Multimodal Neurological Monitoring Strategy After Receiving ECPR
NCT ID: NCT06711016
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
654 participants
INTERVENTIONAL
2024-12-01
2028-07-30
Brief Summary
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Therefore multimodal neuromonitoring may be a valuable tool for detecting brain injury in patients with extracorporeal membrane oxygenation and providing early intervention guidance.
The aim of this study is to test whether multimodal neuromonitoring will improve 30-day survival with a favorable neurologic outcome in ECPR patients with a refractory OHCA.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
The experimental group：The Vm will maintained between 56-85 cm/s, Vd\>30cm/s，PI \<1.2, the cerebral oxygen saturation (rSO2) in the brain region will maintained between 60%-70%, ONSD\<5.5mm, and the pathological state will be monitored with EEG by regulating the ECMO parameters, temperature treatment, ventilation, vasoactive agent, sedative and antiepileptic drug et al. if necessary. The rest were monitored and treated with the control group.
TREATMENT
SINGLE
Study Groups
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multimodal monitoring strategy
These include TCD to monitor cerebral blood perfusion levels, NIRS to monitor oxygen saturation levels in brain regions, ONSD to evaluate cerebral edema, and continuous quantitative EEG to monitor brain function to assess prognosis. Among them, The Vm will maintained between 56-85 cm/s, Vd\>30cm/s，PI\<1.2, the cerebral oxygen saturation (rSO2) in the brain region will maintained at 55%-75%, ONSD \<5.5mm, and the pathological state will be monitored with EEG.
fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc
ECMO flow, IABP , ventilator support parameters, temperature management level and time
control
SPO2 between 92 and 98%, MAP ≥ 65 mmHg, Hb ≥ 7 g/dL, pH 7.35 to 7.45, Pco2 between 40-45 mmHg， Routine fluid resuscitation, dehydration and intracranial pressure reduction, ECMO circulatory flow adjustment, temperature management, ventilator-supported ventilation, coronary angiography if coronary causes are suspected.
fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc
ECMO flow, IABP , ventilator support parameters, temperature management level and time
Interventions
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fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc
ECMO flow, IABP , ventilator support parameters, temperature management level and time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Witnessed OHCA
3. Initially presenting with VF/VT or who have been administered an AED-shock
4. Bystander CPR
5. No flow time (time from CA to CPR) was less than 5 min
6. Fail to achieve sustained ROSC within 15 minutes
Exclusion Criteria
2. Terminal heart failure (NYHA III or IV), severe pulmonary disease (COPD Gold III or IV), oncological disease,
3. Pregnancy
4. Bilateral femoral bypass surgery
5. Pre arrest Cerebral Performance Category (CPC) score of 3 or 4
6. Multiple trauma (Injury Severity Score\>15)
7. Estimated that cannulation will start 90 minutes after the initial arrest.
18 Years
75 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Second Affiliated Hospital of Zhengzhou University
OTHER
Qilu Hospital of Shandong University
OTHER
Responsible Party
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Feng Xu
Professor
Principal Investigators
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Yuguo Chen, MD. PhD
Role: STUDY_CHAIR
Qilu Hospital, Shandong University
Locations
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Qilu Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Feng Xu, MD. PhD
Role: backup
Other Identifiers
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KYLL-202409-012-1
Identifier Type: -
Identifier Source: org_study_id