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NCT Number: NCT06923267

Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Orleans

Orléans, 45067, France

Location status: Recruiting

Location contact

Guillaume Fossat, Pt, Msc, PhD Student

CONTACT

[email protected]

+33238651318

Mai-Anh NAY, Dr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Pressure Support No Positive End Expiratory Pressure Spontaneous Breathing Trial

Diagnostic Test

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.

Pressure Support Spontaneous Breathing trial

Diagnostic Test

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.

Humidified High Flow Spontaneous Breathing Trial

Diagnostic Test

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 outcomes

  1. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie Pougoue

CONTACT

[email protected]

+33238744086

Guillaume Fossat, Pt, Msc, PhD student

CONTACT

[email protected]

+33238651318

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: ATARI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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