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

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.

Study Overview

• Status: Unknown
• Conditions: Brain Death; Coma
• Intervention / Treatment: Procedure: Oxygen supply of high-low-high procedure; Procedure: Oxygen supply of low-high-low procedure

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.

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • NIRS assessment for brain death

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult individuals of any gender. Hired from Intensive Care Center of Sichuan Provincial People's Hospital，Shanghai Xinhua Hospital and Tianjin Huanhu Hospital

Description

Inclusion Criteria:

• Patients who have had brain death or serious brain trauma.
• Patients who have deep coma with autonomous respiration according to GCS coma Scale
• Healthy people who are interested in optical assessment of hemodynamic parameters

Exclusion Criteria:

• Patients who are in pregnancy or have plan to conception.
• Patients who have vertebra surgery or have plan of surgery.
• Patients who are inappropriate to join this trial judged by the radiologists or specialists.
• AIDS, Active Hepatitis, Tuberculosis, Syphilis
• Patients who regularly take anticoagulants, antiplatelet drugs

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brain death patients for HLH Oxygen; Brain-dead patients were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of high-low-high procedure. During the procedures, the Δ[Hb] and Δ[HbO2] time courses were collected by the NIRS instrument for hemodynamic parameter.	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.
Brain death patients for LHL Oxygen; Brain-dead patients were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of low-high-low procedure. During the procedures, the Δ[Hb] and Δ[HbO2] time courses were collected by the NIRS instrument for hemodynamic parameter.	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.
Deep coma patients for HLH Oxygen; Deep coma patients were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of high-low-high procedure. During the procedures, the Δ[Hb] and Δ[HbO2] time courses were collected by the NIRS instrument for hemodynamic parameter.	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.
Deep coma patients for LHL Oxygen; Deep coma patients were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of low-high-low procedure. During the procedures, the Δ[Hb] and Δ[HbO2] time courses were collected by the NIRS instrument for hemodynamic parameter.	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.
Healthy people for HLH Oxygen; Healthy people were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of high-low-high procedure. During the procedures, the Δ[Hb] and Δ[HbO2] time courses were collected by Optical monitor for hemodynamic parameter.	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.
Healthy people for LHL Oxygen; Healthy people were supplied with oxygen at varied FIO2 at medical premised range.The protocol is Oxygen supply of low-high-low procedure. During the procedures, the Δ[Hb] and Δ[HbO2] time courses were collected by Optical monitor for hemodynamic parameter.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Δ[HbO2]	The changes of oxyhemoglobin concentrations in prefrontal cortex.	1 day during the whole experiment
Δ[Hb]	The changes of deoxyhemoglobin concentrations in prefrontal cortex.	1 day during the whole experiment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate of patient recorded by bed-side physiological monitor.	1 day during the whole experiment
Blood pressure	Blood pressure of patient recorded by bed-side physiological monitor.	1 day during the whole experiment

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

General Publications

• Pan B, Huang C, Fang X, Huang X, Li T. Noninvasive and sensitive optical assessment of brain death. J Biophotonics. 2019 Mar;12(3):e201800240. doi: 10.1002/jbio.201800240. Epub 2018 Dec 13.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 10, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Near infrared spectroscopy; Brain death; Deep coma; Oxygen metabolism
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Death; Brain Death; Coma
• Other Study ID Numbers: NIRS for brain death and coma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No