Normobaric oxygen therapy

  • 文章类型: Clinical Trial Protocol
    氧气对细胞能量代谢至关重要。神经元特别容易缺氧。中风发作后不久增加氧气供应可以保留缺血半暗带,直到发生血运重建。
    PROOF研究了在急性颅内前循环闭塞的血管内血管内血运重建之前,症状发作/通知后6小时内使用常压氧(NBO)治疗脑保护性桥接。
    随机化(1:1),标准治疗控制,开放标签,盲点,多中心适应性IIb期试验。
    主要结果是从基线到24小时的缺血核心生长(mL)(意向治疗分析)。次要疗效结果包括NIHSS从基线到24小时的变化,90天的mRS,认知和情感功能,和生活质量。安全性结果包括死亡率,颅内出血,和呼吸衰竭。将进行成像和血液生物标志物的探索性分析。
    使用适应性设计和中期分析,每臂80名患者,多达456名参与者(每个手臂228名)需要80%的功率(单侧α0.05)来检测平均减少6.68mL的缺血性核心生长,假设标准偏差为21.4毫升。
    通过在早期时间窗内登记血管内血栓切除术候选者,该试验复制了NBO表现出有益效果的临床前研究的见解,即在短暂的暂时缺血期间早期开始近100%的吸入氧。24小时随访影像学的主要结果评估可减少因停药和早期临床混杂因素(如延迟拔管和吸入性肺炎)引起的变异性。
    ClinicalTrials.gov:NCT03500939;EudraCT:2017-001355-31。
    UNASSIGNED: Oxygen is essential for cellular energy metabolism. Neurons are particularly vulnerable to hypoxia. Increasing oxygen supply shortly after stroke onset could preserve the ischemic penumbra until revascularization occurs.
    UNASSIGNED: PROOF investigates the use of normobaric oxygen (NBO) therapy within 6 h of symptom onset/notice for brain-protective bridging until endovascular revascularization of acute intracranial anterior-circulation occlusion.
    UNASSIGNED: Randomized (1:1), standard treatment-controlled, open-label, blinded endpoint, multicenter adaptive phase IIb trial.
    UNASSIGNED: Primary outcome is ischemic core growth (mL) from baseline to 24 h (intention-to-treat analysis). Secondary efficacy outcomes include change in NIHSS from baseline to 24 h, mRS at 90 days, cognitive and emotional function, and quality of life. Safety outcomes include mortality, intracranial hemorrhage, and respiratory failure. Exploratory analyses of imaging and blood biomarkers will be conducted.
    UNASSIGNED: Using an adaptive design with interim analysis at 80 patients per arm, up to 456 participants (228 per arm) would be needed for 80% power (one-sided alpha 0.05) to detect a mean reduction of ischemic core growth by 6.68 mL, assuming 21.4 mL standard deviation.
    UNASSIGNED: By enrolling endovascular thrombectomy candidates in an early time window, the trial replicates insights from preclinical studies in which NBO showed beneficial effects, namely early initiation of near 100% inspired oxygen during short temporary ischemia. Primary outcome assessment at 24 h on follow-up imaging reduces variability due to withdrawal of care and early clinical confounders such as delayed extubation and aspiration pneumonia.
    UNASSIGNED: ClinicalTrials.gov: NCT03500939; EudraCT: 2017-001355-31.
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  • 文章类型: Journal Article
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  • 文章类型: Case Reports
    Pneumocephalus is defined as an accumulation of air or gas in the intracranial space. It is a common complication after skull surgery or craniofacial trauma, sometimes also caused by gas-producing organisms in the context of an infection, and reported with cerebrospinal fluid draining procedures. Here we report a case of a large intraventricular tension pneumocephalus after removal of an external ventricular drain in a patient with subarachnoid hemorrhage. The acute management included therapy with normobaric oxygen. Despite the large volume of trapped air and its diffuse distribution inside the skull and spine, therapy with 100% normobaric oxygen appears to be safe and efficient for a rapid improvement of the patient\'s symptoms and the neuroradiological imaging.
