研究疾病:
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呼吸机相关性膈肌功能障碍
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研究疾病代码:
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Target disease:
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Ventilator-Associated Diaphragmatic Dysfunction
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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通过超声观察膈肌厚度变异率、膈肌呼吸动度,证实电针对膈肌功能的影响;
通过呼吸机不同模式进行分层,观察不同呼吸机模式对膈肌功能影响;
通过比较动脉血气分析、呼吸机模式及参数、脱机时间,证实电针通过兴奋膈肌,间接改善患者呼吸功能,甚至提高脱机成功率;
通过28天病亡率、住院费用时间等证实电针对患者最终指标及对社会效益的影响;
通过观测丙二醛(MDA)和超氧化物歧化酶(SOD),从自噬通路的氧化应激反应,寻找电针治疗VIDD的作用靶点;
通过观测肿瘤坏死因子-α、IL-1β、IL-2R、IL-6、IL-8、IL-10等炎性因子,论证焦亡通路存在的可能,为今后机制实验打下基础,并寻找电针作用靶点。
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Objectives of Study:
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The effect of electroacupuncture on diaphragm function was confirmed by observing the variation rate of diaphragm thickness and diaphragmatic respiratory movement by ultrasound.
Stratification by different ventilator modes to observe the effect of different ventilator modes on diaphragm function;
By comparing arterial blood gas analysis, ventilator mode and parameters, and weaning time, it is confirmed that electroacupuncture indirectly improves the patient's respiratory function by stimulating the diaphragm, and even increases the success rate of weaning;
Confirm the final indicators of electroacupuncture patients and the impact on social benefits through 28-day mortality rate, hospitalization time, etc.;
By observing malondialdehyde (MDA) and superoxide dismutase (SOD), from the oxidative stress response of autophagy pathway, to find the target of electroacupuncture in the treatment of VIDD;
By observing inflammatory factors such as tumor necrosis factor-α, IL-1β, IL-2R, IL-6, IL-8, IL-10, etc., the possibility of the existence of the pyroptosis pathway is demonstrated, which lays the foundation for future mechanism experiments and searches for electrical pathways. Needle target.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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同时符合以下全部条件者方可纳入:①自愿参加,理解并签署知情同意书;②有创呼吸机治疗符合上述诊断标准;③年龄18-90岁;性别不限;④无针刺、电针禁忌症。
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Inclusion criteria
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Only those who meet all of the following conditions can be included: ① Voluntary participation, understanding and signing the informed consent form; ② Invasive ventilator treatment meets the above diagnostic criteria; ③ Age 18-90 years old; gender is not limited; ④ No acupuncture or electroacupuncture Contraindications.
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排除标准:
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符合下述任一条件者,应予以排除:①影响超声测定的因素:胸腔引流、腹部感染、腹腔高压、近一个月内腹部手术、年龄>90岁或<18岁、妊娠、24h内使用过神经肌肉阻滞剂、镇静剂、已知的膈肌畸形或损伤;②严重代谢异常、已知的神经肌肉病变和呼吸中枢病变;③安装心脏起搏器;④选穴局部存在皮损、肿瘤等病变;⑤在7日干预阶段内,出现疾病急性加重:感染急性加重出现脓毒症、凝血功能障碍、多脏器功能衰竭;⑥由于各种原因出现急性脏器功能障碍:肝衰竭:转氨酶1日内上高100IU/L以上,或连续3日升高250IU/L以上;肾衰竭:肌酐1日内上升70umol/L以上,或连续3日升高170umol/L以上;心衰:BNP1日内上升1500pg/ml以上,或连续3日升高3000pg/ml以上;肺栓塞:新发肺栓塞明确诊断的;急性胰腺炎:新发急性胰腺炎明确诊断的;其他新发的严重影响预后的急性病(如脑梗、脑出血、心梗等)。
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Exclusion criteria:
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Those who meet any of the following conditions should be excluded: ① Factors affecting ultrasound determination: thoracic drainage, abdominal infection, abdominal hypertension, abdominal surgery within the past month, age > 90 or < 18, pregnancy, use within 24 hours Neuromuscular blockers, sedatives, known diaphragmatic deformity or injury; ②Severe metabolic abnormalities, known neuromuscular disease and respiratory center disease; ③Installation of cardiac pacemaker; ④Local lesions such as skin lesions, tumors, etc. 5. Within the 7-day intervention period, acute exacerbation of disease: sepsis, coagulation dysfunction, and multiple organ failure due to acute exacerbation of infection; ⑥ Acute organ dysfunction due to various reasons: liver failure: transaminase within 1 day Increased by more than 100IU/L, or by more than 250IU/L for 3 consecutive days; Renal failure: creatinine increased by more than 70umol/L within 1 day, or increased by more than 170umol/L for 3 consecutive days; Heart failure: BNP increased by 1500pg/ml within 1 day above, or increased by 3000pg/ml or more for 3 consecutive days; pulmonary embolism: new pulmonary embolism with a definite diagnosis; acute pancreatitis: new acute pancreatitis with a definite diagnosis; other new acute diseases that seriously affect the prognosis (such as cerebral infarction) , cerebral hemorrhage, myocardial infarction, etc.).
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研究实施时间:
Study execute time:
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从From
2022-08-14
至To
2024-04-01
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征募观察对象时间:
Recruiting time:
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从From
2022-08-14
至To
2024-04-01
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