Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials

Not Applicable

Recruiting

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

• Registration Number: NCT06923267
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-11
• Study Start: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-04-09
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chu Orleans; 🇫🇷 Orleans, France