RecruitingNot Applicable

Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study

China100 participantsStarted 2025-06-01

Plain-language 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-flow nasal cannula (HFNC) flow settings, and to evaluate its application in patients with acute respiratory failure. Primary Research Questions To characterize the features of the DPSI in healthy individuals and in patients with acute respiratory failure. To assess the behavior of the DPSI under different HFNC flow settings in patients with acute respiratory failure. Secondary Research Questions Feasibility and inter-operator reproducibility of diaphragmatic speckle tracking. Assessment of the Diaphragmatic Contraction Synchrony Index. Evaluation of End-Diaphragmatic Residual Contraction (EDRC). Additional fundamental parameters, including diaphragmatic displacement velocity and maximum displacement.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Diaphragmatic Physiology Similarity Index (DPSI)

Timeframe: Healthy Participants: Baseline； Baseline evaluation at the time of enrollment change with each change in ventilation parameters.

Trial details

NCT IDNCT06996665

SponsorSir Run Run Shaw Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

Contact for this trial

Huiqing Ge

+86 13588706787 gehq@zju.edu.cn

View on ClinicalTrials.gov More Respiratory Failure trials