NCT04551508

Brief Summary

Observational study comparing three different methods of delirium detection in critically ill patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,126

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

September 9, 2020

Last Update Submit

March 31, 2022

Conditions

DeliriumCritical Illness

Outcome Measures

Primary Outcomes (3)

  • Confusion Assessment Method of the Intensive Care Unit (CAM-ICU)

    Clinical test for detecting delirium bedside, can be used by non-psychiatrists. CAM-ICU can be either positive (indicating delirium) or negative.

    Day 1

  • Confusion assessment method of the intensive care unit 7 (CAM-ICU -7)

    Clinical test for detecting delirium bedside, can be used by non-psychiatrists. CAM-ICU-7 can yield a score of 0-7 points, higher values indicative of worse delirium.

    Day 1

  • intensive care delirium screening checklist (ICDSC)

    Clinical test for detecting delirium bedside, can be used by non-psychiatrists. ICDSC can yield a score of 0-8 points, higher values indicative of worse delirium.

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients admitted to critical care units may be included in this study.

You may qualify if:

  • All patients admitted to critical care units.

You may not qualify if:

  • Patients with RASS score of -3, -4, -5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Regionshospitalet Herning

Herning, Central Jutland, 7400, Denmark

Location

Regionshospitalet Holstebro

Holstebro, Central Jutland, 7500, Denmark

Location

Odense Universitetshospital

Odense, C, 5000, Denmark

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Aarhus Universitetshospital

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

Sydvestjysk sygehus

Esbjerg, 6700, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Regionshospitalet Horsens

Horsens, 8700, Denmark

Location

Sjællands Universitetshospital

Køge, 4600, Denmark

Location

Regionshospitalet Randers

Randers, 8930, Denmark

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

Regionshospitalet Viborg

Viborg, 8800, Denmark

Location

Related Publications (5)

  • Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, Chlan LL, Boustani MA. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017 May;45(5):851-857. doi: 10.1097/CCM.0000000000002368.

    PMID: 28263192BACKGROUND

  • Bergeron N, Dubois MJ, Dumont M, Dial S, Skrobik Y. Intensive Care Delirium Screening Checklist: evaluation of a new screening tool. Intensive Care Med. 2001 May;27(5):859-64. doi: 10.1007/s001340100909.

    PMID: 11430542BACKGROUND

  • Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.

    PMID: 11445689BACKGROUND

  • Almgren M, Lundmark M, Samuelson K. The Richmond Agitation-Sedation Scale: translation and reliability testing in a Swedish intensive care unit. Acta Anaesthesiol Scand. 2010 Jul;54(6):729-35. doi: 10.1111/j.1399-6576.2009.02173.x. Epub 2009 Dec 5.

    PMID: 20002362BACKGROUND

  • Granholm A, Perner A, Krag M, Marker S, Hjortrup PB, Haase N, Holst LB, Collet MO, Jensen AKG, Moller MH. External validation of the Simplified Mortality Score for the Intensive Care Unit (SMS-ICU). Acta Anaesthesiol Scand. 2019 Oct;63(9):1216-1224. doi: 10.1111/aas.13422. Epub 2019 Jul 4.

    PMID: 31273763BACKGROUND

MeSH Terms

Conditions

DeliriumCritical Illness

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersDisease AttributesPathologic Processes

Study Officials

  • Helle Svenningsen, ph.d.

    VIA University College, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MCN, PH.D.

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

September 9, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations

DK(14)