Non-invasive Phrenic Nerve Stimulation in ARDS Patient

NCT06572280 | Recruiting

• 1 other identifier: NPES-diaphragm protection
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ARDS, Human; Ventilator-Induced Lung Injury; Diaphragm Injury

Keywords

ARDS; diaphragm injury; mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• Frequency of enough Tidal volume

  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

  Procedure (from enrollment to extubation)

• The speed of successful non-invasive electrical stimulation deployment

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

  Procedure (from enrollment to extubation)

Secondary Outcomes (6)

• Driving pressure

  Procedure (from enrollment to extubation)

• Diaphragm thickening fraction

  up to 28 days

• Diaphragm excursion

  up to 28 days

• Maximal inspiratory pressure (MIP)

  Procedure (from enrollment to extubation)

• ventilation distribution

  Procedure (from enrollment to extubation)

Study Arms (1)

PNS group

EXPERIMENTAL

Electrical stimulation of the phrenic nerve in ARDS patients.

Device: PNS group

Interventions

PNS group DEVICE

non-invasive phrenic nerve stimulation

PNS group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• ling liu, phD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ling liu, phD

CONTACT

15901599659; 18826401594@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 27, 2024
• Study Start: August 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)