Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The ultrasound evaluator will re-read and measure cardiac indexes on anonymized loops.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
EVS1-EVS2-EVS3 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial (Diagnostic Test)
EVS1-EVS2-EVS3 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Pressure Support Spontaneous Breathing trial (Diagnostic Test)
EVS1-EVS2-EVS3 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Humidified High Flow Spontaneous Breathing Trial (Diagnostic Test)
EVS1-EVS3-EVS2 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial (Diagnostic Test)
EVS1-EVS3-EVS2 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Pressure Support Spontaneous Breathing trial (Diagnostic Test)
EVS1-EVS3-EVS2 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Humidified High Flow Spontaneous Breathing Trial (Diagnostic Test)
EVS2-EVS3-EVS1 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial (Diagnostic Test)
EVS2-EVS3-EVS1 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Pressure Support Spontaneous Breathing trial (Diagnostic Test)
EVS2-EVS3-EVS1 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Humidified High Flow Spontaneous Breathing Trial (Diagnostic Test)
EVS2-EVS1-EVS3 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial (Diagnostic Test)
EVS2-EVS1-EVS3 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Pressure Support Spontaneous Breathing trial (Diagnostic Test)
EVS2-EVS1-EVS3 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Humidified High Flow Spontaneous Breathing Trial (Diagnostic Test)
EVS3-EVS1-EVS2 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial (Diagnostic Test)
EVS3-EVS1-EVS2 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Pressure Support Spontaneous Breathing trial (Diagnostic Test)
EVS3-EVS1-EVS2 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Humidified High Flow Spontaneous Breathing Trial (Diagnostic Test)
EVS3-EVS2-EVS1 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial (Diagnostic Test)
EVS3-EVS2-EVS1 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Pressure Support Spontaneous Breathing trial (Diagnostic Test)
EVS3-EVS2-EVS1 (specific order of procedures)
EVS1: Humidified High Flow Spontaneous Breathing Trial EVS2: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial EVS3: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial
干预措施: Humidified High Flow Spontaneous Breathing Trial (Diagnostic Test)
结局指标
主要结局
Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials.
时间窗: 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.
次要结局
未报告次要终点