Multimodal Neurological Monitoring Strategy After Receiving ECPR (MNM-ECPR)

Shandong University

Status: Not yet enrolling

Conditions: Cardiac Arrest

Treatments: Other: fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc

Study type: Interventional

Funder types: Other

Identifiers

NCT06711016

KYLL-202409-012-1

Details and patient eligibility

About

Neurological injury remains an important cause of morbidity and mortality in patients with ECPR. At present, the results of three prospective randomized controlled studies on ECPR are inconsistent, and it is inconclusive whether ECPR can improve the neurological outcomes of patients with refractory cardiac arrest. Several study found that extracorporeal membrane oxygenation nonsurvivors can lead toacute brain injury.Further research with a systematic neurologic monitoring is necessary to define the timing of acute brain injury in patients with extracorporeal membrane oxygenation.Moreover, brain injury that occurs during extracorporeal membrane oxygenation therapy is not easy to detect in time because of the use of analgesics, sedatives, and muscle relaxants. Surprisingly, little attention has been paid to the role of cerebral perfusion and oxygenation. Moreover,the features of cerebrovascular pathophysiology and optimal management strategies are still vague.

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.

Enrollment: 654 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presumed or known to be 18-75 years old
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

1. ROSC with sustained hemodynamic recovery within 15 minutes
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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654 participants in 2 patient groups

multimodal monitoring strategy

Experimental group

Description:

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.

Treatment:

Other: fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc

control

Active Comparator group

Description:

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.

Treatment:

Other: fluid resuscitation, vasoactive drug dose,hemoglobin transfusion,sedative analgesic muscle relaxant drugs, antiepileptic drugs, etc