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NCT Number: NCT06572280

Non-invasive Phrenic Nerve Stimulation in ARDS Patient

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

ling liu, phD

CONTACT

[email protected]

15901599659

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PNS group

Device

non-invasive phrenic nerve stimulation

Primary outcomes

  1. Frequency of enough Tidal volume

    Time frame: Procedure (from enrollment to extubation)

    Percentage of stimulated breaths above the cut-off target tidal volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths

  2. The speed of successful non-invasive electrical stimulation deployment

    Time frame: Procedure (from enrollment to extubation)

    Time between first successful electrical phrenic stimulation and identification of the optimal stimulation locus in seconds

Secondary outcomes

  1. Driving pressure

    Time frame: Procedure (from enrollment to extubation)

    driving pressure was measured in the volume-controlled mode and calculated as the difference between plateau pressure and positive end-expiratory pressure

  2. Diaphragm thickening fraction

    Time frame: up to 28 days

    Diaphragm thickening fraction measured with ultrasound of the diaphragm.

  3. Diaphragm excursion

    Time frame: up to 28 days

    Diaphragm excursion measured with ultrasound of the diaphragm.

  4. Maximal inspiratory pressure (MIP)

    Time frame: Procedure (from enrollment to extubation)

    MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.

  5. ventilation distribution

    Time frame: Procedure (from enrollment to extubation)

    ventilation distribution was measured by EIT

  6. Respiratory system compliance

    Time frame: Procedure (from enrollment to extubation)

    Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure.

Study contacts

Contact information is provided by the study sponsor or research team.

ling liu, phD

CONTACT

[email protected]

15901599659

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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