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Effects of phrenic nerve electrical stimulation on diaphragm function and weaning outcomes

External phrenic nerve pacing to preserve diaphragm function and improve weaning outcomes: a feasibility study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17616237
Enrollment
60
Registered
2021-07-02
Start date
2020-07-01
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute respiratory failure requiring invasive mechanical ventilation Respiratory Acute respiratory failure

Interventions

After the candidates or their family members sign the informed consent, the research staff contacts the liaison of the lead center for central randomization by specially assigned staff.
painful movements of the body may be slow, cautious movement, touching the pain, and seeking attention through movement. For patients with internal jugular vein catheterization, if the

Sponsors

Sir Run Run Shaw Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with acute respiratory failure requiring invasive mechanical ventilation *Incorporated within 48 hours after the establishment of the artificial airway 2. Estimated mechanical ventilation time >72 hours 3. Aged over 18 years old

Exclusion criteria

Exclusion criteria: 1. Pneumothorax or mediastinal emphysema 2. Acute myocarditis, severe arrhythmia 3. Neuromuscular diseases that may affect weaning, including myasthenia gravis, motor neuron disease, and congenital myopathy 4. Hemodynamic instability (mean arterial pressure 0.2 ug/kg/min) 5. Paroxysmal sympathetic hyperactivity syndrome 6. Even chest 7. Pregnancy 8. Fitted with a pacemaker/implantable defibrillator 9. Applying neuromuscular blockers (NMBAs) within the past 6 hours 10. History of neck radiation therapy or neck surgery 11. Cancer of the neck and lung 12. Unable to obtain accurate diaphragm ultrasound results

Design outcomes

Primary

MeasureTime frame
1. Enrollment rate: number of enrolled patients divided by total number of patients meeting the criteria of this study at 48 hours after the establishment of an artificial airway 2.Retention rate (incorporating acceptability of the therapy): number of patients who completed the study divided by number of patients admitted at the end of the entire experiment 3. Response rate: diaphragmatic mobility measured by ultrasound at the first EDP treatment 4. Incidence rate of adverse events measured using number of patients with adverse events divided by patients enrolled in the group during the entire test

Secondary

MeasureTime frame
1. Diaphragm thickness: at the end of exhalation and inspiration the thickness of the right diaphragm will be measured using diaphragm ultrasound during tidal breathing to calculate the muscle thickening score. Measured at baseline, every other day, for the first SBT (under EDP) and on day 28 2. Diaphragm mobility: right diaphragmatic mobility, inspiratory time, inspiratory slope and acceleration measured using diaphragm ultrasound at the first SBT (under EDP treatment) 3. Duration of mechanical ventilation, reintubation, weaning success rate and survival rate measured using patient records within 28 days 4. Blood gas analysis using blood gas analysis instrument before and after EDP session every morning

Countries

China

Contacts

Public ContactYuejia Ding
ding_yuejia@zju.edu.cn+86 (0)18268113280

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026