Efficacy of transcutaneous electrical acupoint stimulation for the treatment of gastrointestinal dysfunction in patients after cardiac surgery with cardiopulmonary bypass: study protocol for a superiority, single-centre, single-blind, randomised controlled clinical trial

经皮穴位电刺激治疗体外循环心脏手术后患者胃肠功能障碍的疗效:一项优效性、单中心、单盲、随机对照临床试验的研究方案

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Abstract

OBJECTIVE: Gastrointestinal dysfunction is one of the most frequent complications in patients after cardiac surgery with cardiopulmonary bypass (CPB). It can seriously affect the patient's quality of life, increase the length of hospitalisation and in severe cases trigger cardiac arrest. This single-centre randomised controlled study aims to investigate whether transcutaneous electrical acupoint stimulation (TEAS) can effectively relieve gastrointestinal discomfort and improve the quality of life of patients after cardiac surgery. METHODS AND ANALYSIS: A total of 426 patients after cardiac surgery with CPB will be randomly assigned to the control group or intervention group (1:1 ratio) to receive either acupressure or TEAS for 3 days. The patients will be recruited from the Department of Cardiovascular Surgery of Nanfang Hospital. The primary outcome is the time of the first postoperative anal defecation, the secondary outcomes include the first postoperative anal exsufflation time, the number of bowel sounds, the proportion of postoperative laxatives used in the two groups, abdominal girth, stool frequency per day and length of postoperative hospital stay. ETHICS AND DISSEMINATION: The procedures have been approved by the Guangdong Regional Medical Ethics Committee of Nanfang Hospital (NFEC-2023-404) and conformed to the Declaration of Helsinki. Written informed consent will be obtained from all the participants. Results will be disseminated through workshops, peer-reviewed publications and conferences. TRIAL REGISTRATION: Registered in Chinese Trial Registry (https://www.chictr.org.cn/) on 1 November 2023 (Registered number: ChiCTR2300077211). Pre-result.

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