scholarly journals Effect of hydrogen gas inhalation on patient QOL after hepatectomy: protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Masaki Kaibori ◽  
Hisashi Kosaka
Keyword(s):  
Clinical Trial ◽  
Medical Care ◽  
Rating Scale ◽  
Ischemia Reperfusion ◽  
Hydrogen Gas ◽  
Trial Registration ◽  
Inhalation Therapy ◽  
Randomized Controlled ◽  
Gas Inhalation ◽  
Hydrogen Gas Inhalation

Abstract Introduction Molecular hydrogen had been considered inactive in vivo but is an antioxidant that selectively reduces highly toxic reactive oxygen species (ROS). Animal studies have reported that hydrogen gas inhalation helped alleviate cerebral and cardiac ischemia-reperfusion injuries. In humans, hydrogen inhalation therapy is presently approved as a treatment under Advanced Medical Care B in Japan (jRCTs031180352: limited to adult patients who suffered out-of-hospital cardiac arrest and are in a continuous coma) and its effectiveness is being examined in a clinical trial. The Japanese government has introduced the “Advanced Medical Care System” to promote the development of drugs and devices under governmental regulations. Advanced Medical Care B is a system designed for unapproved or off-label drugs or medical technologies used in a clinical trial setting. Hepatectomy is generally performed with repeated hepatic blood-flow occlusion and then reperfusion (ischemia and reperfusion). No report, however, has been made on ROS inhibition by hydrogen inhalation therapy or its effectiveness in post-hepatectomy patients. Hydrogen gas inhalation in the early stages after hepatectomy is anticipated to inhibit liver dysfunction by inhibiting ROS. Methods and analysis This study is a randomized, controlled, double-blind superiority trial, which will be conducted as a “specified clinical trial” in accordance with the Clinical Trials Act in Japan. Trial registration was prospectively completed before the first participant was enrolled. The subjects will be patients who will undergo hepatectomy and will be allocated randomly into group A with hydrogen gas inhalation or group B with air inhalation after hepatectomy. The study will examine if hydrogen gas inhalation improves QOL of post-hepatectomy patients. The primary endpoint is patient QOL (score of a 40-item quality of recovery questionnaire, QoR40) on postoperative day 3 and the secondary endpoints are QoR40s besides that on postoperative day 3, grade of postoperative complications (Clavien-Dindo score), level of pain (Numerical Rating Scale (NRS)), amount of dietary intake, liver function, inflammation level, 8-hydroxydeoxyguanosine (urinary 8-OHdG) level, and number of pedometer-assessed steps. Ethics and dissemination The study protocol has been approved by the Niigata University Central Review Board of Clinical Research. The findings of this study will be widely disseminated through peer-reviewed publications and conference presentations. Trial registration jRCTs 03220332. Registered on 21 January 2021

scholarly journals Effect of Hydrogen Gas Inhalation on Patient QOL After Hepatectomy: Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Masaki Kaibori ◽  
Hisashi Kosaka
Keyword(s):  
Clinical Trial ◽  
Medical Care ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Ischemia Reperfusion ◽  
Hydrogen Gas ◽  
Inhalation Therapy ◽  
Randomized Controlled ◽  
Gas Inhalation ◽  
Hydrogen Gas Inhalation

