Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Weaning, Spontaneous Breathing Trial, Mechanical Ventilation, Speckle Tracking. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DIAPHRAGMATIC SPECKLE TRACKING DURING SPONTANEOUS BREATHING TRIAL
Overview
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.
Primary outcome measures
- changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial [Time frame: 7 days]
- changes of diaphragmatic longitudinal strain strain rate between baseline and during Spontaneous breathing trial [Time frame: 7 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT06009731 · PI2023_843_0040