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

17 juillet 2013 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

225

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Cambridgeshire
      • Cambridge, Cambridgeshire, Royaume-Uni, CB23 5EF
        • Papworth Hospital NHS Foundation Trust

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Adult critically ill patients across eastern UK region

La description

Inclusion Criteria:

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

Exclusion Criteria:

-

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Delirium prevalence
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of patient-days with delirium
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2012

Achèvement primaire (Réel)

1 juillet 2012

Achèvement de l'étude (Réel)

1 juillet 2012

Dates d'inscription aux études

Première soumission

15 juillet 2013

Première soumission répondant aux critères de contrôle qualité

17 juillet 2013

Première publication (Estimation)

18 juillet 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

18 juillet 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juillet 2013

Dernière vérification

1 juillet 2013

Plus d'information

Termes liés à cette étude

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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