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Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Régional d'Orléans
NCT06923267 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate the evolution of a cardiac ultrasound index (E/E') during 3 spontaneous breathing trials in Intensive Care Unit (ICU) adults (over 18 years) patients at risk for weaning failure. The main objective is to find out which spontaneous breathing trial is the least demanding in terms of heart work. Investigators will compare 3 consecutive spontaneous breathing trials in a random order to see if one is superior to the others. Participants will not have to perform any specific procedure apart from breathing without respiratory support during the spontaneous breathing trial. During these trials, the investigator will perform cardiac ultrasound measurements.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial * Richmond Agitation Sedation Scale (RASS) between -1 and +1 * Patient at high risk of re-intubation with at least one of the following criteria: * Underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema) * Underlying respiratory disease (COPD, Emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, restrictive lung disease) Exclusion Criteria: * Neuromuscular pathology (myasthenia type) preceding hospitalization * Pregnant or breast-feeding women * Patient already included in the study * Protected person (under guardianship or curatorship) * Person under court protection * Person not affiliated to a social security scheme
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What it tests

  • No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
  • Pressure Support Spontaneous Breathing trial
  • Humidified High Flow Spontaneous Breathing Trial
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Where

1 site
Chu Orleans
Orléans, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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