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A Prospective Randomized Controlled Study on the Effects of Diaphragmatic Electrical Stimulation at Different Respiratory Phases on Diaphragmatic Function

A Prospective Randomized Controlled Study on the Effects of Diaphragmatic Electrical Stimulation at Different Respiratory Phases on Diaphragmatic Function

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113041
Enrollment
Unknown
Registered
2025-11-24
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

heart failure

Interventions

Respiration-Synchronized Stimulation Group:A diaphragmatic electrical stimulation protocol that delivers stimulation during the inspiratory phase, synchronized with the patients spontaneous breathing
Fixed-Frequency Stimulation Group:A method of diaphragmatic electrical stimulation that paces the phrenic nerve at a preset frequency.

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Hospitalized due to heart failure; 2. Dyspnea with a Borg scale score = 3 points; 3. Diaphragmatic excursion < 2 cm as measured by ultrasonography; 4. New York Heart Association (NYHA) functional class II-IV; 5. Age between 18 and 80 years; 6. Provided informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients scheduled for emergency surgery based on clinical evaluation (e.g., infective endocarditis, acute coronary syndrome, cardiac tamponade, etc.); 2. Use of intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), continuous renal replacement therapy (CRRT), or left ventricular assist device (LVAD) at admission; 3. Pregnant patients; 4. Body Mass Index (BMI) > 30; 5. Use of a cardiac pacemaker or implantable cardioverter-defibrillator (ICD); 6. Presence of open wounds in the thoracic area or thoracic deformities; 7. Poor diaphragmatic acoustic window, precluding adequate diaphragmatic assessment; 8. Patients receiving invasive mechanical ventilation; 9. Current use of sedative or analgesic medications (e.g., Sufentanil); 10. Patient declined to participate in the study.

Design outcomes

Primary

MeasureTime frame
thickness of diaphragm;

Secondary

MeasureTime frame
diaphragm movement;

Countries

China

Contacts

Public ContactYiyao Shi

Fuwai Hospital, Chinese Academy of Medical Sciences

shiyiyaosherry@163.com+86 155 4021 8858

Outcome results

None listed

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