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

Coma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04623294
• Other study ID #: NIRS for brain death and coma
• Status: Not yet recruiting
• Start date: November 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Coma
• Death

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	NIRS assessment for brain death	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?[HbO2]	The changes of oxyhemoglobin concentrations in prefrontal cortex.	1 day during the whole experiment
Primary	?[Hb]	The changes of deoxyhemoglobin concentrations in prefrontal cortex.	1 day during the whole experiment
Secondary	Heart rate	Heart rate of patient recorded by bed-side physiological monitor.	1 day during the whole experiment
Secondary	Blood pressure	Blood pressure of patient recorded by bed-side physiological monitor.	1 day during the whole experiment