Actively Recruiting
Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study
Led by Centre Hospitalier Régional d'Orléans · Updated on 2026-05-22
24
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the changes in a cardiac ultrasound index called E/E' during three different spontaneous breathing trials in adults in the Intensive Care Unit (ICU) who are at risk for difficulty when stopping mechanical ventilation. The study aims to determine which breathing trial puts the least strain on the heart by comparing the effects of the three trials when performed in a random order. The study involves three types of spontaneous breathing trials: a humidified high flow trial with a ventilator set at 50 liters per minute, a trial with no pressure support and no positive end-expiratory pressure (PEEP) for 15 minutes, and a trial with pressure support set at 7 cmH2O and PEEP at 0 cmH2O for 15 minutes. Between breathing trials, participants have a 10-minute break to recover. The trials are performed while patients are connected to the ventilator or its specific setup for humidified flow. Participants will simply breathe without respiratory support during each trial while the researchers perform cardiac ultrasound measurements at the 5th minute of each 15-minute trial to assess heart function. The main measurement is the E/E' index from ultrasound. This study lasts through the duration of the three trials with monitoring and assessments done during each trial to understand the heart's workload under different breathing conditions.
CONDITIONS
Brief Title
Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial
- Richmond Agitation Sedation Scale (RASS) score between -1 and +1
- Patient at high risk of re-intubation with at least one of the following: underlying cardiac disease (left ventricular dysfunction with ejection fraction 45%, ischemic heart disease, chronic atrial fibrillation, or history of cardiogenic pulmonary edema)
- Patient at high risk of re-intubation with at least one of the following: underlying respiratory disease (COPD, emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, or restrictive lung disease)
You will not qualify if you...
- Neuromuscular pathology such as myasthenia gravis preceding hospitalization
- Pregnant or breastfeeding women
- Patient already included in the study
- Person under guardianship, curatorship, or court protection
- Person not affiliated to a social security scheme
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 day
Participants undergo three different spontaneous breathing trials in randomized order to evaluate cardiac function using ultrasound.
1 visit with three 15-minute spontaneous breathing trials separated by 10-minute washout periods
Trial Site Locations
Total: 1 location
1
Chu Orleans
Orléans, France, 45067
Actively Recruiting
Research Team
G
Guillaume Fossat, Pt, Msc, PhD student
E
Elodie Pougoue
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
6
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