Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study
NCT ID: NCT06996665
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2025-06-01
2026-12-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Early Extracorporeal Diaphragm Pacing Combined With Tilt Table in Ventilated Patients.
NCT05953649
Personalized Ultrasound-Guided External Diaphragm Pacing to Improve Outcomes in Invasive Mechanically Ventilated Patients
NCT06609577
Study of Diaphragmatic Ultrasound as a Predictor of Mechanical Ventilation in Patients With Respiratory Diseases on Admission to Intensive Care Unit
NCT06254417
Pleural Strain by Speckle-Tracking Ultrasound: Feasibility and Driving Pressure Associations
NCT06911450
Impact of PEEP Trials on Ventilation-Perfusion Matching in ARDS Patients
NCT06823804
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Feasibility Patient Cohort（No Intervention / Diagnostic Test）
Participants undergo an assessment-only diagnostic intervention: diaphragmatic speckle-tracking ultrasound performed at predefined time points during routine care to evaluate feasibility and measurement properties (e.g., foundational speckle-tracking metrics and inter-/intra-operator reproducibility). Images of the bilateral zone of apposition are acquired and analyzed offline for the contraction synchrony index, end-diaphragmatic residual contraction (EDRC), displacement velocity, and maximal displacement. Ultrasound findings are not used for clinical decision-making; respiratory support (e.g., HFNC/ventilator settings) is determined independently by the treating clinicians.
No interventions assigned to this group
Healthy Volunteer Reference Cohort
Healthy volunteers undergo protocolized, assessment-only diaphragmatic speckle-tracking ultrasound to characterize normal diaphragmatic physiology and establish reference ranges; no feasibility or reproducibility endpoints are collected. Bilateral zone-of-apposition images are acquired and analyzed offline for DPSI, contraction synchrony index, end-diaphragmatic residual contraction (EDRC), displacement velocity, and maximal displacement. No therapeutic interventions are delivered, and participation does not alter clinical management.
No interventions assigned to this group
Sequence 1: 20-30-40-60 L/min
Participants receive HFNC flows 20→30→40→60 L/min across four periods. Each period maintains the assigned flow for a predefined steady window; FiO₂ is adjusted per routine to meet target SpO₂. At the end of each period, protocolized diaphragmatic speckle-tracking ultrasound (bilateral zone of apposition) is performed with offline analysis of DPSI, contraction synchrony index, EDRC, displacement velocity, and maximal displacement; vital signs, respiratory rate, comfort/tolerance, and oxygenation are recorded. Safety overrides (e.g., hypoxemia, distress, intolerance) permit clinicians to modify or terminate the period.
High-flow adjustment sequence
Delivers heated, humidified blended oxygen via HFNC with real-time titration based on diaphragmatic speckle-tracking metrics (e.g., DPSI, contraction synchrony). Flow is adjusted in predefined increments to reach target diaphragmatic physiology while FiO₂ is titrated to maintain target SpO₂. Ultrasound feedback is used for bedside decisions; safety triggers allow clinical override.
Sequence 2: 30-60-20-40 L/min
This sequence administers HFNC flows 30→60→20→40 L/min over four periods. Procedures mirror Sequence 1: predefined steady windows, routine FiO₂ titration, end-of-period speckle-tracking ultrasound with offline metrics (DPSI, synchrony, EDRC, displacement velocity, maximal displacement), and collection of vitals/oxygenation/tolerance; safety triggers allow clinical override.
High-flow adjustment sequence
Delivers heated, humidified blended oxygen via HFNC with real-time titration based on diaphragmatic speckle-tracking metrics (e.g., DPSI, contraction synchrony). Flow is adjusted in predefined increments to reach target diaphragmatic physiology while FiO₂ is titrated to maintain target SpO₂. Ultrasound feedback is used for bedside decisions; safety triggers allow clinical override.
Sequence 3: 40-20-60-30 L/min
Participants receive HFNC flows 40→20→60→30 L/min across four periods. A predefined steady window is maintained with routine FiO₂ adjustments. End-of-period speckle-tracking ultrasound is performed with the same offline metrics; vitals, respiratory rate, comfort/tolerance, and oxygenation are captured. Safety triggers enable clinical override.
High-flow adjustment sequence
Delivers heated, humidified blended oxygen via HFNC with real-time titration based on diaphragmatic speckle-tracking metrics (e.g., DPSI, contraction synchrony). Flow is adjusted in predefined increments to reach target diaphragmatic physiology while FiO₂ is titrated to maintain target SpO₂. Ultrasound feedback is used for bedside decisions; safety triggers allow clinical override.
