- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Zhejiang
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Hangzhou, Zhejiang, Cina, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Experimental group
Patients in experimental group were 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 .
|
Comparatore attivo: 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.
|
Comparatore attivo: control group 2
Patients in control group 2 were transferred by bedsheet.
|
When patients need to be transferred from bed to bed, just lift the bedsheet.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Force value
Lasso di tempo: Day 1
|
Spring balance was used to measured the pulling force while transferring patients.(Force
value in N)
|
Day 1
|
perceived exertion
Lasso di tempo: 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)
|
Day 1
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
respiration rate
Lasso di tempo: 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
Lasso di tempo: 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)
|
heart rate
Lasso di tempo: 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)
|
oxygen saturation
Lasso di tempo: Day 1(before and after transferring)
|
Be recorded by ECG monitor the moment before and after transferring.
|
Day 1(before and after transferring)
|
Transfer time
Lasso di tempo: 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)
|
Day 1
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Satisfaction of patient
Lasso di tempo: 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
|
Satisfaction of nurse staff
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Jingfen Jin, Master, The Second Affiliated Hospital of Medical College of Zhejiang University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2018PY011
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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