Status:
RECRUITING
Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study
Lead Sponsor:
Sir Run Run Shaw Hospital
Conditions:
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study Objective This prospective observational study aims to investigate the role of the Diaphragmatic Physiology Similarity Index (DPSI) derived from speckle tracking ultrasound in titrating high-flo...
Eligibility Criteria
Inclusion
- Feasibility and reproducibility：adult ICU patients
- Methodology for diaphragmatic motion synchrony:healthy adults and adult ICU patients Between-group comparisons and flow-titration study
- Age ≥18 years old.
- Clear diagnosis of respiratory failure requiring respiratory support.
- Expected duration of respiratory support ≥24 hours or (high-flow/non-invasive ventilation) ≥48 hours.
- Voluntary participation in this study and signed informed consent. If the participant is unable to read or sign the informed consent form due to incapacity (e.g., unconsciousness), the legal guardian must act as a proxy in the informed consent process and sign the form. If the participant cannot read the consent form (e.g., illiterate participants), a witness must observe the informed consent process and sign the form.
Exclusion
- Severe chest wall deformities or diaphragmatic paralysis.
- End-stage disease with a predicted life expectancy of less than 24 hours.
- Inability to acquire STE (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations).
- Vulnerable groups other than critically ill patients/elderly/illiterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 2 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06996665
Start Date
June 1 2025
End Date
December 2 2026
Last Update
December 3 2025
Active Locations (2)
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1
Sir Run Run shaw Hospital Zhejiang University
Hangzhou, Zhejiang, China, 310000
2
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China