NeurosurgeryNCT06518707

Intraoperative Diaphragmatic Neuromodulation

A study testing Phrenic nerve stimulation in people with Neurosurgery and Phrenic Nerve Stimulation, run by Beijing Sanbo Brain Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neurosurgery, Phrenic Nerve Stimulation, Postoperative Delirium
What is being tested?: Phrenic nerve stimulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 26 Feb 2024to 1 Feb 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, 100090

Other trials in China

About this study

Official title: Impact of Intraoperative Diaphragmatic Neuromodulation on Postoperative Complications in Neurosurgical Patients: A Prospective, Randomized Controlled Study

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.

Read the 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., diaphragmatic neuromodulation) has been reported to effectively mitigate brain injury and pulmonary complications. However, its intraoperative administration and its impact on postoperative complications in this population are largely unknown.

【Method】In this prospective, single-center, randomized controlled clinical trial, patients receiving elective craniotomy will be screened. Eligible patients will be randomly divided into three groups: 1) Control group (without any interventions); 2) Intraoperative phrenic nerve stimulation (PNS) without total neuromuscular blockade (Train-of-Four (TOF) = 0); 3) Intraoperative PNS with partial neuromuscular blockade (TOF in the range of 1-2). Diaphragm ultrasound will be performed to assess diaphragm function before surgery and at 24 hours and 48 hours after surgery, respectively. Postoperative delirium will be assessed daily using the 3D-CAM and CAM-ICU within 3 days. Plasma biomarkers of brain injury will also be tested at baseline, 24 hours, and 48 hours after surgery. Pulmonary complications will be diagnosed by three independent clinicians based on laboratory tests, imaging, and clinical signs.

【Aims and Hypothesis】The primary aims are to investigate the impact of intraoperative diaphragmatic neuromodulation on brain injury, including the occurrence of delirium and changes in biomarkers. The secondary aims are the incidence of postoperative pulmonary complications and other clinical outcomes. We hypothesize that intraoperative diaphragmatic neuromodulation could reduce brain injury induced by craniotomy, as well as the incidence of postoperative delirium and pulmonary complications.

Conditions: Neurosurgery, Phrenic Nerve Stimulation, Postoperative Delirium
Being tested: Phrenic nerve stimulation
Keywords: Phrenic nerve stimulation, Postoperative delirium, Postoperative pulmonary complications
Medical subject headings: Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phrenic nerve stimulationOther
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.

Study groups in NCT06518707
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Phrenic nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Within 3 days after surgery

Secondary outcomes (9)

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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before the surgery and within 24 hours and 48 hours after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 20241 Feb 2025

First posted24 Jul 2024
Study start26 Feb 2024
Primary completion30 Dec 2024
Study completion1 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NeurosurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06518707
Sponsor's protocol ID: Dia-the-Brain
Status last verified: Aug 2025
First submitted: 18 Jun 2024
Last updated: 4 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Intraoperative Diaphragmatic Neuromodulation on Postoperative Complications in Neurosurgical Patients: A Prospective, Randomized Controlled Study
ClinicalTrials.gov ID: NCT06518707
Acronym / sponsor ID: Dia-the-Brain
Conditions: Neurosurgery, Phrenic Nerve Stimulation, Postoperative Delirium
Keywords: Phrenic nerve stimulation, Postoperative delirium, Postoperative pulmonary complications
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Beijing Sanbo Brain HospitalUniversity, hospital or other
Study start: 26 Feb 2024 (actual)
Primary completion: 30 Dec 2024 (actual)
Study completion: 1 Feb 2025 (actual)
First posted: 24 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
Control group	No intervention	–No intervention will be performed; all protocols during surgery will follow the clinical routine.
PNS + TOF 0	Experimental	Other: Phrenic nerve stimulationPatients 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.
PNS + TOF 1-2	Experimental	Other: Phrenic nerve stimulationPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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.;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Phrenic nerve stimulationA 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.	Other	PNS + TOF 0, PNS + TOF 1-2

Primary outcome

Incidence of delirium
Time frame: Within 3 days after surgery
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

9 secondary outcomes

Postoperative pulmonary complications
Time frame: Within 7 days after surgery
Post operative diaphragm dysfunction
Time frame: Before the surgery and within 24 hours and 48 hours after surgery.
Length of stay in Intensive Care Unit (ICU)
Time frame: 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
Time frame: The period from hospital admission to discharge or death, whichever occurred first, was assessed for up to 180 days.
White blood cell
Time frame: Before the surgery and within 24 hours and 48 hours after surgery.
S100 calcium-binding protein B (S-100B)
Time frame: Before the surgery and within 24 hours and 48 hours after surgery.
Glial Fibrillary acidic protein (GFAP)
Time frame: Before the surgery and within 24 hours and 48 hours after surgery.
Brain-derived neurotrophic factor (BDNF)
Time frame: Before the surgery and within 24 hours and 48 hours after surgery.
Neuron-specific enolase (NSE)
Time frame: Before the surgery and within 24 hours and 48 hours after surgery.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Neurosurgery

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Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
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Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
Enrolling by invitationObservational study
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Patients Operated on at the Neurosurgery Department
Enrolling by invitation
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhonghua Shi, PhD, MD principal investigator

Beijing Sanbo Brain Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Phrenic nerve stimulation in people with Neurosurgery and Phrenic Nerve Stimulation, run by Beijing Sanbo Brain Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of delirium (time frame: Within 3 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06518707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.