Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06009731

Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial

Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric balloons is the gold standard for the assessment of diaphragmatic effort. This technique is relatively invasive and its interpretation may be complex. The diaphragmatic longitudinal strain (LSdi) and strain rate (LSRdi) might provide additional information in the assessment of diaphragmatic effort and movement during SBT, allowing early detection of diaphragmatic dysfunction. Patients will be monitored during a 30-120 minutes SBT consisting of no assistance on the ventilator using CPAP with a pressure level of 0 cmH2O. Parameters to evaluate diaphragm function will include diaphragmatic strain (LSdi and LSRdi), diaphragmatic thickening fraction (TFdi), and airway occlusion pressure (ΔP0.1 and ΔPocc). These parameters will be measured immediately before ('baseline') the SBT, as well as 2 minutes ('early' assessment), 15 ('intermediate' assessment) and 30 minutes ('late' assessment) after the beginning of the SBT.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Clement Brault, MD

CONTACT

Julien Maizel, Pr

SUB_INVESTIGATOR

Michel Slama, Pr

SUB_INVESTIGATOR

Yoann Zerbib, MD

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at least 24h (regardless of the reason of intubation)
  • patients fulfilling criteria for an SBT
  • patients will have to be able to trigger ventilator breaths with a reasonable level of assistance,
  • patients with lack of severe impairment in gas exchange,
  • patients that not require significant hemodynamic support.
  • Patients will be recruited by the study coordinator following completion of informed consent from the patient or legally authorized substitute decision maker.

Exclusion criteria

  • Use of pressure support during the SBT.
  • Severe hemodynamic instability (>30% increase in vasopressors in the last 6 hours or norepinephrine > 0.5 µg/kg/min).
  • Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 < 30% predicted).
  • Known or suspected severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence
  • Clinical judgement of the attending physician.

Treatment and study plan

Primary outcomes

  1. changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial

    Time frame: 7 days

    diaphragmatic longitudinal strain is LSdi Spontaneous breathing trial is SBT

  2. changes of diaphragmatic longitudinal strain strain rate between baseline and during Spontaneous breathing trial

    Time frame: 7 days

    diaphragmatic longitudinal strain strain rate is LSRdi Spontaneous breathing trial is SBT

Study contacts

Contact information is provided by the study sponsor or research team.

Clément Brault, MD

CONTACT

[email protected]

03 22 08 89 09

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: DIAST

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.