Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials (ATARI)

Centre Hospitalier Régional d'Orléans

Status: Enrolling

Conditions: Intensive Care Units (ICUs); Weaning Invasive Mechanical Ventilation; Weaning Failure of Mechanical Ventilation; Weaning-induced Pulmonary Edema; Spontaneous Breathing Test

Treatments: Diagnostic Test: Pressure Support Spontaneous Breathing trial; Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial; Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Study type: Interventional

Funder types: Other

Identifiers

NCT06923267

CHUO-2024-09

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 6 patient groups

EVS1-EVS2-EVS3 (specific order of procedures)

Experimental group

Description:

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

Treatment:

Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial

Diagnostic Test: Pressure Support Spontaneous Breathing trial

EVS1-EVS3-EVS2 (specific order of procedures)

Experimental group

Description:

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

Treatment:

Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial

Diagnostic Test: Pressure Support Spontaneous Breathing trial

EVS2-EVS3-EVS1 (specific order of procedures)

Experimental group

Description:

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

Treatment:

Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial

Diagnostic Test: Pressure Support Spontaneous Breathing trial

EVS2-EVS1-EVS3 (specific order of procedures)

Experimental group

Description:

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

Treatment:

Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial

Diagnostic Test: Pressure Support Spontaneous Breathing trial

EVS3-EVS1-EVS2 (specific order of procedures)

Experimental group

Description:

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

Treatment:

Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial

Diagnostic Test: Pressure Support Spontaneous Breathing trial

EVS3-EVS2-EVS1 (specific order of procedures)

Experimental group

Description:

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

Treatment:

Diagnostic Test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Diagnostic Test: Humidified High Flow Spontaneous Breathing Trial

Diagnostic Test: Pressure Support Spontaneous Breathing trial