NCT04623294

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

Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy With Protocol at Varied Fraction of Inspired O2

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

Brain death is an irreversible loss of all brain functions, while deep coma is a profound state of unconsciousness associated with depressed cerebral activity. Timely distinguishing the two states is crucial for saving patients. The noninvasive, sensitive, universally available, and timely ancillary method to assess brain death and deep coma has not been established. This study aims to explore a noninvasive and straightforward way in brain death and deep coma online assessment. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy instrument attached on the forehead of participators. A multiple-phase protocol at varied fraction of inspired O2(FIO2) were utilized during the assessment. Then the investigators compared the multiple physiological parameters changes among different groups at different FIO2.

Conditions

• Brain Death
• Coma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-10
• Primary completion: 2021-03-31
• Completion: 2022-12-31
• First posted: 2020-11-10
• Last updated: 2020-11-10

Locations

1 site across 1 country: China