Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using a diaphragm ultrasound index (DPSI) to set high-flow nasal oxygen flow

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

Run by Sir Run Run Shaw Hospital · NCT06996665 · Data updated 2026-11-12

This will test whether a diaphragm ultrasound score (DPSI) can help doctors set the best high-flow nasal cannula (HFNC) flow for adults with acute respiratory failure.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorSir Run Run Shaw Hospital
Academic / other
Locations2 sites (Hangzhou, Zhejiang and 1 other locations)
StatusRecruiting
StartedJune 1, 2025
Main results expectedDecember 30, 2025
Study endsDecember 2, 2026
Registry record updatedMarch 25, 2026
Trial IDNCT06996665 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (≥18 years) with a clear diagnosis of acute respiratory failure who require respiratory support (HFNC or noninvasive ventilation) and are expected to need support for at least 24–48 hours.

Probably not a fit

Patients with severe chest wall deformities, diaphragmatic paralysis, very limited life expectancy (<24 hours), or those unable to obtain adequate diaphragm ultrasound windows are unlikely to benefit from DPSI-guided titration.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study using speckle-tracking ultrasound to derive a Diaphragmatic Physiology Similarity Index (DPSI) and observe its behavior. The study will characterize DPSI features in healthy volunteers and in adults with acute respiratory failure, and will record DPSI changes across different HFNC flow settings during a standardized high-flow adjustment sequence. Secondary work will measure feasibility, inter-operator reproducibility, diaphragmatic contraction synchrony, end-diaphragmatic residual contraction (EDRC), displacement velocity, and maximum displacement. All imaging and flow adjustments are performed at Sir Run Run Shaw Hospital with ICU patients and healthy adult comparators.

Why it matters

Potential benefit: If successful, DPSI-guided HFNC titration could help personalize noninvasive oxygen support, improving breathing comfort and potentially reducing the need for escalation to invasive ventilation.

How similar studies have gone: Prior small studies have shown that diaphragmatic speckle-tracking is feasible and can correlate with diaphragm function, but using a DPSI specifically to titrate HFNC flow is novel and not yet proven.

Who can join: the full rules

Show full inclusion / exclusion criteria
Feasibility and reproducibility:adult ICU patients

Methodology for diaphragmatic motion synchrony:healthy adults and adult ICU patients Between-group comparisons and flow-titration study

Inclusion Criteria:

1. Age ≥18 years old.
2. Clear diagnosis of respiratory failure requiring respiratory support.
3. Expected duration of respiratory support ≥24 hours or (high-flow/non-invasive ventilation) ≥48 hours.
4. 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:

1. Severe chest wall deformities or diaphragmatic paralysis.
2. End-stage disease with a predicted life expectancy of less than 24 hours.
3. Inability to acquire STE (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations).
4. Vulnerable groups other than critically ill patients/elderly/illiterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.

Where it's running

  • Sir Run Run shaw Hospital Zhejiang University
    Hangzhou, Zhejiang, China
    Recruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.