- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Zhejiang
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Hangzhou, Zhejiang, Čína, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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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Aktivní komparátor: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Force value
Časové okno: Day 1
|
Spring balance was used to measured the pulling force while transferring patients.(Force
value in N)
|
Day 1
|
perceived exertion
Časové okno: 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)
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Day 1
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
respiration rate
Časové okno: Day 1(before and after transferring)
|
Be recorded by ECG monitor the moment before and after transferring.(respiration
rate in bpm)
|
Day 1(before and after transferring)
|
blood pressure
Časové okno: Day 1(before and after transferring)
|
Be recorded by ECG monitor the moment before and after transferring.(blood
pressure in mmHg)
|
Day 1(before and after transferring)
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heart rate
Časové okno: Day 1(before and after transferring)
|
Be recorded by ECG monitor the moment before and after transferring.(heart
rate in bpm)
|
Day 1(before and after transferring)
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oxygen saturation
Časové okno: 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
Časové okno: 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)
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Day 1
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Satisfaction of patient
Časové okno: 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)
|
Day 1
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Satisfaction of nurse staff
Časové okno: 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)
|
Day 1
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Jingfen Jin, Master, The Second Affiliated Hospital of Medical College of Zhejiang University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2018PY011
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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