Non-invasive Phrenic Nerve Stimulation in ARDS Patient

Not Applicable

Recruiting

• Conditions: Diaphragm Injury; Ventilator-Induced Lung Injury; ARDS, Human
• Interventions: Device: PNS group

• Registration Number: NCT06572280
• Lead Sponsor: Southeast University, China

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.

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 Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-25
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PNS group	PNS group	Electrical stimulation of the phrenic nerve in ARDS patients.

Primary Outcome Measures

Name	Time	Method
The speed of successful non-invasive electrical stimulation deployment	Procedure (from enrollment to extubation)	Time between first successful electrical phrenic stimulation and identification of the optimal stimulation locus in seconds
Frequency of enough Tidal volume	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

Secondary Outcome Measures

Name	Time	Method
Diaphragm thickening fraction	up to 28 days	Diaphragm thickening fraction measured with ultrasound of the diaphragm.
Driving pressure	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
Diaphragm excursion	up to 28 days	Diaphragm excursion measured with ultrasound of the diaphragm.
Respiratory system compliance	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.
ventilation distribution	Procedure (from enrollment to extubation)	ventilation distribution was measured by EIT
Maximal inspiratory pressure (MIP)	Procedure (from enrollment to extubation)	MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.

Trial Locations

Locations (1)

Zhongda Hospital, School of Medicine, Southeast University; 🇨🇳 Nanjing, Jiangsu, China