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- Klinische proef NCT02090868
An Oral Intake Screening Tool for Patients Receiving Non-Invasive Ventilation
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Contacten en locaties
Studie Locaties
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London, Verenigd Koninkrijk
- Imperial College Healthcare NHS Trust
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London, Verenigd Koninkrijk, W2 1NY
- St Marys Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Pre Introduction
Pre tool introduction cohort 22 patient participants who will receive standard care (no patients were recruited)
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Nurses
12 nurse participants who will take part in 2 focus group interviews and a teaching session (6 nurse participants were recruited)
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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)
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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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Mid Arm Circumference Change
Tijdsspanne: Day 1, 3, 7, 14
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Day 1, 3, 7, 14
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Fluid Intake Change
Tijdsspanne: Daily over 14 days
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fluid intake from all sources eg intravenous, nasogastric, oral
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Daily over 14 days
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fluid balance change
Tijdsspanne: daily for 14 days
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fluid intake minus fluid output
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daily for 14 days
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New formation of or worsening of existing pressure sores
Tijdsspanne: daily for 14 days
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daily for 14 days
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new diagnosis of aspiration pneumonia
Tijdsspanne: daily for 14 days
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daily for 14 days
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number of days requiring non-invasive ventilation
Tijdsspanne: 14 days
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14 days
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number of days requiring level 2 care
Tijdsspanne: 14 days
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14 days
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length of hospital stay
Tijdsspanne: 14 days
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14 days
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gary Frost, Imperial College London
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 13IC0065
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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