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Recruiting NCT06572280

Non-invasive Phrenic Nerve Stimulation in ARDS Patient

No phase Interventional ARDS, Human Ventilator-Induced Lung Injury Diaphragm Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PNS group.
Who it may be relevant to
Registry conditions: ARDS, Human, Ventilator-Induced Lung Injury, Diaphragm Injury. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study

Overview

Reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury and ventilator-induced diaphragm dysfunction, thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with ARDS undergoing mechanical ventilation remain unclear and require further investigation.

Detailed description

Mechanical ventilation is an important treatment for patients with acute hypoxemic respiratory failure (AHRF). However, reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality in these patients. In patients with AHRF undergoing mechanical ventilation, maintaining moderate spontaneous breathing under lung and diaphragm protective ventilation remains challenging. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD), thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with acute respiratory distress syndrome (ARDS) undergoing mechanical ventilation remain unclear and require further investigation.

Interventions

  • Device PNS group
    non-invasive phrenic nerve stimulation

Primary outcome measures

  • Frequency of enough Tidal volume [Time frame: Procedure (from enrollment to extubation)]
  • The speed of successful non-invasive electrical stimulation deployment [Time frame: Procedure (from enrollment to extubation)]
Secondary outcome measures (6)
  • Driving pressure [Time frame: Procedure (from enrollment to extubation)]
  • Diaphragm thickening fraction [Time frame: up to 28 days]
  • Diaphragm excursion [Time frame: up to 28 days]
  • Maximal inspiratory pressure (MIP) [Time frame: Procedure (from enrollment to extubation)]
  • ventilation distribution [Time frame: Procedure (from enrollment to extubation)]
  • Respiratory system compliance [Time frame: Procedure (from enrollment to extubation)]

Eligibility criteria

Inclusion criteria

  • Adult ARDS patients undergoing controlled mechanical ventilation
  • The duration of endotracheal intubation < 48 hrs

Exclusion criteria

  • Neurological condition affecting motor neuron or muscle (e.g. ALS)
  • Paralysis of the phrenic nerve
  • Proven or suspected spinal cord injury
  • Conditions that limit diaphragm movement
  • Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
  • Patients with implanted medical pumps
  • Pregnancy
  • Patients with skin lesions, infections or strictures in throat/neck area
  • Patients with metallic implants
  • Refusal to sign informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Zhongda Hospital, School of Medicine, Southeast University — Nanjing

Identifiers

NCT: NCT06572280 · NPES-diaphragm protection

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