RecruitingNot ApplicableNCT06923267

Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials

Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study

Sponsor

Centre Hospitalier Régional d'Orléans

Enrollment

24 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

Weaning Invasive Mechanical Ventilation Weaning-induced Pulmonary Edema Weaning Failure of Mechanical Ventilation Spontaneous Breathing Test Intensive Care Units (ICUs)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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

Interventions

DIAGNOSTIC_TESTNo Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing both the positive end-expiratory pressure (PEEP) and the pressure support to 0 cmH2O, for 15 minutes.

DIAGNOSTIC_TESTPressure Support Spontaneous Breathing trial

The spontaneous breathing test is carried out with the patient connected to the ventilator, reducing the positive end-expiratory pressure (PEEP) to 0 cmH2O and the pressure support to 7 cmH2O, for 15 minutes. A 10-minute washout period is left before the start of the next SBT modality.

DIAGNOSTIC_TESTHumidified High Flow Spontaneous Breathing Trial

The spontaneous breathing trial is carried out with humidified high flow ventilator mode set at 50 liters per minute for 15 minutes. The patient will be connected to the ventilator via a specific connector enabling the administration of humidified high flow. A 10-minute washout period is left before the start of the next SBT modality.

Locations(1)

Chu Orleans

Orléans, France

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NCT06923267