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

25. august 2020 opdateret af: 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.

Studieoversigt

Status

Trukket tilbage

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • London, Det Forenede Kongerige
        • Imperial College Healthcare NHS Trust
      • London, Det Forenede Kongerige, W2 1NY
        • St Marys Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Gary Frost, Imperial College London

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2013

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

2. maj 2013

Først indsendt, der opfyldte QC-kriterier

17. marts 2014

Først opslået (Skøn)

18. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Patients Requiring Non-invasive Ventilation

Kliniske forsøg med Oral Intake Screening Tool

Abonner