(transfer
time in minutes)
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Day 1
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Satisfaction of patient
기간: Day 1
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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)
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Day 1
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Satisfaction of nurse staff
기간: Day 1
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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)
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Day 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jingfen Jin, Master, The Second Affiliated Hospital of Medical College of Zhejiang University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .