Respiratory FailureNCT06996665
Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study
A study testing High-flow adjustment sequence in people with Respiratory Failure, run by Sir Run Run Shaw Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- High-flow adjustment sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2025to 2 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years old.
- Clear diagnosis of respiratory failure requiring respiratory support.
- Expected duration of respiratory support ≥24 hours or (high-flow/non-invasive ventilation) ≥48 hours.
- 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.
Who cannot join
- Severe chest wall deformities or diaphragmatic paralysis.
- End-stage disease with a predicted life expectancy of less than 24 hours.
- Inability to acquire STE (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations).
- Vulnerable groups other than critically ill patients/elderly/illiterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sir Run Run shaw Hospital Zhejiang University
Hangzhou, Zhejiang, 310000
Huiqing Ge, +86 13588706787, gehq@zju.edu.cn
- Not yet recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Huiqing Ge, +86 13588706787, gehq@zju.edu.cn
About this study
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
Read more
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.
- Conditions
- Respiratory Failure
- Being tested
- High-flow adjustment sequence
- Keywords
- Diaphragm, Speckle Tracking, PEEP
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow adjustment sequenceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: High-flow adjustment sequence |
| 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. Receives: Other: High-flow adjustment sequence |
| 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. Receives: Other: High-flow adjustment sequence |
| 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. Receives: Other: High-flow adjustment sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Healthy Participants: Baseline； Baseline evaluation at the time of enrollment change with each change in ventilation parameters.
Secondary outcomes (7)
Adverse events including pneumothorax, hemodynamic instability, and other complications
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after the intervention, and daily morning assessments until extubation or day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jun 2025
- Primary completion30 Dec 2025
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqing Ge, Sir Run Run Shaw Hospital
- Investigators
- Huiqing Ge, Study chair, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996665
- Sponsor's protocol ID
- 20250271
- Status last verified
- Jul 2025
- First submitted
- 3 May 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27533320Santana 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.
PubMed 36980423Li 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.
PubMed 39712177Ye 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.
PubMed 33777969van 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.
PubMed 39560149Watanabe 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.
PubMed 39534515Xu 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.
PubMed 36456940Goligher 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.
PubMed 33140181
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06996665
- Acronym / sponsor ID
- 20250271
- Conditions
- Respiratory Failure
- Keywords
- Diaphragm, Speckle Tracking, PEEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: High-flow adjustment sequenceParticipants 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. |
| Sequence 2: 30-60-20-40 L/min | Experimental | Other: High-flow adjustment sequenceThis 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 | Other: High-flow adjustment sequenceParticipants 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 | Other: High-flow adjustment sequenceHFNC 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old.
- Clear diagnosis of respiratory failure requiring respiratory support.
- Expected duration of respiratory support ≥24 hours or (high-flow/non-invasive ventilation) ≥48 hours.
- 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.
Key exclusion criteria (4 listed)
- Severe chest wall deformities or diaphragmatic paralysis.
- End-stage disease with a predicted life expectancy of less than 24 hours.
- Inability to acquire STE (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations).
- Vulnerable groups other than critically ill patients/elderly/illiterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow adjustment sequenceDelivers 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. | Other | Sequence 1: 20-30-40-60 L/min, Sequence 2: 30-60-20-40 L/min, Sequence 3: 40-20-60-30 L/min, Sequence 4: 60-40-30-20 L/min |
Primary outcome
Diaphragmatic Physiology Similarity Index (DPSI)
Time frame: Healthy Participants: Baseline； Baseline evaluation at the time of enrollment change with each change in ventilation parameters.
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.
7 secondary outcomes
Adverse events including pneumothorax, hemodynamic instability, and other complications
Time frame: 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)
Time frame: 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
Time frame: After each HFNC flow adjustment: Measure contraction synchrony during each flow setting period.
ICC (Intraclass Correlation Coefficient)
Time frame: 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)
Time frame: 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
Time frame: 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.)
Time frame: At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after the intervention, and daily morning assessments until extubation or day 28.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 27533320Goutman 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.
- Background: PubMed 36980423Santana 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.
- Background: PubMed 39712177Li 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.
- Background: PubMed 33777969Ye 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.
- Background: PubMed 39560149van 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.
- Background: PubMed 39534515Watanabe 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.
- Background: PubMed 36456940Xu 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.
- Background: PubMed 33140181Goligher 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huiqing Ge study chair
Sir Run Run Shaw Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow adjustment sequence in people with Respiratory Failure, run by Sir Run Run Shaw Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huiqing Ge (+86 13588706787 ext. 3588706787, gehq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic Physiology Similarity Index (DPSI) (time frame: Healthy Participants: Baseline； Baseline evaluation at the time of enrollment change with each change in ventilation parameters.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06996665, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.