Optical Assessment on Brain Death Via a Oxygen Supply Procedure

NCT03864887 | Unknown

• 1 other identifier: Brain Death of AMS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Death

Keywords

Brain death; Oxygen metabolism; Near infrared spectroscopy

Outcome Measures

Primary Outcomes (2)

• Δ[HbO2]

  The changes of oxyhemoglobin concentrations in prefrontal cortex.

  1 day during the whole experiment

• Δ[Hb]

  The changes of deoxyhemoglobin concentrations in prefrontal cortex.

  1 day during the whole experiment

Secondary Outcomes (2)

• Heart rate

  1 day during the whole experiment

• Blood pressure

  1 day during the whole experiment

Study Arms (4)

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; Device: Optical monitor for hemodynamic parameter.

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; Device: Optical monitor for hemodynamic parameter.

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; Device: Optical monitor for hemodynamic parameter.

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; Device: Optical monitor for hemodynamic parameter.

Interventions

Oxygen supply of high-low-high procedure 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).

Brain death patients for HLH Oxygen; Healthy people for HLH Oxygen

Oxygen supply of low-high-low procedure 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).

Brain death patients for LHL Oxygen; Healthy people for LHL Oxygen

Optical monitor for hemodynamic parameter. DEVICE

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

Brain death patients for HLH Oxygen; Brain death patients for LHL Oxygen; Healthy people for HLH Oxygen; Healthy people for LHL Oxygen

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult individuals of any gender. Mostly hired in the City of Tianjin, P.R.China

You may qualify if:

• Patients who have had brain death or serious brain trauma.
• Healthy people who are interested in optical assessment of hemodynamic parameters

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

NIRS assessment for brain death

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professer

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 6, 2019
• Study Start: February 11, 2019
• Primary Completion: August 1, 2019
• Study Completion: December 31, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

CN (1)