Intensive Care Units (ICUs), Spontaneous Breathing Test, Weaning Failure of Mechanical Ventilation, Weaning-induced Pulmonary Edema, Weaning Invasive Mechanical Ventilation
Conditions
Keywords
Humidified high flow, Cardiac ultrasound, Spontaneous breathing trial, T-Piece
Brief 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.
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.
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The ultrasound evaluator will re-read and measure cardiac indexes on anonymized loops.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials. | At the 5th minute from beginning of each spontaneous breathing trial (each breathing trial is 15 minutes) | An evaluator at the patient's bed will use the cardiac ultrasound probe. The patient will be installed in a semi-seated position and the E/E' index will be measured over 3 successive cardiac cycles if the patient is in sinus rhythm, or 5 successive cycles if the patient is in atrial fibrillation. The measurement is taken at the 5th minute of each spontaneous breathing trial. The cross-over order of trials will be randomized. Once the cardiac ultrasound loops have been recorded, a blinded evaluator will read back the ultrasound images, and his or her measurement will be used for the primary evaluation. |
Countries
France
Contacts
CONTACTGuillaume Fossat, Pt, Msc, PhD student
CONTACTElodie Pougoue
Outcome results
None listed