NCT06491017 Effects of Mechanical Insufflation-Exsufflation With Optimized Settings on Wet Mucus Volume During Invasive Ventilation
| NCT ID | NCT06491017 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Clinic of Barcelona |
| Condition | Mucus Retention |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 26 participants in total. It began in 2026-05-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Joan Daniel Martí, PhD
PRINCIPAL INVESTIGATOR
Hospital Clinic of Barcelona
Frequently Asked Questions
Who can join the NCT06491017 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mucus Retention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06491017 currently recruiting?
Yes, NCT06491017 is actively recruiting participants. Contact the research team at jd.martibcn@gmail.com for enrollment information.
Where is the NCT06491017 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06491017 clinical trial?
NCT06491017 is sponsored by Hospital Clinic of Barcelona. The principal investigator is Joan Daniel Martí, PhD at Hospital Clinic of Barcelona. The trial plans to enroll 26 participants.