Brain-injuryNCT06016751
Relationship Between Intracranial Blood Flow and Peripheral Perfusion in Patients With Craniocerebral Injury
An observational study of Brain-injury and Intracranial; Blood Vessel, Injury, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Neurocritical care is a major branch in the field of critical care medicine, and more than 50% of the neurocritical care patients in the Tibet Autonomous Region People's Hospital (TARPH) are in neurocritical care, of which cranial damage accounts for about 30%, and paroxysmal sympathetic hyperexcitability syndrome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain-injury, Intracranial; Blood Vessel, Injury
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Definite craniocerebral injury, surgically treated and transferred to ICU.
Who may be able to join
- Craniocerebral injury patients;
- The middle cerebral artery blood flow spectrum can be clearly displayed with a bedside TCD;
Who cannot join
- Age Under 18 years;
- history of cardiovascular disease such as coronary artery disease, heart failure, or atrial fibrillation;
- presence of severe valvular disease or ejection fraction (EF) <30%;
- chronic lung disease;
- chronic liver failure or renal insufficiency;
- persons with co-morbidities of malignant neoplasms;
Show all 12Show fewer
- persons who had co-morbidities with acute and chronic infectious diseases prior to craniocerebral injuries;
- women who were pregnant and breastfeeding;
- history of psychiatric disorders;
- history of drug abuse or alcohol misuse;
- history of β-blockers;
- co-morbidities with spinal cord injuries; and persons who had died or been discharged from hospital within 1 week of hospitalization or who had not been able to obtain a clear image with ultrasonography.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Intracranial Blood Flow and Peripheral Perfusion in Patients With Craniocerebral Injury Assessed by Doppler Ultrasound and Prognostic Assessment
Neurocritical care is a major branch in the field of critical care medicine, and more than 50% of the neurocritical care patients in the Tibet Autonomous Region People's Hospital (TARPH) are in neurocritical care, of which cranial damage accounts for about 30%, and paroxysmal sympathetic hyperexcitability syndrome (PSH) after traumatic brain injury（TBI）is a common complication, which affects the cardiorespiratory and cerebral functions to varying degrees, and optimizing the cerebral perfusion and oxygenation supply is the key point in the treatment of TIB, and the maintenance of the cerebral homeostasis and the functional homeostasis is currently an international hotspot for treatment. Maintaining cerebral homeostasis and body function homeostasis is an international hotspot in the treatment of TIB. This study intends to elaborate on the relationship between PSH and Intracranial blood flow in patients with TBI, as well as the effect of anti-stress treatment on Intracranial blood flow. Implementation Patients with brain injury admitted to our department from January 2021 to January 2022 were included. Non-invasive transcranial Doppler ultrasound was applied to measure cerebral blood flow, non-invasive local cerebral oxygen saturation monitor to measure local cerebral oxygen saturation, and an electroencephalography bispectrometer to measure BIS score to quantify the depth of sedation during the experimental process. Bedside ultrasound monitored the right heart function and lung water status, and the data of each monitoring index were monitored and recorded throughout the whole process, and the relationship between concomitant PSH and Intracranial blood flow in TBI patients was found according to the statistical analysis. Ultimately, to achieve the control of TBI complications and improve patient rescue. To expect to achieve the purpose of improving the prognosis of TBI patients.
- Conditions
- Brain-injury, Intracranial; Blood Vessel, Injury
- Medical subject headings
- Brain Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cranial damage | Our study was a prospective observational study which included only a group of patients who were diagnosed with acute craniocerebral injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial blood flow
Mean intracranial middle cerebral artery blood flow velocity and pulsatility index measured using ultrasound Doppler in enrolled patients.
Measured: Day 1,Day 3,Day 5
Paroxysmal sympathetic excitation
Use of the Paroxysmal Sympathetic Nerve Score to assess paroxysmal sympathoexcitatory performance in patients.
Measured: Day 1,Day 3,Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain-injuryStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016751
- Sponsor's protocol ID
- YLong
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Intracranial Blood Flow and Peripheral Perfusion in Patients With Craniocerebral Injury Assessed by Doppler Ultrasound and Prognostic Assessment
- ClinicalTrials.gov ID
- NCT06016751
- Acronym / sponsor ID
- YLong
- Conditions
- Brain-injury, Intracranial; Blood Vessel, Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 30 Aug 2023 (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.
Neurocritical care is a major branch in the field of critical care medicine, and more than 50% of the neurocritical care patients in the Tibet Autonomous Region People's Hospital (TARPH) are in neurocritical care, of which cranial damage accounts for about 30%, and paroxysmal sympathetic hyperexcitability syndrome (PSH) after traumatic brain injury（TBI）is a common complication, which affects the cardiorespiratory and cerebral functions to varying degrees, and optimizing the cerebral perfusion and oxygenation supply is the key point in the treatment of TIB, and the maintenance of the cerebral homeostasis and the functional homeostasis is currently an international hotspot for treatment. Maintaining cerebral homeostasis and body function homeostasis is an international hotspot in the treatment of TIB. This study intends to elaborate on the relationship between PSH and Intracranial blood flow in patients with TBI, as well as the effect of anti-stress treatment on Intracranial blood flow. Implementation Patients with brain injury admitted to our department from January 2021 to January 2022 were included. Non-invasive transcranial Doppler ultrasound was applied to measure cerebral blood flow, non-invasive local cerebral oxygen saturation monitor to measure local cerebral oxygen saturation, and an electroencephalography bispectrometer to measure BIS score to quantify the depth of sedation during the experimental process. Bedside ultrasound monitored the right heart function and lung water status, and the data of each monitoring index were monitored and recorded throughout the whole process, and the relationship between concomitant PSH and Intracranial blood flow in TBI patients was found according to the statistical analysis. Ultimately, to achieve the control of TBI complications and improve patient rescue. To expect to achieve the purpose of improving the prognosis of TBI patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cranial damage | – | –Our study was a prospective observational study which included only a group of patients who were diagnosed with acute craniocerebral injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Definite craniocerebral injury, surgically treated and transferred to ICU.
Key inclusion criteria (2 listed)
- Craniocerebral injury patients;
- The middle cerebral artery blood flow spectrum can be clearly displayed with a bedside TCD;
Key exclusion criteria (12 listed)
- Age Under 18 years;
- history of cardiovascular disease such as coronary artery disease, heart failure, or atrial fibrillation;
- presence of severe valvular disease or ejection fraction (EF) <30%;
- chronic lung disease;
- chronic liver failure or renal insufficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intracranial blood flow
Time frame: Day 1,Day 3,Day 5
Mean intracranial middle cerebral artery blood flow velocity and pulsatility index measured using ultrasound Doppler in enrolled patients.
Paroxysmal sympathetic excitation
Time frame: Day 1,Day 3,Day 5
Use of the Paroxysmal Sympathetic Nerve Score to assess paroxysmal sympathoexcitatory performance in patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
Related trials for Brain-injury
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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-injury and Intracranial; Blood Vessel, Injury, run by Peking Union Medical College Hospital 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 12 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: finished, as of the sponsor's last update on 30 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
intracranial blood flow (time frame: Day 1,Day 3,Day 5). 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 30 Aug 2023.