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  • 文章类型: Journal Article
    一氧化碳(CO)是燃烧的气体产物,认为剧毒。长期接触一氧化碳是造成一半以上致命中毒的原因,也是西方国家中毒的主要原因之一。我们旨在比较高压氧(HBO)与常压氧(NBO)在一氧化碳中毒(COP)中的治疗效果。我们独立检索了国家医学图书馆的Medline(PubMed™),ScienceDirect™,和Scielo™从1989年到2017年发表的任何相关研究,使用以下关键词:高压治疗,高压氧,常压疗法,一氧化碳中毒,碳氧血红蛋白,霍尔丹效应。我们分析了表明HBO或NBO有效性的研究。此外,我们搜索了与缔约方会议相关的研究;包括历史,流行病学(危险因素,发病率,人口统计),病理生理学,临床表现,诊断,和治疗。共找到68篇文章,其中16个涉及HBO或NBO或两者兼而有之。12项建议将HBO作为COP的首选治疗方法;四项研究表明,由于NBO在急诊科(ED)的成本效益和可用性,NBO是一种适当的治疗方法。多项研究表明,HBO在中度至高风险COP情况下有效,作为避免后遗症的首选疗法,尤其是神经学。由于其成本效益,NBO可以被认为是一种合理的替代方案。不同治疗干预措施的可用性和理解对于ED和重症监护病房COP患者的管理至关重要。
    Carbon monoxide (CO) is a gas product of combustion, considered highly poisonous. Prolonged CO exposure is responsible for more than half of fatal poisonings and is also one of the leading causes of poisoning in Western countries. We aimed to compare the effectiveness of therapy with hyperbaric oxygen (HBO) versus normobaric oxygen (NBO) in the setting of carbon monoxide poisoning (COP). We independently searched the National Library of Medicine\'s Medline (PubMed™), ScienceDirect™, and Scielo™ for any relevant studies published from 1989 to 2017, using the following keywords: hyperbaric therapy, hyperbaric oxygenation, normobaric therapy, carbon monoxide poisoning, carboxyhemoglobin, Haldane effect. We analyzed the studies that suggested the effectiveness of HBO or NBO. Also, we searched for studies related to COP; including history, epidemiology (risk factors, incidence, demographics), pathophysiology, clinical manifestations, diagnosis, and treatment. Sixty-eight articles were found, sixteen of which dealt with either HBO or NBO or both. Twelve suggested HBO as the treatment of choice in COP; four studies indicated that NBO was an adequate treatment due to its cost-effectiveness and availability in the emergency department (ED). HBO has been shown in several studies to be effective in moderate to high-risk COP situations, being the therapy of choice to avoid sequelae, especially neurologically. NBO can be considered as a reasonable alternative due to its cost-effectiveness. The availability and understanding of different therapeutic interventions are critical in the management of patients with COP in ED and the Critical Care unit.
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  • 文章类型: Journal Article
    OBJECTIVE: Although Hyperbaric oxygen therapy (HyperBOT) attract our attention successfully these days, it is still full of controversy on the treatment of acute stroke. The aim of this study is to assess the potential long-term neurological consequences and safety of using HyperBOT on intracerebral hemorrhage (ICH) in the diabetics.
    METHODS: In this prospective, randomized controlled trial, 79 diabetes patients suffering from acute ICH were randomized to treat for 60 min in a monoplace hyperbaric chamber pressurized with pure oxygen to 2.5-atm absolute (ATA) in the HyperBOT group or 1.5 ATA in the normobaric oxygen therapy (NormBOT) group, which was performed as control. Both short-term and long-term neurological consequences were studied and compared in each group on National Institutes of Health Stroke Scale [NIHSS], Barthel Index, modified Rankin Scale [mRS] and Glasgow Outcome Scale [GOS]. The related complications or side-events of all patients were recorded as well at the final follow-up of six months after onset.
    RESULTS: No distinct difference was observed between each group at one month follow-up. However, in the long-term follow-up of six months, a higher frequency of patients in the HyperBOT group resulted into good outcome with a relative high neurological consequence compared with the NormBOT group (Barthel Index: 85.1% versus 65.6%, P = 0.080; mRS: 89.4% versus 68.8%, P = 0.045; GOS: 83.0% versus 62.5%, P = 0.073; NIHSS: 80.9% versus 56.2%, P = 0.035).
    CONCLUSIONS: Early HyperBOT was found to be safe and effective with regards to the long-term neurological outcome of diabetic patients suffering from ICH.
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  • 文章类型: Journal Article
    BACKGROUND: To evaluate the effect of high-dose intravenous steroids, as well as normobaric oxygen therapy, in the management of recent onset non-arteritic anterior ischemic optic neuropathy (NAION).
    METHODS: Ninety eyes of 90 patients diagnosed with NAION within 14 days of onset were included in this single masked randomized clinical trial. Thirty patients were randomized into each set as group 1 (control), group 2 (steroids), and group 3 (oxygen). Controls received placebo; group 2 received methylprednisolone 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1 mg/kg/day; group 3 received 100 % normobaric oxygen with mask, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks. Functional and structural outcomes were analyzed at 1 and 6 months following treatment. Best corrected visual acuity (BCVA) was the main outcome measure, and mean deviation (MD) of visual field (VF) test and peripaillary retinal nerve fiber layer thickness (PRNFLT) were secondary outcome measures.
