Diseases requiring adjuvant treatment with temperature control
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with acute ischemic stroke meet the following conditions: 1) Age =18 years old; 2) Anterior circulation vessel occlusion confirmed by CTA/MRA/DSA (ICA, MCA M1 or M2 segment); 3) NCCT/MRI-DWI ASPECTS score 3-5 or CTP core infarction volume (rCBF <30%) 50-150ml; 4) eTICI= 2B 50 after EVT treatment; 5) NIHSS score =10 before EVT treatment. 2. Patients with subarachnoid hemorrhage meet the following conditions: 1) Age =18 years old; 2) CT confirmed subarachnoid hemorrhage; 3) mFisher grade 2-4; 4) WFNS grade II-V. 3, patients with cerebral hemorrhage, meet the following conditions: 1) Age =18 years old; 2) CT confirmed cerebral hemorrhage, acute (within 72 hours) or subacute (3 days to 3 weeks); 3) Glasgow Coma Scale (GCS) < 15 points. 4. Patients with perioperative temperature control shall meet the following conditions: 1) Age =18 years old; 2) General anesthesia or combined anesthesia; 3) The duration of anesthesia is expected to exceed 2 hours.
Exclusion criteria
Exclusion criteria: 1) Serious infectious diseases, serious coagulopathy, suffering from serious heart, lung and other diseases; 2) Infection in the puncture areaabnormal anatomy of the puncture site; 3) Allergic to heat exchange catheters; 4) Serious hepatic and renal insufficiency; 5) Pregnant and lactating women and those who plan to get pregnant within one year; 6) Participants who participated in clinical trials of any drug and/or medical device within 3 months prior to enrollment; 7) The researcher considers that there are any other factors that are not suitable for inclusion or affect the participant's participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of target temperature management; | — |
Secondary
| Measure | Time frame |
|---|---|
| Successful cooling rate;Mean hourly cooling temperature(min);Mean cooling time;Stably maintain the target temperature duration;Target temperature maximum deviation value;Target temperature mean deviation value;Successful warming rate;Mean hourly warming temperature (min);Mean warming time;Device Success rate;Device operating performance evaluation;Incidence of complications;The incidence of adverse events; | — |
Countries
China
Contacts
Xuanwu Hospital of Capital Medical University