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The effect of external diaphragmatic pacing with diaphragmatic effort titration combined with respiratory training on the clinical prognosis of patients undergoing assisted mechanical ventilation after brain injury

The effect of external diaphragm pacing with diaphragmatic effort titration combined with respiratory training on the clinical prognosis of patients undergoing assisted mechanical ventilation after brain injury - The effect of external diaphragm pacing with diaphragmatic effort titration combined with respiratory training on the clinical prognosis of patients undergoing assisted mechanical ventilation after brain injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073005
Enrollment
Unknown
Registered
2023-06-29
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

brain injury

Interventions

Test group:External diaphragm pacing based on diaphragmatic effort titration
Control group:External diaphragm pacing based on experience or patient tolerance

Sponsors

China Rehabilitation Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) Age>18 years old; 2) According to head CT or MRI, diagnosed with brain injury, receiving auxiliary ventilation PSV and delayed weaning; 3) Vital signs are stable for more than 24 hours, and low dose of vasoactive drugs (epinephrine 0.01-0.05 ug/kg/min, dopamine hydrochloride 1-5 ug/kg/min, Norepinephrine<0.1 g/kg/min) are not needed or only used; 4) No corticosteroids or muscle relaxants were used.

Exclusion criteria

Exclusion criteria: 1) Successfully taken offline, or mechanical ventilation needs to be controlled; 2) Abnormal Intracranial pressure; 3) Diaphragm overexertion, non-invasive respiratory mechanics index P0.1>4.0cmH2O, ? Pocc>20.0cmH2O; 4) Uncontrolled seizures, paroxysmal sympathetic hyperactivity syndrome; 5) Previous diagnosis of obstructive or restrictive pulmonary disease, unstable cardiovascular disease, severe liver and kidney damage; 6) Complicated with thoracic deformity and new Rib fracture; 7) Implantation of metal foreign bodies into the body; 8) Diaphragmatic hernia; 9) Family members refuse to sign informed consent.

Design outcomes

Primary

MeasureTime frame
success rate of weaning;—

Secondary

MeasureTime frame
ventilation free days in 8 weeks;Total mechanical ventilation time within 8 weeks (days);The incidence of pulmonary infections;Fraction of diaphragm thickening;Diaphragm excursion ;ICU length of stay ;glasgow outcome scale after 6 months;6-month cumulative survival rate;—

Countries

China

Contacts

Public ContactYanying Wang

China Rehabilitation Research Center

yayawo999@126.com+86 131 4604 5906

Outcome results

None listed

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