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ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region

17 de julho de 2013 atualizado por: Papworth Hospital NHS Foundation Trust

ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical workflow of the ICU. Effective healthcare resource planning requires reliable (i.e., multicentre) data that can inform on both of these.

The purpose of this study was to determine the impact of ICU delirium in terms of both patients and beds. The study was carried out prospectively, over a one-week period, at adult ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

Previous delirium prevalence research has been carried out at single sites and yielded highly variable results (between 3-87%). Reliable multisite data can be obtained cost-effectively using a point-prevalence ("snapshot") approach.

Purpose: to obtain reliable data informing on prevalence of ICU delirium, in terms of both patients and beds, across the eastern UK region.

Design and Setting: this one-week observational prospective cohort study was carried out between June 25, 2012 (start of ICU day shift) to July 01, 2012 (end of night shift). Nine ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN) took part. Cambridgeshire 2 Research Ethics Committee approved the study (REC reference: 10/H0308/116) and waived the need for informed consent.

Patients and procedure: All adults treated over the study week at participating ICUs were considered eligible for inclusion. Delirium screening was carried out by patients' direct care clinicians using the Confusion Assessment Method for the ICU (CAM-ICU). All sites used this tool as part of their routine clinical practice and had delirium management guidelines in place at the time of the study. Patients who screened positive for delirium were treated according to local hospital practice.

Tipo de estudo

Observacional

Inscrição (Real)

225

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Cambridgeshire
      • Cambridge, Cambridgeshire, Reino Unido, CB23 5EF
        • Papworth Hospital NHS Foundation Trust

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Adult critically ill patients across eastern UK region

Descrição

Inclusion Criteria:

  • Adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK

Exclusion Criteria:

-

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Adult critically ill patients
All adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Delirium prevalence
Prazo: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Number of patients with at least one recorded delirium-positive result, over total number of patients recorded over study time frame. Delirium screening will be carried out using the CAM-ICU by local direct care clinicians in accordance with region-wide clinical delirium-screening guidelines.
June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of patient-days with delirium
Prazo: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Number of patient-days with at least one recorded delirium-positive result over total patient-days recorded.
June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Median delirium duration
Prazo: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
In delirium patients: median number of days recorded with delirium over study time frame.
June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Median days to transition to delirium
Prazo: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
In delirium patients admitted during study time frame: median number of days from ICU admission to first recorded delirium day.
June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Patient age, by delirium status
Prazo: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
In delirium patients versus patients with no recorded delirium-positive result over study time frame: median age.
June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Patient gender, by delirium status
Prazo: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of males over total patients in each group.
June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Admission type, by delirium status
Prazo: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of (1) urgent/emergency and (2) elective admissions, over total patients in each group.
June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Admission reason, by delirium status
Prazo: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of (1) medical and (2) surgical admissions, over total patients in each group.
June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Organ support, by delirium status
Prazo: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number receiving advanced and basic respiratory, advanced and basic cardiovascular, and renal support since ICU admission to end of study time frame, over total patients in each group.
June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Mobilisation therapy, by delirium status
Prazo: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
In delirium patients versus patients with no recorded delirium-positive result over study time frame: number receiving mobilisation therapy over study time frame, over total patients in each group.
June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Median ICU days, by delirium status
Prazo: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
In delirium patients versus patients with no recorded delirium-positive result over study time frame: median number of patient-days in ICU per patient, since admission to end of study time frame.
June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Delirium screening compliance
Prazo: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Number of patient-days CAM-ICU administered (1) once or more and (2) twice or more, over total number of patient-days recorded over study time frame.
June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Alain Vuylsteke, MD, Papworth Hospital NHS Foundation Trust

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de junho de 2012

Conclusão Primária (Real)

1 de julho de 2012

Conclusão do estudo (Real)

1 de julho de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

15 de julho de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de julho de 2013

Primeira postagem (Estimativa)

18 de julho de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

18 de julho de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2013

Última verificação

1 de julho de 2013

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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