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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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

300

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310009
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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 .
Aktiv komparator: control group 1
Patients in control group 1 were transferred by slide board.
When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.
Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Force value
Tidsramme: Day 1
Spring balance was used to measured the pulling force while transferring patients.(Force value in N)
Day 1
perceived exertion
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
respiration rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Satisfaction of patient
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jingfen Jin, Master, The Second Affiliated Hospital of Medical College of Zhejiang University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. mars 2018

Primær fullføring (Faktiske)

31. desember 2019

Studiet fullført (Forventet)

30. juni 2020

Datoer for studieregistrering

Først innsendt

18. februar 2019

Først innsendt som oppfylte QC-kriteriene

26. februar 2019

Først lagt ut (Faktiske)

28. februar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2018PY011

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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