Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation
Recruiting now · Not applicable
Conditions studied: Mucus Retention, Mechanical Ventilation Complication
In brief
Retention of airway secretions is a frequent complication in critically ill patients requiring invasive mechanical ventilation (MV).This complication is often due to excessive secretion production and ineffective secretion clearance. Mechanical insufflator-exsufflator (MI-E) is a respiratory physiotherapy technique that aims to assist or simulate a normal cough by using an electro-mechanical dedicated device. A positive airway pressure is delivered to the airways, in order to hyperinflate the lungs, followed by a rapid change to negative pressure that promotes a rapid exhalation and enhances peak expiratory flows. However, there is no consensus on the best MI-E settings to facilitate secretion clearance in these patients. Inspiratory and expiratory pressures of ±40 cmH2O and inspiratory-expiratory time of 3 and 2 seconds, respectively, are often used as a standard for MI-E programming in the daily routine practice, but recent laboratory studies have shown significant benefits when MI-E setting is optimized to promote an expiratory flow bias. The investigators designed this study to compare the effects of MI-E with an optimized setting versus a standard setting on the wet volume of suctioned sputum in intubated critically ill patients on invasive MV for more than 48 hours.
Key facts
- Study ID
- NCT06491017
- Run by
- Hospital Clinic of Barcelona
- People needed
- 26
- Starts
- 2026-05-08
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Hospital Clinic de Barcelona — Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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