Automated Screening for Clinically Ascertained Loss of Cerebral Functions (DETECT-IVE)

Technische Universität Dresden

Status: Not yet enrolling

Conditions: Irreversible Loss of Brain Function (ILBF)

Treatments: Other: DETECT; Other: Conventional care

Study type: Interventional

Funder types: Other

Identifiers

NCT06293170

2024-DETECTIVENEUROLOGYUKD0001

Details and patient eligibility

About

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.

Enrollment: 4,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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4,800 participants in 2 patient groups

Control

Other group

Description:

Conventional care alone

Treatment:

Other: Conventional care

DETECT

Experimental group

Description:

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

Treatment:

Other: DETECT

Other: Conventional care