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

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

Plain Language Summary

Simplified for easier understanding

This study is using ultrasound (heart and lung scanning) to monitor how the heart and lungs respond when patients on breathing machines attempt to breathe on their own — a critical step before removing the ventilator. The focus is on patients at high risk of needing re-intubation. **You may be eligible if...** - You have been on a mechanical ventilator for at least 24 hours - You are alert and relatively calm (RASS score between -1 and +1) - You are considered high-risk for breathing failure after the ventilator is removed, due to an underlying heart or lung condition **You may NOT be eligible if...** - You have a neuromuscular disease (like myasthenia gravis) that was present before hospitalization - You are pregnant or breastfeeding - You have previously failed a breathing trial in this hospitalization for non-cardiac reasons Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


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