Clinical trial NCT04623294: Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy
Official title: Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy With Protocol at Varied Fraction of Inspired O2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Death
Coma
Keywords: Brain death
Deep coma
Oxygen metabolism
Near infrared spectroscopy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-11-10
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Δ[HbO2]
timeFrame: 1 day during the whole experiment
measure: Δ[Hb]
timeFrame: 1 day during the whole experiment
Secondary outcomes:
measure: Heart rate
timeFrame: 1 day during the whole experiment
measure: Blood pressure
timeFrame: 1 day during the whole experiment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: NIRS assessment for brain death
state: Tianjin
Study officials:
References:
citation: 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.