Clinical trial NCT06996665: Diaphragmatic Speckle Tracking to Guide Diaphragm-Protective Ventilatory Support: A Study of Feasibility and Efficacy.
Official title: Feasibility and Efficacy of Diaphragmatic Speckle Tracking in Guiding Diaphragm-Protective Ventilatory Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Failure
Keywords: Diaphragm
Speckle Tracking
PEEP
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of diaphragmatic speckle tracking ultrasound in guiding diaphragm-protective ventilation in mechanically ventilated patients, and to assess its impact on extubation success rates and diaphragmatic function preservation. The main research questions include:

Can diaphragmatic speckle tracking ultrasound improve diaphragmatic function and reduce the risk of complications associated with mechanical ventilation?

Can real-time adjustment of ventilation parameters based on speckle tracking feedback improve extubation success rates?

Researchers will compare the PEEP strategy guided by diaphragmatic speckle tracking ultrasound with conventional PEEP settings in mechanical ventilation to evaluate the effectiveness of this novel approach in preserving diaphragmatic function and improving patient outcomes.

Participants will:

Receive either ultrasound-guided ventilation or conventional ventilation daily during mechanical ventilatory support.

Keep a daily record of symptoms, ventilation adjustments, and extubation outcomes.


Eligibility criteria: 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.

Primary outcomes:
measure: Total MV duration (h)
timeFrame: through study completion, an average of 1 month
measure: First successful extubation time
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 months.
measure: Incidence of ventilator-associated events (VAE)
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Adverse events including pneumothorax, hemodynamic instability, and other complications
timeFrame: At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.
measure: Arterial blood gas analysis (ABG analysis)
timeFrame: At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.
measure: EIT monitoring of regional ventilation distribution (center-to-periphery ventilation ratio)
timeFrame: At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.
measure: TGF-β1 in blood samples
timeFrame: At baseline (upon enrollment) and extubation or day 28
measure: Diaphragmatic ultrasound parameters (maximum displacement, thickening fraction, etc.)
timeFrame: At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after the intervention, and daily morning assessments until extubation or day 28.
measure: Transpulmonary pressure
timeFrame: At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after the intervention, and daily morning assessments until extubation or day 28.
measure: Grem2 in blood samples
timeFrame: At baseline (upon enrollment) and extubation or day 28
measure: Smad3 in blood samples
timeFrame: At baseline (upon enrollment) and extubation or day 28
Other outcomes:
Locations:
city: Hang Zhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Huiqing Ge
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.