The Reliability Assessment of Emergency Paramedics' Fatigue Using Automated Pupillometry

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT04954430

Collaborator

(none)

Enrollment

Location

5.1

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Due to the limitations of current approaches to assess emergency paramedics' fatigue, a portable, quick, easy, and objective technique is required to be developed. The aim of the study was to investigate the reliability of automated pupillometry to assess mental fatigue based on a driver simulator.

Condition or Disease	Intervention/Treatment	Phase
Mental Fatigue Emergency Paramedics' Fatigue	Diagnostic Test: pupillometer

Study Design

Study Type:

Observational

Actual Enrollment :

32 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

The Reliability Assessment of Emergency Paramedics' Fatigue Using Automated Pupillometry

Actual Study Start Date :

Nov 14, 2020

Actual Primary Completion Date :

Apr 18, 2021

Actual Study Completion Date :

Apr 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
fatigue After enrollments, subjects were assigned to perform mental fatigue-inducing experiment-a 90 min of monotonous simulated driving task. They underwent repeated measurements of quantitative pupillary light reflex (PLR) using an automated quantitative pupillometer at baseline and at an interval of 30 min during the task. Subjective ratings, heart rate variability (HRV), and electroencephalography (EEG) were performed simultaneously.	Diagnostic Test: pupillometer The dynamic changes of PLR were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of PLR with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec. The device provided the examiner with maximum and minimum pupil size (Init and End), constriction percentage (%PLR), latency (LAT), constriction and dilation velocity (CV and DV), and T75.

Arm

Intervention/Treatment

fatigue

After enrollments, subjects were assigned to perform mental fatigue-inducing experiment-a 90 min of monotonous simulated driving task. They underwent repeated measurements of quantitative pupillary light reflex (PLR) using an automated quantitative pupillometer at baseline and at an interval of 30 min during the task. Subjective ratings, heart rate variability (HRV), and electroencephalography (EEG) were performed simultaneously.

Diagnostic Test: pupillometer

The dynamic changes of PLR were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of PLR with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec. The device provided the examiner with maximum and minimum pupil size (Init and End), constriction percentage (%PLR), latency (LAT), constriction and dilation velocity (CV and DV), and T75.

Outcome Measures

Primary Outcome Measures

subjective assessments [Baseline]
Karolinska Sleepiness Scale (KSS), a 9-point scale for assessing sleepiness with responses ranging from extremely alert (1) to very sleepy (9) .
subjective assessments [30 minutes]
Karolinska Sleepiness Scale (KSS), a 9-point scale for assessing sleepiness with responses ranging from extremely alert (1) to very sleepy (9) .
subjective assessments [60 minutes]
Karolinska Sleepiness Scale (KSS), a 9-point scale for assessing sleepiness with responses ranging from extremely alert (1) to very sleepy (9) .
subjective assessments [90 minutes]
Karolinska Sleepiness Scale (KSS), a 9-point scale for assessing sleepiness with responses ranging from extremely alert (1) to very sleepy (9) .
Standard deviation of the NN intervals of heart rate variability [Baseline]
Using the SA-3000P (Medicore, Korea) , subjects were instructed to stay with eyes open, be silent, and breath normally during measurement.
Standard deviation of the NN intervals of heart rate variability [30 minutes]
Using the SA-3000P (Medicore, Korea) , subjects were instructed to stay with eyes open, be silent, and breath normally during measurement.
Standard deviation of the NN intervals of heart rate variability [60 minutes]
Using the SA-3000P (Medicore, Korea) , subjects were instructed to stay with eyes open, be silent, and breath normally during measurement.
Standard deviation of the NN intervals of heart rate variability [90 minutes]
Using the SA-3000P (Medicore, Korea) , subjects were instructed to stay with eyes open, be silent, and breath normally during measurement.
%PLR (percentage of change) [Baseline]
The dynamic changes of pupillary light reflex were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of pupillary light reflex with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec.
%PLR (percentage of change) [30 minutes]
The dynamic changes of pupillary light reflex were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of pupillary light reflex with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec.
%PLR (percentage of change) [60 minutes]
The dynamic changes of pupillary light reflex were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of pupillary light reflex with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec.
%PLR (percentage of change) [90 minutes]
The dynamic changes of pupillary light reflex were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of pupillary light reflex with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec.

Secondary Outcome Measures

Electroencephalography power in theta band [Baseline]
The eego™ mylab system (ANT Neuro, Germany) was applied to record the raw electroencephalography signal, using a 64-channel waveguard™ original electrode cap with electrodes in accordance with the international 10 ~ 20 Montage system. electroencephalography was sampled with a frequency of 1kHz using an eego™ amplifier. Electrode impedences of the selected channels were kept below 5 kΩ before recording.
Electroencephalography power in theta band [30 minutes]
The eego™ mylab system (ANT Neuro, Germany) was applied to record the raw electroencephalography signal, using a 64-channel waveguard™ original electrode cap with electrodes in accordance with the international 10 ~ 20 Montage system. electroencephalography was sampled with a frequency of 1kHz using an eego™ amplifier. Electrode impedences of the selected channels were kept below 5 kΩ before recording.
Electroencephalography power in theta band [60 minutes]
The eego™ mylab system (ANT Neuro, Germany) was applied to record the raw electroencephalography signal, using a 64-channel waveguard™ original electrode cap with electrodes in accordance with the international 10 ~ 20 Montage system. electroencephalography was sampled with a frequency of 1kHz using an eego™ amplifier. Electrode impedences of the selected channels were kept below 5 kΩ before recording.
Electroencephalography power in theta band [90 minutes]
The eego™ mylab system (ANT Neuro, Germany) was applied to record the raw electroencephalography signal, using a 64-channel waveguard™ original electrode cap with electrodes in accordance with the international 10 ~ 20 Montage system. electroencephalography was sampled with a frequency of 1kHz using an eego™ amplifier. Electrode impedences of the selected channels were kept below 5 kΩ before recording.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All participants held valid driving license of more than 2 years, with at least half of a year driving experience, had regular sleep pattern, normal or corrected to normal vision and no history of any psychiatric disorder.