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Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy

NCT04623294 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2020-11-10

No results posted yet for this study

Summary

This study aims to assess brain death and deep coma with the self-made near infrared spectroscopy (NIRS) instrument. The investigators used the noninvasive method to monitor the Δ\[HbO2\] (the concentration changes in oxy-hemoglobin) and Δ\[Hb\] (the concentration changes in deoxy-hemoglobin) in the region around the forehead of medically evaluated participating patients and healthy subjects. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment.

Conditions

  • Brain Death
  • Coma

Interventions

PROCEDURE

Oxygen supply of high-low-high procedure

The protocol consisted of 1-hour resting, 3-minute baseline measurement, half-hour measurement at 60% FIO2(phase I, high oxygen), half-hour measurement at 40% FIO2 (phase II, low oxygen) and half-hour measurement at 60% FIO2 (phase III, high oxygen). Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead to detect the changes of hemodynamic parameters.

PROCEDURE

Oxygen supply of low-high-low procedure

The protocol consisted of 1- hour resting, 3-minute baseline measurement, half-hour measurement at 40% FIO2 (phase I, low oxygen), half-hour measurement at 60% FIO2 (phase II, high oxygen) and half-hour measurement at 40% FIO2 (phase III, low oxygen). Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead to detect the changes of hemodynamic parameters.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2021-03-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04623294 on ClinicalTrials.gov