- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01902277
ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region
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).
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Cambridgeshire
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Cambridge, Cambridgeshire, Vereinigtes Königreich, CB23 5EF
- Papworth Hospital NHS Foundation Trust
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK
Exclusion Criteria:
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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Adult critically ill patients
All adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Delirium prevalence
Zeitfenster: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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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.
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June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Proportion of patient-days with delirium
Zeitfenster: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Number of patient-days with at least one recorded delirium-positive result over total patient-days recorded.
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June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Median delirium duration
Zeitfenster: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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In delirium patients: median number of days recorded with delirium over study time frame.
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June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Median days to transition to delirium
Zeitfenster: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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In delirium patients admitted during study time frame: median number of days from ICU admission to first recorded delirium day.
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June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Patient age, by delirium status
Zeitfenster: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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In delirium patients versus patients with no recorded delirium-positive result over study time frame: median age.
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June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Patient gender, by delirium status
Zeitfenster: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of males over total patients in each group.
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June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Admission type, by delirium status
Zeitfenster: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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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.
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June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Admission reason, by delirium status
Zeitfenster: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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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.
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June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Organ support, by delirium status
Zeitfenster: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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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.
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June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Mobilisation therapy, by delirium status
Zeitfenster: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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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.
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June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Median ICU days, by delirium status
Zeitfenster: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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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.
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June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Delirium screening compliance
Zeitfenster: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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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.
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June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Alain Vuylsteke, MD, Papworth Hospital NHS Foundation Trust
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P01535
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Klinische Studien zur Delirium
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Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicRekrutierungDelirium im Alter | Delirium gemischten Ursprungs | Demenz überlagertes Delirium | Delirium Verwirrter ZustandNorwegen
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Universidad de SantanderUnbekanntDelirium gemischten Ursprungs | Hypoaktives Delirium | Hyperaktives DeliriumKolumbien
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Imperial College Healthcare NHS TrustRekrutierungHerzchirugie | Intensivstation Delirium | Postoperatives DeliriumVereinigtes Königreich
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Efficacy Care R&D LtdHadassah Medical OrganizationUnbekanntDelirium | Delirium, Ursache unbekannt | Delirium gemischten Ursprungs | Delirium Verwirrter Zustand | Medikamenteninduziertes DelirIsrael
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Azienda Ospedaliero-Universitaria di ParmaRekrutierungPostoperatives Delirium | Herzchirugie | Intensivstation DeliriumItalien
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University of Southern CaliforniaRekrutierungDelirium | Nebenwirkungen der Behandlung | Moral | Delirium im Alter | Psych | Delirium gemischten Ursprungs | Delirium Verwirrter Zustand | Delirium, Sepsis assoziiertVereinigte Staaten
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Indonesia UniversityNoch keine RekrutierungPostoperatives Delirium | Anästhesie | Postoperative Verwirrung | Neurologische Störung | Anästhesie Entstehung Delirium | Gas; Inhalation | Hypnotisch; Entzugszustand mit Delirium
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Bruyere Research InstituteThe Ottawa Hospital; Foothills Medical Centre; Bruyère Continuing CareRekrutierungDelirium gemischten Ursprungs | Hyperaktives DeliriumKanada
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Penn State UniversityBeth Israel Deaconess Medical Center; Mount Nittany Medical Center; Penn State...Noch keine RekrutierungDelirium | Delirium im Alter | Demenz überlagertes Delirium | Delirium mit Demenz