Abstract Introduction: Molecular hydrogen had been considered inactive in vivo but is an antioxidant that selectively reduces highly toxic reactive oxygen species (ROS). Animal studies have reported that hydrogen gas inhalation helped alleviate cerebral and cardiac ischemia-reperfusion injuries. In humans, hydrogen inhalation therapy is presently approved as a treatment under Advanced Medical Care B in Japan (jRCTs031180352: limited to adult patients who suffered out-of-hospital cardiac arrest and are in a continuous coma) and its effectiveness is being examined in a clinical trial. The Japanese government has introduced the “Advanced Medical Care System” to promote the development of drugs and devices under governmental regulations. Advanced Medical Care B is a system designed for unapproved or off-label drugs or medical technologies used in a clinical trial setting. Hepatectomy is generally performed with repeated hepatic blood-flow occlusion and then reperfusion (ischemia and reperfusion). No report, however, has been made on ROS inhibition by hydrogen inhalation therapy or its effectiveness in post-hepatectomy patients. Hydrogen gas inhalation in the early stages after hepatectomy is anticipated to inhibit liver dysfunction by inhibiting ROS.Methods and analysis: This study is a randomized, controlled, double-blind trial which will be conducted as a “specified clinical trial” in accordance with the Clinical Trials Act in Japan. The subjects will be patients who will undergo hepatectomy and will be allocated randomly into group A with hydrogen gas inhalation or group B with air inhalation after hepatectomy. The study will examine if hydrogen gas inhalation improves QOL of post-hepatectomy patients. The primary endpoint is patient QOL (score of a 40-item quality of recovery questionnaire, QoR40) on postoperative day 3 and the secondary endpoints are QoR40s besides that on postoperative day 3, grade of postoperative complications (Clavien-Dindo score), level of pain (NRS: Numerical Rating Scale), amount of dietary intake, liver function, inflammation level, 8-hydroxydeoxyguanosine (urinary 8-OHdG) level, and number of pedometer-assessed steps.Ethics and dissemination: The protocol has been approved by the Niigata University Central Review Board of Clinical Research. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration number: jRCTs No. 03220332. Approved on 21 January 2021.

Hydrogen Gas Inhalation Alleviates Radiation-Induced Bone Marrow Damage in Cancer Patients

2019 ◽  
Author(s):  
Shin-ichi Hirano ◽  
Yukimasa Aoki ◽  
Ryosuke Kurokawa ◽  
Xiao-Kang Li ◽  
Naotsugu Ichimaru ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Cancer Patients ◽  
Hydrogen Gas ◽  
Bone Marrow Damage ◽  
Radiation Induced ◽  
Gas Inhalation ◽  
Hydrogen Gas Inhalation

scholarly journals Efficacy and safety of Shi-style cervical manipulation therapy for treating acute and subacute neck pain: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mingcai Zhang ◽  
Guoqing Du ◽  
Congying Liu ◽  
Wei Li ◽  
Jiayu Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neck Pain ◽  
Clinical Observation ◽  
Rating Scale ◽  
Neck Disability Index ◽  
Trial Registration ◽  
Activity Measurement ◽  
Manipulation Therapy ◽  
Self Evaluation ◽  
Cervical Manipulation

Abstract Background Neck pain is a common clinical disease, which seriously affects people’s mental health and quality of life and results in loss of social productivity. Improving neck pain’s curative effect and reducing its recurrence rate are major medical problems. Shi’s manipulation therapy has unique advantages and technical features that aid in the diagnosis and treatment of neck pain. Compared with first-line non-steroidal anti-inflammatory drug (NSAID) treatment of neck pain, Shi’s cervical manipulation lacks the relevant research basis of therapeutic advantage, safety, and satisfaction for treating acute and subacute neck pain. Herein, we aim to confirm our hypothesis in a clinical trial that the safety and efficacy of Shi’s cervical manipulation will be more effective, safer, and more satisfactory than NSAIDs to treat acute and subacute neck pain. Methods In this multicenter, positive-controlled, randomized clinical trial, traditional analgesic drug (NSAID) is used to evaluate and show that Shi’s manipulation is more effective, safe, and satisfactory for treating acute and subacute neck pain. Overall, 240 subjects are randomly divided into the trial and control groups, with both groups treated by the corresponding main intervention method for up to 12 weeks. Clinical data will be collected before the intervention and immediately after the first treatment; at 3 days and 1, 2, 4, 8, and 12 weeks after the intervention; and at 26 and 52 weeks after treatment follow-up of clinical observation index data collection. The clinical observation indices are as follows: (1) cervical pain is the primary observation index, measured by Numerical Rating Scale. The secondary indices include the following: (2) cervical dysfunction index, measured by patient self-evaluation using cervical Neck Disability Index; (3) cervical activity measurement, measured by the cervical vertebra mobility measurement program of Android mobile phone system; (4) overall improvement, measured by patient self-evaluation with SF-36; and (5) satisfactory treatment, determined by patient self-evaluation. Discussion We will discuss whether Shi’s cervical manipulation has greater advantages in efficacy, safety, and satisfaction of acute and subacute neck pain than traditional NSAIDs, to provide a scientific basis for the dissemination and application of Shi’s cervical manipulation. Trial registration China Registered Clinical Trial Registration Center ChiCTR1900021371. Registered on 17 February 2019

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