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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Sir Run Run Shaw Hospital Academic / other |
| Locations | 2 sites (Hangzhou, Zhejiang and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | December 30, 2025 |
| Study ends | December 2, 2026 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT06996665 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
- Study coordinator: Huiqing Ge
- Email: gehq@zju.edu.cn
- Phone: +86 13588706787
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
HFNC During Bronchoscopy for Respiratory Failure
This study tests whether using high-flow nasal oxygen during fiber-optic bronchoscopy is safe and helpful for patients with respiratory failure.
-
Respiratory progression in adults with Duchenne muscular dystrophy: a long-term observational study
This study tests how respiratory function changes over three years in adults with genetically confirmed Duchenne muscular dystrophy.
-
Epidural spinal cord stimulation to help breathing after cervical spinal cord injury
This trial tests whether adding epidural spinal cord stimulation to standard care can improve breathing in adults with cervical spinal cord injury and respiratory failure.
-
Brain blood flow and brain regulation in critically ill kids
This study tests how blood flow in the brain behaves in critically ill children using a noninvasive ultrasound (TCD) to see if brain autoregulation patterns relate to outcomes.
-
Ciprofol versus propofol for sedating adult ICU patients on noninvasive respiratory support
See if ciprofol works better than propofol for sedating adults in the ICU who are receiving noninvasive ventilation, high-flow nasal cannula, or oxygen therapy.
-
Using EEG to monitor sleep quality in ICU patients with respiratory failure
We will test whether continuous EEG monitoring can better track sleep quality than nurse observations in conscious adults hospitalized in the ICU for acute respiratory failure.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.