Sequence 4: 60-40-30-20 L/min
HFNC flows are delivered 60→40→30→20 L/min over four periods. Each period preserves a steady observation window with routine FiO₂ titration; end-of-period speckle-tracking ultrasound is performed with offline analyses (DPSI, synchrony, EDRC, displacement velocity, maximal displacement), and vitals/oxygenation/tolerance are recorded. Safety overrides may be applied by the treating team.
High-flow adjustment sequence
Delivers heated, humidified blended oxygen via HFNC with real-time titration based on diaphragmatic speckle-tracking metrics (e.g., DPSI, contraction synchrony). Flow is adjusted in predefined increments to reach target diaphragmatic physiology while FiO₂ is titrated to maintain target SpO₂. Ultrasound feedback is used for bedside decisions; safety triggers allow clinical override.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
High-flow adjustment sequence
Delivers heated, humidified blended oxygen via HFNC with real-time titration based on diaphragmatic speckle-tracking metrics (e.g., DPSI, contraction synchrony). Flow is adjusted in predefined increments to reach target diaphragmatic physiology while FiO₂ is titrated to maintain target SpO₂. Ultrasound feedback is used for bedside decisions; safety triggers allow clinical override.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sir Run Run Shaw Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Huiqing Ge
Director of Respiratory Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Huiqing Ge
Role: STUDY_CHAIR
Sir Run Run Shaw Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sir Run Run shaw Hospital Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Goutman SA, Hamilton JD, Swihart B, Foerster B, Feldman EL, Rubin JM. Speckle tracking as a method to measure hemidiaphragm excursion. Muscle Nerve. 2017 Jan;55(1):125-127. doi: 10.1002/mus.25380. Epub 2016 Aug 22.
Santana PV, Cardenas LZ, Albuquerque ALP. Diaphragm Ultrasound in Critically Ill Patients on Mechanical Ventilation-Evolving Concepts. Diagnostics (Basel). 2023 Mar 15;13(6):1116. doi: 10.3390/diagnostics13061116.
Li R, Zhou Y, Chen W, Lyu L, Qiu G, Pan C, Tang Y. Speckle tracking ultrasound as a new tool to predict the weaning outcome of mechanical ventilation patients: a prospective observational study. Front Med (Lausanne). 2024 Dec 6;11:1449938. doi: 10.3389/fmed.2024.1449938. eCollection 2024.
Ye X, Liu Z, Ma Y, Song Y, Hu L, Luo J, Xiao H. A Novel Normalized Cross-Correlation Speckle-Tracking Ultrasound Algorithm for the Evaluation of Diaphragm Deformation. Front Med (Lausanne). 2021 Mar 12;8:612933. doi: 10.3389/fmed.2021.612933. eCollection 2021.
van den Berg MJW, Heunks L, Doorduin J. Advances in achieving lung and diaphragm-protective ventilation. Curr Opin Crit Care. 2025 Feb 1;31(1):38-46. doi: 10.1097/MCC.0000000000001228. Epub 2024 Nov 14.
Watanabe S, Sekiguchi K, Suehiro H, Yoshikawa M, Noda Y, Kamiyama N, Matsumoto R. Decreased diaphragm moving distance measured by ultrasound speckle tracking reflects poor prognosis in amyotrophic lateral sclerosis. Clin Neurophysiol Pract. 2024 Oct 22;9:252-260. doi: 10.1016/j.cnp.2024.10.002. eCollection 2024.
Xu Q, Yang X, Qian Y, Hu C, Lu W, Cai S, Hu B, Li J. Comparison of assessment of diaphragm function using speckle tracking between patients with successful and failed weaning: a multicentre, observational, pilot study. BMC Pulm Med. 2022 Dec 1;22(1):459. doi: 10.1186/s12890-022-02260-z.
Goligher EC, Jonkman AH, Dianti J, Vaporidi K, Beitler JR, Patel BK, Yoshida T, Jaber S, Dres M, Mauri T, Bellani G, Demoule A, Brochard L, Heunks L. Clinical strategies for implementing lung and diaphragm-protective ventilation: avoiding insufficient and excessive effort. Intensive Care Med. 2020 Dec;46(12):2314-2326. doi: 10.1007/s00134-020-06288-9. Epub 2020 Nov 2.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20250271
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.