NCT06016751

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

July 19, 2023

Last Update Submit

August 23, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • intracranial blood flow

    Mean intracranial middle cerebral artery blood flow velocity and pulsatility index measured using ultrasound Doppler in enrolled patients.

    Day 1,Day 3,Day 5

  • Paroxysmal sympathetic excitation

    Use of the Paroxysmal Sympathetic Nerve Score to assess paroxysmal sympathoexcitatory performance in patients.

    Day 1,Day 3,Day 5

Study Arms (1)

cranial damage

Our study was a prospective observational study which included only a group of patients who were diagnosed with acute craniocerebral injury.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Definite craniocerebral injury, surgically treated and transferred to ICU.

You may qualify if:

  • Craniocerebral injury patients;
  • The middle cerebral artery blood flow spectrum can be clearly displayed with a bedside TCD;

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wei Du

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Brain InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 30, 2023

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations