Intraoperative Diaphragmatic Neuromodulation
NCT Number: NCT06518707
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neurosurgery|Phrenic Nerve Stimulation|Postoperative Delirium
Interventions: OTHER: Phrenic nerve stimulation
Sponsor: Beijing Sanbo Brain Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06-01
Completion Date: 2025-02-01
Locations: Beijing Sanbo Brain Hospital, Capital Medical University, Beijing, Beijing, 100090, China

Summary:
This prospective, single-center, randomized controlled clinical trial aims to investigate the impact of intraoperative phrenic nerve stimulation (i.e., diaphragmatic neuromodulation) on postoperative complications in neurosurgical patients. The primary objective is to assess the effect on postoperative brain injury, including the development of delirium and changes in biomarkers. Additionally, the incidence of postoperative pulmonary complications will be investigated.

Primary Outcome Measures: Incidence of delirium, The incidence of delirium is documented using validated delirium scores, determined by either a positive result from the 3-minute diagnostic interview for the Confusion Assessment Method (3D-CAM) scoring sheet, the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), or both, Within 3 days after surgery
Secondary Outcome Measures: Postoperative pulmonary complications, Postoperative pulmonary complications may include respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, acute respiratory distress syndrome, aspiration pneumonia, pulmonary embolism, pulmonary edema, and aggravation of existing lung diseases., Within 7 days after surgery|Post operative diaphragm dysfunction, The patient is placed in a supine position, with a high-frequency linear array probe positioned between the right axillary midline and the 8th to 10th ribs. The probe is rotated to align parallel to the intercostal space. When two parallel high-echo lines appear, the diaphragm is identified between them. The sampling line is placed in the diaphragm movement area, and once the image stabilizes, it is converted to an M-mode ultrasound. The thickness of the inspiratory and expiratory diaphragmatic muscles is measured separately, and the maximum value is obtained by repeating the measurements three times. Diaphragm dysfunction is defined as a fraction of diaphragm thickening less than 20%., Before the surgery and within 24 hours and 48 hours after surgery.|Length of stay in Intensive Care Unit (ICU), The time between the patient's admission to the ICU and the patient's discharge from the ICU is referred to as the length of stay in the ICU., The time from ICU admission to transfer to the ward or death, whichever occurred first, was assessed for up to 180 days.|Length of hospital stay, The time between the patient's admission to the hospital and the patient's discharge from the hospital is referred to as the length of stay in the hospital., The period from hospital admission to discharge or death, whichever occurred first, was assessed for up to 180 days.|White blood cell, Collect preoperative and postoperative blood routine and biochemical information from patients, specifically focusing on white blood cell counts before and after surgery., Before the surgery and within 24 hours and 48 hours after surgery.|S100 calcium-binding protein B (S-100B), Evaluation of serum S-100B protein levels in patients at baseline, immediate postoperative state, and 48 hours after surgery., Before the surgery and within 24 hours and 48 hours after surgery.|Glial Fibrillary acidic protein (GFAP), Evaluation of serum GFAP levels in patients at baseline, immediate postoperative state, and 48 hours after surgery., Before the surgery and within 24 hours and 48 hours after surgery.|Brain-derived neurotrophic factor (BDNF), Evaluation of serum BDNF levels in patients at baseline, immediate postoperative state, and 48 hours after surgery., Before the surgery and within 24 hours and 48 hours after surgery.|Neuron-specific enolase (NSE), Evaluation of serum NSE levels in patients at baseline, immediate postoperative state, and 48 hours after surgery., Before the surgery and within 24 hours and 48 hours after surgery.