    RESULTS: The mean BCVA at the time of presentation was 1.02 ± 0.63, 1.05 ± 0.7, and 0.76 ± 0.5 LogMAR in groups 1, 2, and 3, respectively (p = 0.293); corresponding values were 0.8 ± 0.45, 0.84 ± 0.45, and 0.58 ± 0.4 at month 1 (p = 0.127, 0.19, and 0.168, respectively). BCVA improved to 0.71 ± 0.46, 0.73 ± 0.36, and 0.59 ± 0.41 LogMAR at the 6-month follow-up point (p = 0.039, 0.048, and 0.195, respectively). The mean deviation (MD) at the time of presentation was 19.26 ± 7.02, 20.51 ± 4.68, and 19.3 ± 7.17 in the control, steroid, and oxygen groups, respectively (p = 0.65). Corresponding values at month 1 were 20.26 ± 8.52, 19.52 ± 7.08, and 18.3 ± 7.45, (p = 0.656); and at month 6 were 18.42 ± 8.17, 17.66 ± 6.44 and 16.53 ± 6.32, respectively (p = 0.635). PRNFLT at presentation was 166 ± 57, 184 ± 57, and 193 ± 65 micrometer in the control, steroid, and oxygen groups, respectively (p = 0.265); which decreased to 73 ± 11, 87 ± 26, and 79 ± 19 at the final foll-w up (all p < 0.001). There were no statistically significant differences between the three groups in terms of final visual function and structure.
    CONCLUSIONS: The lack of demonstrable improvement in the structural and functional outcomes of NAION with high-dose IV steroids, or normobaric oxygen, in this randomized controlled trial calls into question the administering of systemic steroid or normobaric oxygen in this condition.
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  • 文章类型: Journal Article
    Background Impaired oxygen utilization and cerebrovascular dysfunction are implicated in migraine. High-flow oxygen is effective in cluster headache and has shown promise in animal models of migraine, but has not been adequately studied in patients with migraine. Methods In this randomized, crossover-design, placebo-controlled trial, adult migraineurs self-administered high-flow oxygen or medical air at 10-15 l/min via face mask in blinded fashion starting soon after symptom onset for 30 minutes, for a total of four migraine attacks. Participants recorded the severity of headache, nausea, and visual symptoms on visual analog scales periodically up to 60 minutes. Results We enrolled 22 individuals (mean age 36 years, 20 women) who self-treated 64 migraine attacks (33 oxygen, 31 air). The pre-specified primary endpoint (mean decrease in pain score from baseline to 30 minutes) was 1.38 ± 1.42 in oxygen-treated and 1.22 ± 1.61 in air-treated attacks ( p = 0.674). Oxygen therapy resulted in relief (severity score 0-1) of pain (24% versus 6%, p = 0.05), nausea (42% versus 23%, p = 0.08) and visual symptoms (36% versus 7%, p = 0.004) at 60 minutes. Exploratory analysis showed that in moderately severe attacks (baseline pain score <6), pain relief was achieved in six of 13 (46%) oxygen versus one of 15 (7%) air ( p = 0.02). Gas therapy was used per protocol in 91% of attacks. There were no significant adverse events. Conclusion High-flow oxygen may be a feasible and safe strategy to treat acute migraine. Further studies are required to determine if this relatively inexpensive, widely available treatment can be used as an adjunct or alternative migraine therapy.
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  • 文章类型: Journal Article
    Normobaric oxygen (NBO) reduces infarction at 24-48 h in experimental models of focal cerebral ischemia. However, to be clinically relevant, longer term safety and efficacy must be explored. Here, we assessed the effects of NBO on glial activation, neurovascular recovery, and behavioral outcomes at 2 weeks after transient focal ischemia in rats. 100 min transient focal ischemia was induced by intraluminal occlusion of the middle cerebral artery in adult male Sprague-Dawley rats. Animals were randomized into sham, controls or 85\'NBO started 15 min after ischemic onset. Infarct volumes and behavioral outcomes were blindly quantified. Immunohistochemistry was used to examine the effects of NBO on glial activation and neurovascular responses. After 2 weeks of reperfusion the infarct volume was marked reduced in animals subjected to NBO. They also had better outcomes in forelimb placement test and in body-swing test and weight loss reduction. After 14 days, NBO decreased expression of Iba1, a marker of activated microglia, and GFAP, a marker of activated astrocytes. NBO treatment had no detectable effect on angiogenesis. These results suggest that protective effects of NBO may persist for up to 2 weeks post-stroke.
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