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

Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study

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.

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Breathing Test; Intensive Care Units (ICUs); Weaning-induced Pulmonary Edema; Weaning Failure of Mechanical Ventilation; Weaning Invasive Mechanical Ventilation
• Intervention / Treatment: Diagnostic test: No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial; Diagnostic test: Pressure Support Spontaneous Breathing trial; Diagnostic test: Humidified High Flow Spontaneous Breathing Trial

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elodie Pougoue; Phone Number: +33238744086; Email: elodie.pougoue-touko@chu-orleans.fr
• Study Contact Backup: Name: Guillaume Fossat, Pt, Msc, PhD Student; Phone Number: +33238651318; Email: guillaume.fossat@chu-orleans.fr

Study Locations

• France
  • Orléans, France, 45067
    • Recruiting
    • CHU Orléans
    • Contact: Guillaume Fossat, Pt, Msc, PhD Student; Phone Number: +33238651318; Email: guillaume.fossat@chu-orleans.fr
    • Principal Investigator: Mai-Anh NAY, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasonographic evaluation of cardio E/E' index during 3 randomly assigned cross-over spontaneous breathing trials.	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.	At the 5th minute from beginning of each spontaneous breathing trial (each breathing trial is 15 minutes)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Spontaneous breathing trial; Humidified high flow; Cardiac ultrasound; T-Piece
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pulmonary Edema; Respiratory Aspiration
• Other Study ID Numbers: CHUO-2024-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No