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Brain surgery breakthrough? diaphragm zap may cut delirium risk

NCT ID NCT06518707

Disease control Sponsor: Beijing Sanbo Brain Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether using a device to stimulate the diaphragm (the main breathing muscle) during brain surgery could lower the risk of postoperative problems like confusion (delirium) and lung issues. Researchers enrolled 120 adults undergoing brain tumor removal. Half received the stimulation during surgery, while the other half did not. The goal was to see if this simple intervention could improve recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
phrenic nerve stimulation (diaphragm pacing)
What this could lead to
If it works, this could point toward a simple way to protect the brain and lungs during neurosurgery, reducing recovery problems.
What could go wrong
This is a small, single-center study with no blinding, so results may not apply widely. The intervention is experimental and may not reduce complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Feb 2024

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Emergence Delirium supratentorial cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurosurgery Phrenic nerve stimulation Postoperative delirium

Contacts and locations

Locations

  • Beijing Sanbo Brain Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100090, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.