Xiaowei Li1, Jingze Li2, Xuehui Yang3, Zhaosheng Sun3, Jinrong Zhang3, Wangmiao Zhao3, Shuzhi Dong4, Cong Li4, Yanqiao Ye3, Jianchao Chen3, Yongqian Li3, Yi Xiang3, Jianhui Mao3, Guangjie Li3, Hong Guo3, Wenchao Zhang3, Hao Guo3, Yazhao Zhang3, Mingzhe Zhang3, Wanzeng Zhang3, Zhanyi Xu3, Baoshuai Zhao3, Jianhui Wei3, Gengshui Zhao3, Ronghua Ma3, Xiuzhi Shen3, Chunyan Ge3, Cunling Zheng3, Shang Li3, Yan Wang3. 1. Department of Neurosurgery, Harrison International Peace Hospital (Hengshui City People's Hospital), Affiliated Hospital of Hebei Medical University, Renmin East Road, Hengshui City, Hebei Province, People's Republic of China. Electronic address: lxwljz@163.com. 2. Clinical Medicine Specialty of the First Clinical Medical College, Hebei North University, Changqing Road, Qiaoxi District, Zhangjiakou City, Hebei Province, People's Republic of China. 3. Department of Neurosurgery, Harrison International Peace Hospital (Hengshui City People's Hospital), Affiliated Hospital of Hebei Medical University, Renmin East Road, Hengshui City, Hebei Province, People's Republic of China. 4. Department of Hyperbaric Medicine, Harrison International Peace Hospital (Hengshui City People's Hospital), Affiliated Hospital of Hebei Medical University, Renmin East Road, Hengshui City, Hebei Province, People's Republic of China.
Abstract
BACKGROUND: Prognosis of spontaneous intracerebral hemorrhage (ICH) remains poor worldwide. AIMS OF THE STUDY: To investigate the effect and optimal protocol for hyperbaric-oxygen therapy (HBOT), and reduce incidence of upper gastrointestinal bleeding (UGIB) in ICH. METHODS: This prospective, randomized, controlled trial included 565 patients with acute severe ICH. Participants were randomly assigned to a sham-control group (Group A) and four intervention groups: Groups B and C with 2.0 atmospheres absolute (ATA) pressure and HBOT exposure for 60 or 90 sessions, respectively; and Groups D and E with 1.5 ATA for 60 or 90 sessions, respectively. All patients received emergency craniotomy with hematoma evacuation. Outcome measures were modified Barthel Index (MBI) and modified Rankin Scale (mRS) scores, mortality rates at follow-up six months. UGIB rates were assessed as potential side effect. RESULTS: In four intervention groups, MBI and mRS scores were all significantly improved, and mortality rates were all significantly decreased compared with Group A (all p < 0.005). UGIB rates were 39.25, 60.00, 64.49, 36.79, and 34.26% in Groups A, B, C, D, and E, respectively. UGIB rates in Groups B and C were significantly increased compared with Groups A, D and E (all p < 0.005). None of UGIB were clinically significant. CONCLUSIONS:HBOT significantly improves survival and functional outcomes of ICH. HBOT at 1.5 and 2.0 ATA had the same beneficial effect. A pressure of 1.5 ATA and 60 HBOT exposures represents an optimal protocol for HBOT. Further studies are needed to optimize the protocol per specific patient.
RCT Entities:
BACKGROUND: Prognosis of spontaneous intracerebral hemorrhage (ICH) remains poor worldwide. AIMS OF THE STUDY: To investigate the effect and optimal protocol for hyperbaric-oxygen therapy (HBOT), and reduce incidence of upper gastrointestinal bleeding (UGIB) in ICH. METHODS: This prospective, randomized, controlled trial included 565 patients with acute severe ICH. Participants were randomly assigned to a sham-control group (Group A) and four intervention groups: Groups B and C with 2.0 atmospheres absolute (ATA) pressure and HBOT exposure for 60 or 90 sessions, respectively; and Groups D and E with 1.5 ATA for 60 or 90 sessions, respectively. All patients received emergency craniotomy with hematoma evacuation. Outcome measures were modified Barthel Index (MBI) and modified Rankin Scale (mRS) scores, mortality rates at follow-up six months. UGIB rates were assessed as potential side effect. RESULTS: In four intervention groups, MBI and mRS scores were all significantly improved, and mortality rates were all significantly decreased compared with Group A (all p < 0.005). UGIB rates were 39.25, 60.00, 64.49, 36.79, and 34.26% in Groups A, B, C, D, and E, respectively. UGIB rates in Groups B and C were significantly increased compared with Groups A, D and E (all p < 0.005). None of UGIB were clinically significant. CONCLUSIONS: HBOT significantly improves survival and functional outcomes of ICH. HBOT at 1.5 and 2.0 ATA had the same beneficial effect. A pressure of 1.5 ATA and 60 HBOT exposures represents an optimal protocol for HBOT. Further studies are needed to optimize the protocol per specific patient.
Authors: Kathryn N Kearns; Natasha Ironside; Min S Park; Bradford B Worrall; Andrew M Southerland; Ching-Jen Chen; Dale Ding Journal: Neurocrit Care Date: 2021-08-02 Impact factor: 3.210