Intraoperative Diaphragmatic Neuromodulation

NCT06518707 | Completed

• 1 other identifier: Dia-the-Brain
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neurosurgery; Phrenic Nerve Stimulation; Postoperative Delirium

Keywords

Phrenic nerve stimulation; Postoperative delirium; Postoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Postoperative pulmonary complications

  Within 7 days after surgery

• Post operative diaphragm dysfunction

  Before the surgery and within 24 hours and 48 hours after surgery.

• Length of stay in Intensive Care Unit (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 period from hospital admission to discharge or death, whichever occurred first, was assessed for up to 180 days.

• White blood cell

  Before the surgery and within 24 hours and 48 hours after surgery.

Study Arms (3)

Control group

NO INTERVENTION

No intervention will be performed; all protocols during surgery will follow the clinical routine.

PNS + TOF 0

EXPERIMENTAL

Patients in this group will receive PNS during surgery, with the train-of-four (TOF) maintained at a level of 0. Additionally, to ensure complete blockade of the neuromuscular system, the Post-Tetanic Count (PTC) will be monitored and maintained at less than or equal to 3 simultaneously.

Other: Phrenic nerve stimulation

PNS + TOF 1-2

EXPERIMENTAL

Patients in this group will receive PNS during surgery, and the TOF will be maintained at levels 1-2. In this group, the neuromuscular junction will not be fully blocked.

Other: Phrenic nerve stimulation

Interventions

Phrenic nerve stimulation OTHER

A commercial phrenic nerve stimulation equipment will be used during surgery. Phrenic nerve stimulation intensity will be determined before surgery, ensuring significant diaphragm contraction under stimulation. The use of an electric knife will be avoided during surgery. Tidal volume, airway pressure, and vital signs will be monitored continuously.

PNS + TOF 0; PNS + TOF 1-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (1)

Beijing Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing Municipality, 100090, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Zhonghua Shi, PhD, MD

  Beijing Sanbo Brain Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: During the study period, the investigator will set the intensity of the phrenic nerve stimulation, so the investigator will not be masked. However, patients who are enrolled in this study and assessors who assess the clinical outcomes will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy president of the department ICU

Model Details: The intervention groups include two groups: each group will receive phrenic nerve stimulation under different degrees of neuromuscular blockade, i.e., the TOF 0 group and the TOF 1-2 group.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 24, 2024
• Study Start: February 26, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)