ARDS, Human, Diaphragm Injury, Ventilator-Induced Lung Injury
Conditions
Keywords
ARDS, diaphragm injury, mechanical ventilation
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.
Interventions
DEVICEPNS group
non-invasive phrenic nerve stimulation
Sponsors
Southeast University, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragm thickening fraction | up to 28 days | Diaphragm thickening fraction measured with ultrasound of the diaphragm. |
| Maximal inspiratory pressure (MIP) | Procedure (from enrollment to extubation) | MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation. |
| 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 |
| 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 |
Countries
China
Contacts
Primary Contactling liu, phD
Outcome results
None listed