Effectiveness of neuromuscular electrical stimulation in severe acute pancreatitis complicated patients with acute respiratory distress syndrome: study protocol for a randomized controlled trial

BACKGROUND: Severe acute pancreatitis complicated by acute respiratory distress is a common cause of intensive care unit (ICU) admission. These patients are at risk of a decline in physical activity due to bed rest. Neuromuscular electrical stimulation (NMES) has been recommended for ICU patients to strengthen muscles, but its effects on muscle atrophy, respiratory function, multiple organ dysfunction, and functional status of these patients remain to be proven. METHODS: Patients (n = 80) will be prospectively randomized into an NMES group and a control group. The NMES group will receive NMES for 1 h per day for 7 days, and both the control and NMES groups will receive usual care. The efficacy will be assessed by an experienced physiotherapist and sonographer who will be blinded to the patient’s group assignment. Muscle power assessment (MRC scale), lower extremity circumference, grip strength, activities of daily living (Barthel index), and Marshall scores will be measured at baseline and posttreatment. The functions of the diaphragm assessments will be measured daily. Barthel index measurements will be followed up in the 1st month, 3rd month, and 6th month after discharge. DISCUSSION: The trial will explore the effectiveness of NMES in functional status and diaphragm function in patients with SAP complicated with ARDS. The results of this trial will provide strong evidence of the efficacy of NMES in treating SAP patients with ARDS. TRIAL REGISTRATION: This trial has been registered at the Chinese Clinical Trial Registry, and the registry name is “Effectiveness of neuromuscular electrical stimulation in severe acute pancreatitis complicated patients with acute respiratory distress syndrome: study protocol for a randomized controlled trial,” URL: https://www.chictr.org.cn, numbered ChiCTR2300068995. Date of Registration: 2023-03-03. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07642-0.