Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06491017

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

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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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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