Using lung ultrasound to guide fluid management in ICU patients on mechanical ventilation

Effect of Lung Ultrasound-Guided Fluid Deresuscitation on Duration of Ventilation in Intensive Care Unit Patients (CONFIDENCE)

This study is testing if using lung ultrasound to manage fluids can help critically ill patients on ventilators breathe easier and get off the machines faster compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 3 sites (Arnhem, Gelderland and 2 other locations)
• Trial ID: NCT05188092 on ClinicalTrials.gov

What this trial studies

This international multicenter randomized clinical trial aims to evaluate the effectiveness of lung ultrasound (LUS)-guided fluid deresuscitation compared to standard fluid management in critically ill patients on invasive mechanical ventilation. The study will enroll 1,000 adult ICU patients who are expected to remain on ventilation for more than 24 hours. Participants will be randomly assigned to either the LUS-guided intervention group or the control group receiving routine care. The primary outcome is the duration of invasive ventilation, with the hypothesis that LUS guidance will lead to a reduction in this duration.

Who should consider this trial

Good fit: Ideal candidates are adult ICU patients who are invasively ventilated and expected to remain on ventilation for more than 24 hours.

Not a fit: Patients who are under 18 years old, pregnant, or have conditions that complicate the use of lung ultrasound will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the time patients spend on mechanical ventilation, improving recovery times and outcomes.

How similar studies have performed: Other studies have shown promising results with ultrasound-guided interventions in critical care, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Admission to one of the participating ICUs;
* Invasively ventilated for less than 24 hours at randomization;
* Expected to be under invasive ventilation for longer than 24 hours after randomization.

Exclusion Criteria:

* Age below 18 years old;
* Suspected or confirmed pregnancy;
* Participation in other interventional trials with similar endpoints;
* Use of long term home mechanical ventilation;
* Neurological condition that can prolong duration of mechanical ventilation (i.e.Guillain-Barré syndrome, high spinal cord lesion, amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis);
* Conditions in which LUS cannot be performed or correctly interpreted (i.e. chest wall abnormalities, morbid obesity, and pre-existing interstitial lung disease);
* Conditions in which targeting a negative fluid balance is discouraged (i.e. subarachnoid bleeding, severe rhabdomyolysis (CK \> 20.000);
* Previous participation in this RCT;
* Patients transferred from another center and invasively ventilated for longer than 24 hours.

Where this trial is running

Arnhem, Gelderland and 2 other locations

• Rijnstate — Arnhem, Gelderland, Netherlands (Recruiting)
• Amsterdam UMC, location VUMC — Amsterdam, North Holland, Netherlands (Recruiting)
• Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Marcus J Schultz, Prof — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Study coordinator: Amne Mousa, MSc

Conditions Mechanical Ventilation; Fluid Overload; Deresuscitation; Ventilator-free Days