NCT06923267

Ultrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-30
• Primary completion: 2026-04-09
• Completion: 2026-05-01
• First posted: 2025-04-11
• Last updated: 2025-05-15

Locations

1 site across 1 country: France