The Reliability Assessment of Emergency Paramedics' Fatigue Using Automated Pupillometry

Completed

• Conditions: Mental Fatigue; Emergency Paramedics' Fatigue

• Registration Number: NCT04954430
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-14
• Primary Completion: 2021-04-18
• Study Completion: 2021-04-18
• Status Verified: 2021-05
• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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)	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

Name	Time	Method
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.

Trial Locations

Locations (1)

Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China