- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Contactos e Locais
Locais de estudo
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London, Reino Unido
- Imperial College Healthcare NHS Trust
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London, Reino Unido, W2 1NY
- St Marys Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Mid Arm Circumference Change
Prazo: Day 1, 3, 7, 14
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Day 1, 3, 7, 14
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fluid Intake Change
Prazo: 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
Prazo: 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
Prazo: daily for 14 days
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daily for 14 days
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new diagnosis of aspiration pneumonia
Prazo: daily for 14 days
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daily for 14 days
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number of days requiring non-invasive ventilation
Prazo: 14 days
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14 days
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number of days requiring level 2 care
Prazo: 14 days
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14 days
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length of hospital stay
Prazo: 14 days
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14 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gary Frost, Imperial College London
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 13IC0065
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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