Trial Outcomes & Findings for Continuous Quantified EEG in NeuroIntensive Care (NCT NCT02901262)

Results Overview

Percentage of correct evaluation of qEEG tracings by intensivists vs. neurophysiologist. The result will be expressed as percentage of correct evaluations for each domain.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

2 months

Results posted on

2024-03-22

Participant Flow

After the evaluation of qEEG (quantitative electroencephalography) from 30 patients, other intensivists and neurophysiologists were engaged to use the customized web-based online application that was downloaded on computers and cell phones to evaluate qEEG.

Unit of analysis: qEEG evaluations

Participant milestones

Participant milestones
Measure	Study Cohort From February to August 2016 periods of \>12 h of cEEG (continuous electroencephalography) were independently evaluated by intensivists and by neurophysiologists using a customized web-based online application that was downloaded on computers and cell phones. A total of 86 paired evaluations were performed in 30 patients, and 1740 h of qEEG (quantitative electroencephalography) was subsequently evaluated.
Overall Study STARTED	30 86
Overall Study COMPLETED	30 86
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	qEEG Patients n=30 Participants All the patients with continuous EEG (\>24 hours) in the two study units
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants
Sex: Female, Male Female	18 Participants n=30 Participants
Sex: Female, Male Male	12 Participants n=30 Participants
Region of Enrollment Italy	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Neuro-intensivists, after the in-house training

Percentage of correct evaluation of qEEG tracings by intensivists vs. neurophysiologist. The result will be expressed as percentage of correct evaluations for each domain.

Outcome measures

Outcome measures
Measure	Study Cohort n=86 qEEG evaluations From February to August 2016 periods of \>12 h of cEEG were independently evaluated by intensivists and by neurophysiologists using a customized web-based online application that was downloaded on computers and cell phones. A total of 86 paired evaluations were performed in 30 patients, and 1740 h of qEEG was subsequently evaluated.
Number of Correct qEEG Evaluations Simmetry	70 percentage of correct evaluation
Number of Correct qEEG Evaluations Sedation level	78 percentage of correct evaluation
Number of Correct qEEG Evaluations Seizures activities	69 percentage of correct evaluation
Number of Correct qEEG Evaluations artefact on continuous cEEG/qEEG tracings	82 percentage of correct evaluation

SECONDARY outcome

Timeframe: 12 months

Population: Agreement between neurophysiologists and intensivists in interpretation of the tracings after training

Comparison of the correct answers of the intensivist before and after a period of training. Results will be expressed as coefficient of agreement between neurophysiologists and intensivists in interpretation of the tracings of continuous electroencephalography using Cohen's kappa coefficient, after training

Outcome measures

Outcome measures
Measure	Study Cohort n=86 qEEG evaluations From February to August 2016 periods of \>12 h of cEEG were independently evaluated by intensivists and by neurophysiologists using a customized web-based online application that was downloaded on computers and cell phones. A total of 86 paired evaluations were performed in 30 patients, and 1740 h of qEEG was subsequently evaluated.
Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training Seizures	0.5 Kappa Coefficient Interval 0.3 to 0.7
Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training Simmetry	0.65 Kappa Coefficient Interval 0.5 to 0.8
Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training Artefacts	0.6 Kappa Coefficient Interval 0.4 to 0.8
Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training Sedation	0.75 Kappa Coefficient Interval 0.55 to 0.9

Adverse Events

qEEG Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Giuseppe Citerio

UNIMIB, ASST-MONZA San Gerardo Hospital

Phone: 0039 039 233 4316

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place