Health TrialsbyHealthPanel

Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study

ConditionRespiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSir Run Run Shaw Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • High-flow adjustment sequence

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Feasibility Patient Cohort（No Intervention / Diagnostic Test）No intervention 0 interventions
Group B: Healthy Volunteer Reference CohortNo intervention 0 interventions
Group C: Sequence 1: 20-30-40-60 L/minExperimental treatment 1 intervention
Group D: Sequence 2: 30-60-20-40 L/minExperimental treatment 1 intervention
Group E: Sequence 3: 40-20-60-30 L/minExperimental treatment 1 intervention
Group F: Sequence 4: 60-40-30-20 L/minExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Healthy Participants: Baseline； Baseline evaluation at the time of enrollment change with each change in ventilation parameters.

Secondary outcomes

1

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.
2

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.
3

Diaphragmatic Contraction Synchrony Index

Evaluate the diaphragmatic contraction synchrony index, assessing the degree to which the diaphragm contracts as a coordinated unit.

Time frame
After each HFNC flow adjustment: Measure contraction synchrony during each flow setting period.
4

ICC (Intraclass Correlation Coefficient)

Evaluate the feasibility and inter-operator reproducibility of diaphragmatic speckle tracking ultrasound.

Time frame
At each ultrasound assessment, record the percentage of analyzable images. Compare measurements at the beginning and throughout the study among operators.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sir Run Run Shaw Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now