Non-invasive Phrenic Nerve Stimulation in ARDS Patient

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilator-Induced Lung Injury; ARDS, Human; Diaphragm Injury
• Intervention / Treatment: Device: PNS group

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ling liu, phD; Phone Number: 15901599659; Email: 18826401594@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital, School of Medicine, Southeast University
      • Contact: ling liu, phD; Phone Number: 15901599659; Email: 18826401594@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PNS group; Electrical stimulation of the phrenic nerve in ARDS patients.	Device: PNS group; non-invasive phrenic nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driving pressure	driving pressure was measured in the volume-controlled mode and calculated as the difference between plateau pressure and positive end-expiratory pressure	Procedure (from enrollment to extubation)
Diaphragm thickening fraction	Diaphragm thickening fraction measured with ultrasound of the diaphragm.	up to 28 days
Diaphragm excursion	Diaphragm excursion measured with ultrasound of the diaphragm.	up to 28 days
Maximal inspiratory pressure (MIP)	MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.	Procedure (from enrollment to extubation)
ventilation distribution	ventilation distribution was measured by EIT	Procedure (from enrollment to extubation)
Respiratory system compliance	Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure.	Procedure (from enrollment to extubation)

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: ling liu, phD, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: mechanical ventilation; ARDS; diaphragm injury
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Respiratory Distress Syndrome; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: NPES-diaphragm protection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No