Brain DeathNCT03864887
Optical Assessment on Brain Death Via a Oxygen Supply Procedure
An observational study of Brain Death, run by Chinese Academy of Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Death
- What is being tested?
- Oxygen supply of high-low-high procedure, Oxygen supply of low-high-low procedure and Optical monitor for hemodynamic parameter.
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2019to 31 Dec 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult individuals of any gender. Mostly hired in the City of Tianjin, P.R.China
Who may be able to join
- Patients who have had brain death or serious brain trauma.
- Healthy people who are interested in optical assessment of hemodynamic parameters
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NIRS assessment for brain death
Tianjin, Tianjin Municipality, 300000
Chenyang Gao, Doctor, +86 16622803399, 505358234@qq.com
Doctor
About this study
Official title: Optical Assessment on Brain Death Via a Multiple-phase Protocol at Varied Fraction of Inspired O2
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.
Read the 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.
- Conditions
- Brain Death
- Being tested
- Oxygen supply of high-low-high procedure, Oxygen supply of low-high-low procedure, Optical monitor for hemodynamic parameter.
- Keywords
- Brain death, Oxygen metabolism, Near infrared spectroscopy
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen supply of high-low-high procedureProcedure or surgery
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 procedureProcedure or surgery
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Oxygen supply of low-high-low procedure; Device: Optical monitor for hemodynamic parameter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Δ[HbO2]
The changes of oxyhemoglobin concentrations in prefrontal cortex.
Measured: 1 day during the whole experiment
Δ[Hb]
The changes of deoxyhemoglobin concentrations in prefrontal cortex.
Measured: 1 day during the whole experiment
Secondary outcomes (2)
Heart rate
Heart rate of patient recorded by bed-side physiological monitor.
Measured: 1 day during the whole experiment
Blood pressure
Blood pressure of patient recorded by bed-side physiological monitor.
Measured: 1 day during the whole experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start11 Feb 2019
- Primary completion1 Aug 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Li, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864887
- Sponsor's protocol ID
- Brain Death of AMS
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Assessment on Brain Death Via a Multiple-phase Protocol at Varied Fraction of Inspired O2
- ClinicalTrials.gov ID
- NCT03864887
- Acronym / sponsor ID
- Brain Death of AMS
- Conditions
- Brain Death
- Keywords
- Brain death, Oxygen metabolism, Near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brain death patients for HLH Oxygen | – | Procedure: Oxygen supply of high-low-high procedure, Device: 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. |
| Brain death patients for LHL Oxygen | – | Procedure: Oxygen supply of low-high-low procedure, Device: 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 HLH Oxygen | – | Procedure: Oxygen supply of high-low-high procedure, Device: 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. |
| Healthy people for LHL Oxygen | – | Procedure: Oxygen supply of low-high-low procedure, Device: 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult individuals of any gender. Mostly hired in the City of Tianjin, P.R.China
Key inclusion criteria (2 listed)
- Patients who have had brain death or serious brain trauma.
- Healthy people who are interested in optical assessment of hemodynamic parameters
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen supply of high-low-high procedureThe 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). | Procedure or surgery | Brain death patients for HLH Oxygen, Healthy people for HLH Oxygen |
| Oxygen supply of low-high-low procedureThe 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). | Procedure or surgery | Brain death patients for LHL Oxygen, Healthy people for LHL Oxygen |
| 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. | Device | Brain death patients for HLH Oxygen, Brain death patients for LHL Oxygen, Healthy people for HLH Oxygen, Healthy people for LHL Oxygen |
Primary outcome
Δ[HbO2]
Time frame: 1 day during the whole experiment
The changes of oxyhemoglobin concentrations in prefrontal cortex.
Δ[Hb]
Time frame: 1 day during the whole experiment
The changes of deoxyhemoglobin concentrations in prefrontal cortex.
2 secondary outcomes
Heart rate
Time frame: 1 day during the whole experiment
Blood pressure
Time frame: 1 day during the whole experiment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Death, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Δ[HbO2] (time frame: 1 day during the whole experiment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.