Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility Patient Cohort(No Intervention / Diagnostic Test) | No Intervention | 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. | |
| Healthy Volunteer Reference Cohort | No Intervention | 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. | |
| Sequence 1: 20-30-40-60 L/min | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow adjustment sequence | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragmatic Physiology Similarity Index (DPSI) | The objective of this prospective observational study is to explore the Diaphragmatic Physiology Similarity Index (DPSI), derived from speckle tracking ultrasound, in guiding the adjustment of high-flow nasal cannula (HFNC) flow settings, and to assess its application in patients with acute respiratory failure. | Healthy Participants: Baseline; Baseline evaluation at the time of enrollment change with each change in ventilation parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events including pneumothorax, hemodynamic instability, and other complications | At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28. | |
| Arterial blood gas analysis (ABG analysis) |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqing Ge | Contact | +86 13588706787 | 3588706787 | gehq@zju.edu.cn |
| Yiqing Xu | Contact | +86 13634115344 | xuyiqing@srrsh.com |
| Name | Affiliation | Role |
|---|---|---|
| Huiqing Ge | Sir Run Run Shaw Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run shaw Hospital Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27533320 | Background | 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. | |
| 36980423 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sequence 2: 30-60-20-40 L/min | Experimental | 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. |
|
| Sequence 3: 40-20-60-30 L/min | Experimental | 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. |
|
| Sequence 4: 60-40-30-20 L/min | Experimental | 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. |
|
|
| At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28. |
| Diaphragmatic Contraction Synchrony Index | Evaluate the diaphragmatic contraction synchrony index, assessing the degree to which the diaphragm contracts as a coordinated unit. | After each HFNC flow adjustment: Measure contraction synchrony during each flow setting period. |
| ICC (Intraclass Correlation Coefficient) | Evaluate the feasibility and inter-operator reproducibility of diaphragmatic speckle tracking ultrasound. | At each ultrasound assessment, record the percentage of analyzable images. Compare measurements at the beginning and throughout the study among operators. |
| Evaluation of End-Diaphragmatic Residual Contraction (EDRC) | Assess the residual contraction of the diaphragm after mechanical ventilation to understand its recovery ability. | After each mechanical ventilation period: Measure EDRC at the end of the mechanical ventilation phase, noting the diaphragm's ability to recover. |
| Diaphragmatic Displacement Velocity and Maximum Displacement | Displacement Velocity: The speed at which the diaphragm moves during each breath cycle. Maximum Displacement: The maximum distance the diaphragm moves during inhalation and exhalation. | At each flow setting change: Measure the diaphragm's displacement velocity and maximum displacement at each HFNC flow rate adjustment. |
| Diaphragmatic ultrasound parameters (maximum displacement, thickening fraction, etc.) | At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after the intervention, and daily morning assessments until extubation or day 28. |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| 39712177 | Background | 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. |
| 33777969 | Background | 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. |
| 39560149 | Background | 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. |
| 39534515 | Background | 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. |
| 36456940 | Background | 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. |
| 33140181 | Background | 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. |