Intraoperative Diaphragmatic Neuromodulation

Launched by BEIJING SANBO BRAIN HOSPITAL · Jul 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new technique called intraoperative phrenic nerve stimulation, which involves stimulating a nerve that controls the diaphragm (the muscle that helps you breathe) during brain surgery. Researchers are interested in seeing if this technique can help reduce complications after surgery, particularly issues like brain injury, delirium (confusion and disorientation), and problems with breathing. The goal is to determine if this method can improve recovery for patients undergoing surgery for brain tumors.

To participate in this trial, individuals need to be at least 18 years old, have a body mass index (BMI) of 30 or less, and qualify for elective brain surgery. They should also be able to breathe with the help of a machine (mechanical ventilation) for at least four hours during the operation. However, people with certain respiratory conditions, recent respiratory infections, or specific neurological disorders are not eligible. Participants will need to sign a consent form, and throughout the study, they will receive careful monitoring to track their recovery and any potential complications. This trial is currently recruiting participants of all genders aged 18 and older.

Gender

ALL

Eligibility criteria

• 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.