Brain DeathNCT04623294
Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy
An observational study of Brain Death and Coma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study aims to assess brain death and deep coma with the self-made near infrared spectroscopy (NIRS) instrument. The investigators used the noninvasive method to monitor the Δ[HbO2] (the concentration changes in oxy-hemoglobin) and Δ[Hb] (the concentration changes in deoxy-hemoglobin) in the region around the… 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, Coma
- What is being tested?
- Oxygen supply of high-low-high procedure and Oxygen supply of low-high-low procedure
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2020to 31 Dec 2022
- 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. Hired from Intensive Care Center of Sichuan Provincial People's Hospital，Shanghai Xinhua Hospital and Tianjin Huanhu Hospital
Who may be able to join
- Patients who have had brain death or serious brain trauma.
- Patients who have deep coma with autonomous respiration according to GCS coma Scale
- 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
NIRS assessment for brain death
Tianjin, Tianjin Municipality, 300000
About this study
Official title: Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy With Protocol at Varied Fraction of Inspired O2
This study aims to assess brain death and deep coma with the self-made near infrared spectroscopy (NIRS) instrument. The investigators used the noninvasive method to monitor the Δ[HbO2] (the concentration changes in oxy-hemoglobin) and Δ[Hb] (the concentration changes in deoxy-hemoglobin) in the region around the forehead of medically evaluated participating patients and healthy subjects. 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, while deep coma is a profound state of unconsciousness associated with depressed cerebral activity. Timely distinguishing the two states is crucial for saving patients. The noninvasive, sensitive, universally available, and timely ancillary method to assess brain death and deep coma has not been established. This study aims to explore a noninvasive and straightforward way in brain death and deep coma online assessment. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy instrument attached on the forehead of participators. A multiple-phase protocol at varied fraction of inspired O2(FIO2) were utilized during the assessment. Then the investigators compared the multiple physiological parameters changes among different groups at different FIO2.
- Conditions
- Brain Death, Coma
- Being tested
- Oxygen supply of high-low-high procedure, Oxygen supply of low-high-low procedure
- Keywords
- Brain death, Deep coma, Oxygen metabolism, Near infrared spectroscopy
- Medical subject headings
- Brain Death, Coma
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).
Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead to detect the changes of hemodynamic parameters.
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).
Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead 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 the NIRS instrument for hemodynamic parameter. Receives: Procedure: Oxygen supply of high-low-high procedure | |
| 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 the NIRS instrument for hemodynamic parameter. Receives: Procedure: Oxygen supply of low-high-low procedure | |
| Deep coma patients for HLH Oxygen | Deep coma 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 the NIRS instrument for hemodynamic parameter. Receives: Procedure: Oxygen supply of high-low-high procedure | |
| Deep coma patients for LHL Oxygen | Deep coma 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 the NIRS instrument for hemodynamic parameter. Receives: Procedure: Oxygen supply of low-high-low procedure | |
| 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 | |
| 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 |
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 posted10 Nov 2020
- Study start10 Nov 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 75 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
- NCT04623294
- Sponsor's protocol ID
- NIRS for brain death and coma
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pan B, Huang C, Fang X, Huang X, Li T. Noninvasive and sensitive optical assessment of brain death. J Biophotonics. 2019 Mar;12(3):e201800240. doi: 10.1002/jbio.201800240. Epub 2018 Dec 13.
PubMed 30379409
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy With Protocol at Varied Fraction of Inspired O2
- ClinicalTrials.gov ID
- NCT04623294
- Acronym / sponsor ID
- NIRS for brain death and coma
- Conditions
- Brain Death, Coma
- Keywords
- Brain death, Deep coma, Oxygen metabolism, Near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 10 Nov 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Nov 2020 (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 assess brain death and deep coma with the self-made near infrared spectroscopy (NIRS) instrument. The investigators used the noninvasive method to monitor the Δ[HbO2] (the concentration changes in oxy-hemoglobin) and Δ[Hb] (the concentration changes in deoxy-hemoglobin) in the region around the forehead of medically evaluated participating patients and healthy subjects. 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, while deep coma is a profound state of unconsciousness associated with depressed cerebral activity. Timely distinguishing the two states is crucial for saving patients. The noninvasive, sensitive, universally available, and timely ancillary method to assess brain death and deep coma has not been established. This study aims to explore a noninvasive and straightforward way in brain death and deep coma online assessment. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy instrument attached on the forehead of participators. A multiple-phase protocol at varied fraction of inspired O2(FIO2) were utilized during the assessment. Then the investigators compared the multiple physiological parameters changes among different groups at different FIO2.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Brain death patients for HLH Oxygen | – | Procedure: Oxygen supply of high-low-high procedureBrain-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 the NIRS instrument for hemodynamic parameter. |
| Brain death patients for LHL Oxygen | – | Procedure: Oxygen supply of low-high-low procedureBrain-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 the NIRS instrument for hemodynamic parameter. |
| Deep coma patients for HLH Oxygen | – | Procedure: Oxygen supply of high-low-high procedureDeep coma 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 the NIRS instrument for hemodynamic parameter. |
| Deep coma patients for LHL Oxygen | – | Procedure: Oxygen supply of low-high-low procedureDeep coma 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 the NIRS instrument for hemodynamic parameter. |
| Healthy people for HLH Oxygen | – | Procedure: Oxygen supply of high-low-high procedureHealthy 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 procedureHealthy 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. Hired from Intensive Care Center of Sichuan Provincial People's Hospital，Shanghai Xinhua Hospital and Tianjin Huanhu Hospital
Key inclusion criteria (3 listed)
- Patients who have had brain death or serious brain trauma.
- Patients who have deep coma with autonomous respiration according to GCS coma Scale
- 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.
- AIDS, Active Hepatitis, Tuberculosis, Syphilis
- Patients who regularly take anticoagulants, antiplatelet drugs
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). Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead to detect the changes of hemodynamic parameters. | Procedure or surgery | Brain death patients for HLH Oxygen, Deep coma 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). Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead to detect the changes of hemodynamic parameters. | Procedure or surgery | Brain death patients for LHL Oxygen, Deep coma patients for LHL 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 10 Nov 2020.
- Background: PubMed 30379409Pan B, Huang C, Fang X, Huang X, Li T. Noninvasive and sensitive optical assessment of brain death. J Biophotonics. 2019 Mar;12(3):e201800240. doi: 10.1002/jbio.201800240. Epub 2018 Dec 13.
Related trials for Brain Death
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Not yet recruitingObservational study
Brain-based Prediction of the Dying Duration in Humans After Withdrawal of Life Sustaining Therapies to Inform Donation After Circulatory Death
Organ Donation After Circulatory Death
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingPhase 2
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Coma, 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 3 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 10 Nov 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT04623294, which also lists 1 linked publication.
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 10 Nov 2020.