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Effect of extracorporeal diaphragmatic pacemaker combined with postural management on the success rate of mechanical ventilation withdrawal in patients with severe stroke

Effect of extracorporeal diaphragmatic pacemaker combined with postural management on the success rate of mechanical ventilation withdrawal in patients with severe stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120576
Enrollment
Unknown
Registered
2026-03-17
Start date
2026-03-30
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Stroke

Interventions

Experimental group:Routine intervention + external diaphragm pacemaker + position management
control group:Routine intervention + postural management

Sponsors

The First Affiliated Hospital of Jishou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for severe stroke in the 2025 "Chinese Guidelines for the Management of Severe Stroke" 2. Age 20-70 years old 3. Diagnosis of first acute ischemic or hemorrhagic stroke by CT or MRI (onset time = 48 hours, and met the screening criteria of autonomous breathing test (conscious, stable hemodynamics, oxygenation index >= 150mmHg, etc.) 5. Difficulty in withdrawing from the machine with clinical judgment (failure of the first autonomous breathing test or expected difficulty)

Exclusion criteria

Exclusion criteria: 1. History of diaphragmatic paralysis or severe spinal cord injury 2. Severe hemodynamic instability (requiring a large amount of vasoactive drugs to maintain) 3. Severe abdominal distension, intra-abdominal hypertension, or recent abdominal surgery. 4. Severe chest deformities and multiple rib fractures with flail chest or skin diseases, unable to tolerate PM. 5. implantation of pacemakers or other electrical stimulation devices. 6. Neck and chest skin damage/burns/infections, unable to stick electrodes. 7. Expected survival = 2), bronchitis). 9. The patient or legal representative refuses to be randomized or is unable to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Weaning Success Rate;diaphragm thickness;

Secondary

MeasureTime frame
diaphragmatic thickening;bedside heart rate variability;Incidence of respirator-associated pneumonia (VAP);Total mechanical ventilation time;arterial partial pressure of oxygen;arterial carbon dioxide partial pressure;28-Day mortality rate;

Countries

China

Contacts

Public ContactShunyong Peng

The First Affiliated Hospital of Jishou University

406062913@qq.com+86 183 9097 7998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026