Optical Assessment on Brain Death Via a Oxygen Supply Procedure

• Conditions: Brain Death
• Interventions: Procedure: Oxygen supply of high-low-high procedure; Procedure: Oxygen supply of low-high-low procedure; Device: Optical monitor for hemodynamic parameter.

• Registration Number: NCT03864887
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

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 Timeline

• Study Start: 2019-02-11
• Status Verified: 2019-03
• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-06
• Primary Completion: 2019-08-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy people for HLH Oxygen	Oxygen supply of high-low-high procedure	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.
Brain death patients for HLH Oxygen	Oxygen supply of high-low-high procedure	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.
Healthy people for LHL Oxygen	Optical monitor for hemodynamic parameter.	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.
Brain death patients for LHL Oxygen	Oxygen supply of low-high-low procedure	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.
Brain death patients for LHL Oxygen	Optical monitor for hemodynamic parameter.	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.
Healthy people for LHL Oxygen	Oxygen supply of low-high-low procedure	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.
Brain death patients for HLH Oxygen	Optical monitor for hemodynamic parameter.	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.
Healthy people for HLH Oxygen	Optical monitor for hemodynamic parameter.	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

NIRS assessment for brain death; 🇨🇳 Tianjin, Tianjin, China