Using a mechanical cough-assist with optimized settings to reduce mucus in adults on ventilators

Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Suctioned Wet Mucus Volume During Invasive Ventilation

This will test whether using optimized mechanical insufflation-exsufflation (MI-E) settings helps clear wet mucus in adults who are intubated and receiving invasive mechanical ventilation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Clinic of Barcelona (Academic / other)
• Locations: 1 site (Barcelona)
• Trial ID: NCT06491017 on ClinicalTrials.gov

What this trial studies

This interventional study compares an MI-E protocol with optimized inspiratory/expiratory pressures and timing against standard MI-E settings in intubated, sedated adult ICU patients. The trial enrolls patients who have been invasively ventilated for more than 48 hours and measures wet mucus volume collected during treatment sessions. Physiotherapists deliver MI-E delivered via the endotracheal tube while monitoring respiratory and hemodynamic stability and predefined safety limits. Outcomes focus on secretion clearance and immediate respiratory effects during invasive mechanical ventilation.

Who should consider this trial

Good fit: Adults over 18 who are endotracheally intubated and invasively ventilated for more than 48 hours with active humidification for over 24 hours and who are sedated to RASS -3 to -5 may be eligible.

Not a fit: Patients with hemodynamic or respiratory instability, high PEEP or FiO2 requirements, undrained pneumothorax, severe bronchospasm, recent cardiothoracic surgery, fistulas, active tuberculosis, prone positioning, or pregnancy are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the optimized MI-E settings could improve secretion clearance, reduce atelectasis and respiratory infections, and potentially shorten time on mechanical ventilation.

How similar studies have performed: Laboratory and small physiotherapy studies have suggested benefits from adjusted MI-E pressures and timing, but robust clinical evidence in invasively ventilated ICU patients is limited and there is no consensus on optimal settings.

Eligibility criteria

Inclusion Criteria:

* Adults (\> 18yo).
* Endotracheal intubation and invasive mechanical ventilation for \> 48h and active humidification for \> 24h.
* Richmond Agitation-Sedation Scale -3 to -5.
* Signed informed consent.

Exclusion Criteria:

* Patients with hemodynamic instability (MAP \< 60 or \> 110, Heart Rate \< 50 or \> 130, new onset arrhythmias), respiratory instability (PEEP \> 12cmH2O, SpO2 \< 90% or fraction of inspired oxygen (FiO2) \> 60%).
* Undrained pneumothorax/pneumomediastinum.
* Unstable intracranial pressure (ICP \> 20mmHg or MAP \< 60).
* Severe bronchospasm.
* Post cardiothoracic surgical patients.
* Active pulmonary tuberculosis.
* Bronchoesophageal or bronchopleural fistulas.
* Prone position.
* Pregnancy.

Where this trial is running

Barcelona

• Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)

Study contacts

• Principal investigator: Joan Daniel Martí, PhD — Hospital Clinic of Barcelona
• Study coordinator: Dani M Romeu, PhD

Conditions Mucus Retention; Mechanical Ventilation Complication; Mechanical insufflation-exsufflation; Physiotherapy; Mucus retention; mechanical ventilation