An observational study in Brain Death and Coma, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by Chinese Academy of Medical Sciences · Observational
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.
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.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's planned enrollment of 75 is close to the median of 80 across 33 observational studies indexed under Brain Death.
Browse Brain Death studies →Chinese Academy of Medical Sciences is the lead sponsor of 237 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult individuals of any gender. Hired from Intensive Care Center of Sichuan Provincial People's Hospital，Shanghai Xinhua Hospital and Tianjin Huanhu Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: 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 low-high-low procedure. During the procedures, the Δ\[Hb\] and Δ\[HbO2\] time courses were collected by the NIRS instrument for hemodynamic parameter.
Procedure: Oxygen supply of low-high-low procedure
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.
Procedure: Oxygen supply of high-low-high procedure
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.
Procedure: 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 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
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 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.
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.
Δ[HbO2]
The changes of oxyhemoglobin concentrations in prefrontal cortex.
Time frame: 1 day during the whole experiment
Δ[Hb]
The changes of deoxyhemoglobin concentrations in prefrontal cortex.
Time frame: 1 day during the whole experiment
Heart rate
Heart rate of patient recorded by bed-side physiological monitor.
Time frame: 1 day during the whole experiment
Blood pressure
Blood pressure of patient recorded by bed-side physiological monitor.
Time frame: 1 day during the whole experiment
Start is estimated for Nov 2020; primary completion for Mar 2021, 4 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese Academy of Medical Sciences →