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Optical Assessment on Brain Death Via a Oxygen Supply Procedure

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ClinicalTrials.gov Identifier: NCT03864887
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ting Li, 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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Optical Assessment on Brain Death Via a Multiple-phase Protocol at Varied Fraction of Inspired O2
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. Δ[HbO2] [ Time Frame: 1 day during the whole experiment ]
    The changes of oxyhemoglobin concentrations in prefrontal cortex.

  2. Δ[Hb] [ Time Frame: 1 day during the whole experiment ]
    The changes of deoxyhemoglobin concentrations in prefrontal cortex.


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 1 day during the whole experiment ]
    Heart rate of patient recorded by bed-side physiological monitor.

  2. Blood pressure [ Time Frame: 1 day during the whole experiment ]
    Blood pressure of patient recorded by bed-side physiological monitor.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult individuals of any gender. Mostly hired in the City of Tianjin, P.R.China
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864887


Locations
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China, Tianjin
NIRS assessment for brain death Recruiting
Tianjin, Tianjin, China, 300000
Contact: Chenyang Gao, Doctor    +86 16622803399    505358234@qq.com   
Contact: , Doctor         
Sponsors and Collaborators
Chinese Academy of Medical Sciences

Additional Information:
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Responsible Party: Ting Li, Professer, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03864887     History of Changes
Other Study ID Numbers: Brain Death of AMS
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ting Li, Chinese Academy of Medical Sciences:
Brain death
Oxygen metabolism
Near infrared spectroscopy

Additional relevant MeSH terms:
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Death
Brain Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations