- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Kontakter och platser
Studieorter
-
-
-
London, Storbritannien
- Imperial College Healthcare NHS Trust
-
London, Storbritannien, W2 1NY
- St Marys Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Mid Arm Circumference Change
Tidsram: Day 1, 3, 7, 14
|
Day 1, 3, 7, 14
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fluid Intake Change
Tidsram: Daily over 14 days
|
fluid intake from all sources eg intravenous, nasogastric, oral
|
Daily over 14 days
|
|
fluid balance change
Tidsram: daily for 14 days
|
fluid intake minus fluid output
|
daily for 14 days
|
|
New formation of or worsening of existing pressure sores
Tidsram: daily for 14 days
|
daily for 14 days
|
|
|
new diagnosis of aspiration pneumonia
Tidsram: daily for 14 days
|
daily for 14 days
|
|
|
number of days requiring non-invasive ventilation
Tidsram: 14 days
|
14 days
|
|
|
number of days requiring level 2 care
Tidsram: 14 days
|
14 days
|
|
|
length of hospital stay
Tidsram: 14 days
|
14 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gary Frost, Imperial College London
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 13IC0065
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .