Optical Assessment on Brain Death Via a Oxygen Supply Procedure

Brain Death Clinical Trial

Official title:

Optical Assessment on Brain Death Via a Multiple-phase Protocol at Varied Fraction of Inspired O2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03864887
• Other study ID #: Brain Death of AMS
• Status: Recruiting
• Start date: February 11, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• 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 evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. 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, and the assessment is crucial for organ supply for transplantation. The noninvasive, sensitive, universally available and timely ancillary method to assess brain death has not been established. This study aims to evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment. The concentration changes ratios of oxyhemoglobin to deoxyhemoglobin (Δ[HbO2]/Δ[Hb]) in the cerebral cortex of brain-dead patients were significantly higher than those of healthy subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2019
• Est. primary completion date: August 1, 2019
• 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.

• 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
• 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).
• 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 probes of tow wavelengths were attached on the subjects' foreheat 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, 

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

External Links

•   A published SCI paper named "Noninvasive and sensitive optical assessment of brain death" written by the investigaters