Automated Screening for Clinically Ascertained Loss of Cerebral Functions
- Conditions
- Irreversible Loss of Brain Function (ILBF)
- Interventions
- Other: DETECTOther: Conventional care
- Registration Number
- NCT06293170
- Lead Sponsor
- Technische Universität Dresden
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 4800
- Primary and/or secondary acute brain damage
- At least 18 years or older
- Necessity of mechanical ventilation
- Deceased upon hospital discharge
• none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description DETECT Conventional care DETECT in addition to conventional care will be initiated according to randomization plan Control Conventional care Conventional care alone DETECT DETECT DETECT in addition to conventional care will be initiated according to randomization plan
- Primary Outcome Measures
Name Time Method Number of patients with diagnosis of ILBF 30 months The primary outcome is defined as proportion of patients with an eventual diagnosis of ILBF in accordance with the guidelines of the German Medical Association during hospitalization.
- Secondary Outcome Measures
Name Time Method Number of patients who undergo deceased organ donation 30 months The secondary outcome is defined as proportion of patients who undergo deceased organ donation.
Number of patients in whom diagnosis of ILBF was missed 30 months The secondary outcome is defined as the failure to identify potential cases of ILBF. This outcome measure will be determined through retrospective evaluation of all deceased cases who were not diagnosed with ILBF during hospitalization. For this purpose, independent neurointensivists will review computed tomography and/or magnetic resonance imaging scans for findings indicative of critical intracranial pressure such as severe hypoxic cerebral edema, intracerebral hemorrhage with intraventricular extension or space-occupying hemispheric infarction, in addition to clinical information. The final decision regarding the potential development of ILBF will be based on consensus between two neurointensivists.
Trial Locations
- Locations (1)
Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden
🇩🇪Dresden, Germany