Optical Assessment on Brain Death Via a Oxygen Supply Procedure

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT03864887

Collaborator

(none)

Enrollment

Location

10.6

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain Death	Procedure: Oxygen supply of high-low-high procedure Procedure: Oxygen supply of low-high-low procedure Device: Optical monitor for hemodynamic parameter.

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 11, 2019

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	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 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 probes of tow wavelengths were attached on the subjects' foreheat 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 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 probes of tow wavelengths were attached on the subjects' foreheat 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 probes of tow wavelengths were attached on the subjects' foreheat 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 probes of tow wavelengths were attached on the subjects' foreheat to detect the changes of hemodynamic parameters.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate [1 day during the whole experiment]
Heart rate of patient recorded by bed-side physiological monitor.
Blood pressure [1 day during the whole experiment]
Blood pressure of patient recorded by bed-side physiological monitor.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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