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

17 juli 2013 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

225

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Cambridgeshire
      • Cambridge, Cambridgeshire, Verenigd Koninkrijk, CB23 5EF
        • Papworth Hospital NHS Foundation Trust

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Adult critically ill patients across eastern UK region

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Delirium prevalence
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of patient-days with delirium
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Alain Vuylsteke, MD, Papworth Hospital NHS Foundation Trust

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2012

Primaire voltooiing (Werkelijk)

1 juli 2012

Studie voltooiing (Werkelijk)

1 juli 2012

Studieregistratiedata

Eerst ingediend

15 juli 2013

Eerst ingediend dat voldeed aan de QC-criteria

17 juli 2013

Eerst geplaatst (Schatting)

18 juli 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

18 juli 2013

Laatste update ingediend die voldeed aan QC-criteria

17 juli 2013

Laatst geverifieerd

1 juli 2013

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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