Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials

Recruiting · NCT06923267 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Régional d'Orléans

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Heart failure

Interventions studied

Humidified High Flow Spontaneous Breathing TrialNo Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing TrialPressure Support Spontaneous Breathing trial

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed.

Chu Orleans - Orléans, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →