Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy

NANot yet recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

May 31, 2021

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2025

Conditions
Hypothermia
Interventions
DEVICE

Artic Sun

"1. Induction phase A. Temperature using by esophageal or bladder thermometer. B. Application of a surface cooling device (Arctic Sun) C. Target temperature: 35 ± 0.5 °C D. Induction should be initiated as soon as possible after surgery (less than 6 hours)~2. Maintain phase A. Maintain duration : at least 72 hours and duration can be prolonged according to patient's clinical status B. Use the bedside shivering assessment scale (BSAS) and anti-shivering protocol C. Neuromuscular blocker can be used according to the discretion of the attending physician D. Lung-protective ventilation strategies including low-tidal volume are recommended E. Prophylactic antibiotics can be used to prevent pneumonia during hypothermia~3. Rewarming phase A. Rewarming rate: 0.05 - 0.1 ℃/hr (about 20 - 40 hours) to 37 ℃"

Trial Locations (1)

Unknown

Moon-Ku Han, Seongnam-si

All Listed Sponsors
collaborator

Bard Medical Division C.R. Bard Inc

UNKNOWN

lead

Seoul National University Hospital

OTHER

NCT04825418 - Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With Hemicraniectomy | Biotech Hunter | Biotech Hunter