Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Study Overview
Brief Summary
The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •post anoxic coma
- •over 18 years old
- •agreement from families
- •alive 4 days after the beginning of coma
Exclusion Criteria
- •traumatic coma
- •non-traumatic but not anoxic coma
- •patients with severe comorbidity previous to coma
- •refusal of families to participate to the study
- •contraindication to a high-density electroencephalography exam
Arms & Interventions
electroencephalography recording
Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously
Intervention: high-density electroencephalography (Device)
electroencephalography recording
Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously
Intervention: Conventional electroencephalography (Device)
Outcomes
Primary Outcomes
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Time Frame: 4 days after the beginning of coma
mismatch negativity is an electrophysiological response recorded after the presentation of deviant auditory stimulations Recovery is assessed 1 month after the beginning of coma
Secondary Outcomes
- Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography(19 days after the beginning of coma)
- Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography(7 days after the beginning of coma)