CompletedNot Applicable

Intraoperative Diaphragmatic Neuromodulation

China120 participantsStarted 2024-02-26

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years old; * Body mass index ≤ 30 kg/㎡; * American Society of Anesthesiologists Classification: I-II level; * Patients who undergo elective supratentorial tumor resection surgery; * Mechanical ventilation during operation ≥ 4h; * Signed informed consent form; Exclusion Criteria: * With known respiratory diseases, such as chronic obstructive pulmonary disease, obstructive sleep apnea, asthma, etc.; * History of respiratory infection within 6 months before surgery; * Received invasive or non-invasive mechanical ventilation within 6 months; * Contraindications to extracorporeal diaphragmatic pacemakers, such as pneumothorax, active pulmonary tuberculosis, and wearing a cardiac pacemaker; * Diagnosis with neuromuscular dysfunction diseases such as Guillain-Barre syndrome, myasthenia gravis, muscle atrophy, etc.; * Pregnant or lactating patients; * Preoperative cognitive impairment, consciousness disorders.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of delirium

Timeframe: Within 3 days after surgery

Trial details

NCT IDNCT06518707

SponsorBeijing Sanbo Brain Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Neurosurgery trials