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An Oral Intake Screening Tool for Patients Receiving Non-Invasive Ventilation

25. august 2020 oppdatert av: Imperial College London

How the Introduction of an Oral Intake Screening Tool Can Benefit Patients Receiving Non-Invasive Ventilation

This study aims to explore how the introduction of an oral intake screening tool can benefit patients requiring noninvasive ventilation. The Quality Care Commission has identified nutritional problems in hospital and there is much literature on the importance of nutrition when critically ill. Literature is short however concerning the specialized population of those requiring noninvasive ventilation and they are a high risk group of suffering from malnutrition.

This study will potentially benefit patients by improving their nutritional care through guided assessment and nurse training.

The study will use mixed methodology, a prospective cohort study and qualitative interviews. The prospective cohort study will collect data from patients prior to the tool introduction, the control group, and post the tool introduction, the exposure group. This will enable comparisons to be made between the exposure and the control groups.

Nurses will be interviewed in semi structured focus groups prior to tool introduction and post to identify themes and sub themes to give a deeper understanding of nutrition in hospital and to examine the use of the tool in practice.

Patients will be eligible if they are over 18 and requiring noninvasive ventilation and nurses will be eligible if they work on the high dependency unit. Patients will be visited daily and have four mid arm circumference measurements at day 1, day 3, day 7 and day 14. The other daily visits will involve collecting data, which is recorded as part of routine care.

Nurses will undergo 2 focus group interviews and a teaching session. The study will take place at St Mary's hospital funded by Imperial College London. The study will be split into two periods with a two week gap in between. Each period will last until 22 patient participants have been recruited.

Studieoversikt

Status

Tilbaketrukket

Intervensjon / Behandling

Detaljert beskrivelse

No patients were recruited to the study due to decreased levels of patients requiring non-invasive ventilation during the study period and time constraints owing to an academic award submission date. Six nurse participants were recruited to the study and underwent two focus group interviews, one prior to tool implementation and one post.

Studietype

Observasjonsmessig

Kontakter og plasseringer

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

Studiesteder

      • London, Storbritannia
        • Imperial College Healthcare NHS Trust
      • London, Storbritannia, W2 1NY
        • St Marys Hospital

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients; Medical High Dependency Unit Patients Staff; Full time employees on the Douglas Acute Admission Unit

Beskrivelse

Patients

Inclusion Criteria:

  • over 18 years old
  • require non-invasive ventilation as defined by the protocol

Exclusion Criteria:

  • Patients on the Liverpool Care Pathway
  • Patients requiring nocturnal non-invasive ventilation only
  • Patients with a tracheostomy
  • Patients with a nasogastric feeding tube insitu on admission
  • Patients with a PEG/RIG tube insitu on admission

Staff

Inclusion Criteria:

  • full time employees
  • work in the medical high dependency unit

Exclusion Criteria:

  • staff only working bank or agency shifts on the medical high dependency unit
  • staff who have not had formal high dependency/critical care training
  • staff who do not work more than 5 shifts per month in the medical high dependency unit
  • staff who have not held a full time post on Douglas Acute Admissions Unit for more than six months

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Pre Introduction
Pre tool introduction cohort 22 patient participants who will receive standard care (no patients were recruited)
Nurses
12 nurse participants who will take part in 2 focus group interviews and a teaching session (6 nurse participants were recruited)
Post Introduction
Pre tool introduction cohort 22 patient participants who's ability to eat and drink orally will be assessed using the Oral Intake Screening Tool (no patient participants were recruited)
A screening tool developed from a literature review and expert opinion. It will be used by nurses to assess patients receiving non-invasive ventilation ability to eat and drink orally and suggest what actions should be taken if they are unable to do so

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Mid Arm Circumference Change
Tidsramme: Day 1, 3, 7, 14
Day 1, 3, 7, 14

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fluid Intake Change
Tidsramme: Daily over 14 days
fluid intake from all sources eg intravenous, nasogastric, oral
Daily over 14 days
fluid balance change
Tidsramme: daily for 14 days
fluid intake minus fluid output
daily for 14 days
New formation of or worsening of existing pressure sores
Tidsramme: daily for 14 days
daily for 14 days
new diagnosis of aspiration pneumonia
Tidsramme: daily for 14 days
daily for 14 days
number of days requiring non-invasive ventilation
Tidsramme: 14 days
14 days
number of days requiring level 2 care
Tidsramme: 14 days
14 days
length of hospital stay
Tidsramme: 14 days
14 days

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Gary Frost, Imperial College London

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)

1. april 2013

Primær fullføring (Faktiske)

1. august 2013

Studiet fullført (Faktiske)

1. august 2013

Datoer for studieregistrering

Først innsendt

2. mai 2013

Først innsendt som oppfylte QC-kriteriene

17. mars 2014

Først lagt ut (Anslag)

18. mars 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2020

Sist bekreftet

1. august 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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