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RecruitingNCT07751237DUS-WEANUpdated Aug 7, 2026

Diaphragmatic Ultrasonography in Difficult Weaning

An interventional study of Diaphragmatic ultrasound in Weaning Mechanical Ventilation, ICU Ill Patients and Diaphragm Dysfunction, sponsored by Hospital de Clinicas de Porto Alegre. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Weaning from mechanical ventilation (MV) is a gradual process that includes several steps until the complete withdrawal of ventilatory support. Difficult weaning is defined as weaning completed only after the first attempt to withdraw the patient from ventilatory support, that is, a patient who failed the first spontaneous breathing trial (SBT). The use of ultrasound (US) to assess diaphragmatic and extradiaphragmatic muscles, such as the parasternal muscles, has been employed to determine diaphragmatic dysfunction and ventilatory effort, contributing to the decision-making process regarding weaning. Among the tools used for bedside monitoring and evaluation of patients are ventilatory variables that indicate an adequate level of ventilatory assistance in spontaneous modes through ventilatory drive, such as P0.1 (occlusion pressure in the first 100 ms) and assessment of ventilatory effort-inspiratory muscle pressure (Pmus)-which have also contributed to the downscaling of ventilatory support. However, there is still no consensus in the literature regarding predicted values or the effective role of these tools as predictors of weaning during the spontaneous breathing trial (SBT). The available studies investigating the relationship between diaphragmatic US, through measurements of diaphragmatic excursion and thickening fraction, and weaning failure from mechanical ventilation are mostly observational, which limits the strength of the current evidence. Therefore, it is essential to conduct randomized clinical trials, which are still unprecedented on this topic, to more robustly assess the efficacy of this technique as a decision-support tool during the weaning process, thereby contributing to more precise clinical practice. OBJECTIVES: The primary objective of this study is to evaluate the effect of diaphragmatic US use on ventilator-free days in patients with difficult weaning. The secondary objective is to analyze the relationship between the ventilatory variables P0.1 and Pmus, diaphragmatic US, and parasternal muscle recruitment during the SBT. METHODS: This is a randomized clinical trial, following CONSORT recommendations, which will be prospectively registered on the ClinicalTrials platform. Patients will be included after failing the first SBT. Subsequently, they will be randomized into two groups: In the shared US group, the results of diaphragmatic assessment via US will be shared with the attending team for decision-making regarding extubation. In the second group, the non-shared US group, the attending team will not have access to the diaphragmatic assessment for decision-making. EXPECTED RESULTS: It is expected that the shared US group of patients will have a shorter duration of MV and a lower number of extubation failures.

02

Conditions studied

  • Weaning Mechanical Ventilation
  • ICU Ill Patients
  • Diaphragm Dysfunction

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Keywords

  • ultrasound Diaphragm
  • complicated weaning
  • Critical Illness
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults patients receiving invasive mechanical ventilation who are classified as having difficult weaning, defined as failure of the first spontaneous breathing trial.
  • Richmond Agitation-Sedation Scale (RASS) score between -2 and +1.
  • Clinical stability, defined as:
  • No vasopressor support or only low-dose, stable vasopressor therapy.
  • Absence of significant cardiac arrhythmias or ongoing myocardial ischemia.
  • Adequate oxygenation (SpO₂ >90% or PaO₂ >60 mmHg).
  • Respiratory rate \<35 breaths/min.

Exclusion criteria

Exclusion Criteria:

  • Inability to obtain informed consent.
  • Pre-existing neuromuscular disease.
  • Pregnancy.
  • Inability to perform the ultrasound examination because of chest drains, surgical wounds, or skin lesions at the assessment sites.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Shared US group

    In the shared US group, when indicators of diaphragmatic dysfunction are present-Dtf \< 30% and DE \< 1.0 cm-the research team will notify the attending clinical team and suggest the use of preventive non-invasive ventilation (NIV) for more than 48 hours after extubation.

    Diagnostic Test: Diaphragmatic ultrasound

  • Other
    Non-shared US group

    In this group, patients will be assessed; however, the results of the assessment will not be shared with the attending teams.

    Diagnostic Test: Diaphragmatic ultrasound

Interventions

  • Diagnostic testDiaphragmatic ultrasound

    Diaphragmatic excursion (DE) will be assessed using a low-frequency convex transducer (2-6 MHz) positioned in the anterior subcostal region between the midclavicular and anterior axillary lines. In B-mode, a transverse scan will be performed through the liver, allowing visualization of the right hemidiaphragm as a thick, curved, hyperechoic line. The ultrasound system will then be switched to M-mode to measure maximal diaphragmatic excursion. The mean DE will be calculated from three consecutive respiratory cycles. The diaphragmatic thickening fraction (DTF) requires measurement of diaphragm thickness at end-inspiration (Tdi) and end-expiration (Tde). Measurements will be obtained in B-mode by tracing the distance between the inner pleural and peritoneal echogenic lines. A high-frequency linear transducer (7-13 MHz) will be positioned at the zone of apposition (ZOA), between the 8th and 9th intercostal spaces, along the anterior to midaxillary line.

05

What researchers measure

Primary outcomes

  1. Ventilator-free days at day 28

    In relation to diaphragmatic muscle function as determined by ultrasound parameters obtained during the spontaneous breathing trial (SBT) in patients with difficult weaning.

    Time frame: At day 28

06

Study locations

1 of 1 sites recruiting
  • Hospital de Clínica de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07751237
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Aug 2026 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Sep 2029 (estimated)
Last update
Aug 7, 2026

Study contacts

Cassiano Teixeira, Doctor
Contact
cassiano.rush@gmail.com
+55 51 999687962
Josehelen Do Martini, Master
Contact
Jdmartini@hcpa.edu.br
+55 51 985442212
Cassiano Teixeira, Doctor
principal investigator · Hospital de Clínicas de Porto Alegre - RS, Brasil

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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