NCT06996665 Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study
| NCT ID | NCT06996665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sir Run Run Shaw Hospital |
| Condition | Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-06-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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.
Eligibility 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.
Contact & Investigator
Huiqing Ge
STUDY CHAIR
Sir Run Run Shaw Hospital
Frequently Asked Questions
Who can join the NCT06996665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06996665 currently recruiting?
Yes, NCT06996665 is actively recruiting participants. Contact the research team at gehq@zju.edu.cn for enrollment information.
Where is the NCT06996665 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China.
Who is sponsoring the NCT06996665 clinical trial?
NCT06996665 is sponsored by Sir Run Run Shaw Hospital. The principal investigator is Huiqing Ge at Sir Run Run Shaw Hospital. The trial plans to enroll 100 participants.