Non-invasive Phrenic Nerve Stimulation in ARDS Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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ARDS, Human Ventilator-Induced Lung Injury Diaphragm Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PNS group

Electrical stimulation of the phrenic nerve in ARDS patients.

Group Type EXPERIMENTAL

PNS group

Intervention Type DEVICE

non-invasive phrenic nerve stimulation

Interventions

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PNS group

non-invasive phrenic nerve stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult ARDS patients undergoing controlled mechanical ventilation
2. The duration of endotracheal intubation \< 48 hrs

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No