Automated Screening for Clinically Ascertained Loss of Cerebral Functions

NCT ID: NCT06293170

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-11-01

Brief Summary

Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF.

Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support.

Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trial

Study population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge.

Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination.

Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization.

Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT.

Conditions

Irreversible Loss of Brain Function (ILBF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Control

Conventional care alone

Group Type: OTHER

Conventional care

Intervention Type: OTHER

Conventional care

DETECT

DETECT in addition to conventional care will be initiated according to randomization plan

Group Type: EXPERIMENTAL

DETECT

Intervention Type: OTHER

DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination.

Conventional care

Intervention Type: OTHER

Conventional care

Interventions

DETECT

DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination.

Intervention Type: OTHER

Conventional care

Conventional care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Primary and/or secondary acute brain damage
• At least 18 years or older
• Necessity of mechanical ventilation
• Deceased upon hospital discharge

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Kristian Barlinn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristian Barlinn, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany

Locations

Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden

Dresden, , Germany

Countries

Germany

Central Contacts

Kristian Barlinn, MD

Role: CONTACT

kristian.barlinn@ukdd.de

+49 (0) 351 - 458-3565

Facility Contacts

Kristian Barlinn, MD

Role: primary

kristian.barlinn@ukdd.de

+49 (0)351 458 3565

References

Trabitzsch A, Pleul K, Barlinn K, Franz V, Dengl M, Gotze M, Guldner A, Eberlein-Gonska M, Albrecht DM, Hugo C. An Automated Electronic Screening Tool (DETECT) for the Detection of Potentially Irreversible Loss of Brain Function. Dtsch Arztebl Int. 2021 Oct 15;118(41):683-690. doi: 10.3238/arztebl.m2021.0307.

Reference Type: BACKGROUND

PMID: 34551858 (View on PubMed)

Schoene D, Freigang N, Trabitzsch A, Pleul K, Kaiser DPO, Roessler M, Winzer S, Hugo C, Gunther A, Puetz V, Barlinn K. Identification of patients at high risk for brain death using an automated digital screening tool: a prospective diagnostic accuracy study. J Neurol. 2023 Dec;270(12):5935-5944. doi: 10.1007/s00415-023-11938-1. Epub 2023 Aug 25.

Reference Type: BACKGROUND

PMID: 37626244 (View on PubMed)

Related Links

https://www.detect-iha.de/

Related Info

Other Identifiers

2024-DETECTIVENEUROLOGYUKD0001

Identifier Type: -

Identifier Source: org_study_id