Clinical trial NCT06572280: Non-invasive Phrenic Nerve Stimulation in ARDS Patient
Official title: Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ARDS, Human
Ventilator-Induced Lung Injury
Diaphragm Injury
Keywords: ARDS
diaphragm injury
mechanical ventilation
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of enough Tidal volume
timeFrame: Procedure (from enrollment to extubation)
measure: The speed of successful non-invasive electrical stimulation deployment
timeFrame: Procedure (from enrollment to extubation)
Secondary outcomes:
measure: Driving pressure
timeFrame: Procedure (from enrollment to extubation)
measure: Diaphragm thickening fraction
timeFrame: up to 28 days
measure: Diaphragm excursion
timeFrame: up to 28 days
measure: Maximal inspiratory pressure (MIP)
timeFrame: Procedure (from enrollment to extubation)
measure: ventilation distribution
timeFrame: Procedure (from enrollment to extubation)
measure: Respiratory system compliance
timeFrame: Procedure (from enrollment to extubation)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, School of Medicine, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: ling liu, phD
role: PRINCIPAL_INVESTIGATOR
References: