Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06491017

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

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of mechanical insufflation-exsufflation (MI-E) with optimized settings compared to standard settings on the volume of wet mucus suctioned in critically ill patients who require invasive mechanical ventilation (MV) for more than 48 hours. The study addresses retention of airway secretions, a common complication caused by excessive mucus and ineffective clearance, which can lead to serious lung problems and increased risks for these patients. The goal is to find better MI-E settings to help clear secretions more effectively, improving patient outcomes in intensive care. The study compares two MI-E approaches: an optimized setting tailored to achieve inspiratory volumes of at least 1 liter and peak expiratory flow (PEF) of at least 80 L/min, and a standard setting using fixed inspiratory and expiratory pressures of +40/-40 cmH2O with set timing cycles. Both settings use a mechanical device to simulate coughing by delivering positive pressure to inflate the lungs followed by rapid negative pressure to enhance mucus clearance. Each intervention includes 4 sets of 5 breathing cycles with breaks to maintain oxygen levels. Participants will be monitored closely during the interventions with measurements including sputum volume suctioned immediately after treatment, respiratory parameters like inspiratory and peak expiratory flow, lung mechanics, heart rate, blood pressure, and oxygen levels before and after procedures. Safety is tracked by recording any adverse events during and immediately after interventions. The study runs until December 2028 and is designed to gather detailed data to help improve respiratory care for ventilated patients.

CONDITIONS

Brief 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
  • Richmond Agitation-Sedation Scale score between -3 and -5
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Hemodynamic instability (mean arterial pressure less than 60 or greater than 110, heart rate less than 50 or greater than 130, new onset arrhythmias)
  • Respiratory instability (PEEP greater than 12 cmH2O, oxygen saturation less than 90%, or fraction of inspired oxygen over 60%)
  • Undrained pneumothorax or pneumomediastinum
  • Unstable intracranial pressure (greater than 20 mmHg or mean arterial pressure less than 60)
  • Severe bronchospasm
  • Post cardiothoracic surgery patients
  • Active pulmonary tuberculosis
  • Bronchoesophageal or bronchopleural fistulas
  • Prone position
  • Pregnancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants are assessed for eligibility criteria including medical stability and consent.

Treatment

Duration - Each intervention involves a session with 4 sets of 5 respiratory cycles and 1-minute intervals between sets; crossover study design applies.

Participants will receive two different mechanical insufflation-exsufflation (MI-E) interventions using either an optimized MI-E setting or a standard MI-E setting to assist secretion clearance during invasive mechanical ventilation.

1 to 2 treatment sessions depending on crossover assignment

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

G

Gonzalo Basllesteros Reviriego, Msc

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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Published Research Related To This Trial

Following tracheal intubation, mucus flow is reversed in the semirecumbent position: possible role in the pathogenesis of ventilator-associated pneumonia.

Gianluigi Li Bassi, Alberto Zanella, Massimo Cressoni...

https://pubmed.ncbi.nlm.nih.gov/18176317

The effects of mechanical insufflation-exsufflation on lung function and complications in cardiac surgery patients: a pilot study.

Meng-Fang Wu, Tsai-Yu Wang, Da-Shen Chen...

https://pubmed.ncbi.nlm.nih.gov/34886881

Mechanical Insufflation-exsufflation for the Prevention of Ventilator-associated Pneumonia in Intensive Care Units: A Retrospective Cohort Study.

Ryota Kuroiwa, Yoshihisa Tateishi, Taku Oshima...

https://pubmed.ncbi.nlm.nih.gov/33603304

Ventilator-associated pneumonia or endotracheal tube-associated pneumonia? An approach to the pathogenesis and preventive strategies emphasizing the importance of endotracheal tube.

Ioannis A Pneumatikos, Christos K Dragoumanis, Demosthenes E Bouros

https://pubmed.ncbi.nlm.nih.gov/19212256