Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial, Pressure Support Spontaneous Breathing trial, Humidified High Flow Spontaneous Breathing Trial.
- Who it may be relevant to
- Registry conditions: Weaning Invasive Mechanical Ventilation, Weaning-induced Pulmonary Edema, Weaning Failure of Mechanical Ventilation, Spontaneous Breathing Test. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study
Overview
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.
Interventions
- Diagnostic test No 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 test Pressure 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 test Humidified 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.
Primary outcome measures
- Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials. [Time frame: At the 5th minute from beginning of each spontaneous breathing trial (each breathing trial is 15 minutes)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Chu Orleans — Orléans
Identifiers
NCT: NCT06923267 · CHUO-2024-09