- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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).
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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Cambridgeshire
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Cambridge, Cambridgeshire, Egyesült Királyság, CB23 5EF
- Papworth Hospital NHS Foundation Trust
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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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Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
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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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Delirium prevalence
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Proportion of patient-days with delirium
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Alain Vuylsteke, MD, Papworth Hospital NHS Foundation Trust
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- P01535
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