Status:
COMPLETED
Intraoperative Diaphragmatic Neuromodulation
Lead Sponsor:
Beijing Sanbo Brain Hospital
Conditions:
Neurosurgery
Phrenic Nerve Stimulation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
【Background】Postoperative complications, such as delirium and pulmonary complications, commonly occur in patients undergoing craniotomy. In preclinical studies, phrenic nerve stimulation (i.e., diaphr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06518707
Start Date
February 26 2024
End Date
February 1 2025
Last Update
September 4 2025
Active Locations (1)
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1
Beijing Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100090