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Completed

NCT Number: 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).

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Key information

Conditions

Delirium Confusion Critical Illness Disease Attributes Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 5EF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Delirium prevalence

    Time frame: 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.

Secondary outcomes

  1. Proportion of patient-days with delirium

    Time frame: 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.

  2. Median delirium duration

    Time frame: 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.

  3. Median days to transition to delirium

    Time frame: 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.

  4. Patient age, by delirium status

    Time frame: 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.

  5. Patient gender, by delirium status

    Time frame: 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.

  6. Admission type, by delirium status

    Time frame: 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.

  7. Admission reason, by delirium status

    Time frame: 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.

  8. Organ support, by delirium status

    Time frame: 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.

  9. Mobilisation therapy, by delirium status

    Time frame: 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.

  10. Median ICU days, by delirium status

    Time frame: 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.

  11. Delirium screening compliance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Collaborators

  • Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN)

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2013
Registry last updated
Jul 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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