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

NCT04623294 | Unknown

• 1 other identifier: NIRS for brain death and coma
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Brain death; Deep coma; Oxygen metabolism; Near infrared spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Heart rate

  1 day during the whole experiment

• Blood pressure

  1 day during the whole experiment

Study Arms (6)

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

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

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

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

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

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

Interventions

Oxygen supply of high-low-high procedure 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 HLH Oxygen; Deep coma patients for HLH Oxygen; Healthy people for HLH Oxygen

Oxygen supply of low-high-low procedure 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.

Brain death patients for LHL Oxygen; Deep coma patients for LHL Oxygen; Healthy people for LHL Oxygen

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

NIRS assessment for brain death

Tianjin, Tianjin Municipality, 300000, China

Location

Related Publications (1)

• 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.

  PMID: 30379409 BACKGROUND

MeSH Terms

Conditions

Brain Death; Coma

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 10, 2020
• Study Start: November 10, 2020
• Primary Completion: March 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

CN (1)