Actively Recruiting
Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation
Led by Hospital Clinic of Barcelona · Updated on 2026-05-08
26
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (over 18 years old)
- Endotracheal intubation and invasive mechanical ventilation for more than 48 hours
- Active humidification for more than 24 hours
- Sedation level between -3 and -5 on the Richmond Agitation-Sedation Scale
- Signed informed consent
You will not qualify if you...
- Hemodynamic instability (mean arterial pressure below 60 or above 110, heart rate below 50 or above 130, new arrhythmias)
- Respiratory instability (PEEP greater than 12 cmH2O, oxygen saturation below 90%, or inspired oxygen fraction over 60%)
- Undrained pneumothorax or pneumomediastinum
- Unstable intracranial pressure (ICP over 20 mmHg or MAP below 60)
- Severe bronchospasm
- Post cardiothoracic surgery patients
- Active pulmonary tuberculosis
- Bronchoesophageal or bronchopleural fistulas
- Prone positioning
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
Research Team
D
Dani M Romeu, PhD
CONTACT
G
Gonzalo Basllesteros Reviriego, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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