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Search / Trial NCT06491017

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

Launched by HOSPITAL CLINIC OF BARCELONA · Jul 5, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Mechanical Insufflation Exsufflation Physiotherapy Mucus Retention Mechanical Ventilation

ClinConnect Summary

This clinical trial is investigating a technique called Mechanical Insufflation-Exsufflation (MI-E) to help clear mucus from the airways of critically ill patients who are on invasive mechanical ventilation. In simpler terms, the study aims to find out if using a specially designed machine with optimized settings can help remove more mucus compared to standard settings. This is important because many patients on ventilators struggle with excessive mucus, which can make it harder for them to breathe.

To participate in this trial, individuals must be adults over 18 years old who have been intubated and receiving mechanical ventilation for more than 48 hours. They should also have been receiving humidification for at least 24 hours and have a certain level of sedation. However, some patients will not be eligible, such as those with unstable heart or respiratory conditions, recent heart surgery, or pregnancy. Participants can expect to have their mucus levels measured and compared between the two different MI-E settings during their time in the study. This research could lead to improved care for patients with difficult mucus clearance in the future.

Gender

ALL

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.

About Hospital Clinic Of Barcelona

The Hospital Clinic of Barcelona is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a strong emphasis on multidisciplinary collaboration, the hospital integrates cutting-edge medical practices with rigorous scientific inquiry to enhance patient outcomes. As a prominent sponsor of clinical trials, the Hospital Clinic of Barcelona is dedicated to exploring new therapies and treatment modalities across various medical fields, fostering a culture of excellence in clinical research that ultimately aims to improve the quality of care for patients locally and globally.

Locations

Barcelona, , Spain

Patients applied

0 patients applied

Trial Officials

Joan Daniel Martí, PhD

Principal Investigator

Hospital Clinic of Barcelona

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported