Mechanical Ventilation Complication Clinical Trial
Official title:
Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients
Critically ill and intubated patients on mechanical ventilation (IMV) often present retention
of respiratory secretions, increasing the risk of respiratory infections and associated
morbidity. Endotracheal suctioning (ETS) is the main strategy to prevent mucus retention, but
its effects are limited to the first bronchial bifurcation.
Mechanical in-exsufflation devices (MI-E) are a non-invasive chest physiotherapy (CPT)
technique that aims to improve mucus clearance in proximal airways by generating high
expiratory flows and simulating cough. Currently there are no studies that have specifically
assessed the effects of MI-E in critically ill and intubated patients. Thus, the aims of this
study are to evaluate efficacy and safety of MI-E to improve mucus clearance in critically
ill and intubated patients.
Controlled randomized, cross-over, single blind trial conducted at University Hospital of
Bordeaux (France).
Inclusion criteria: Patients (>18 yo) intubated [internal diameter (ID) 7 to 8], sedated
[Richmond Agitation Sedation Scale (RASS) -3 to -5], connected to IMV at least 48 h and
expected IMV of at least 24h.
Exclusion criteria: Lung disease or pulmonary parenchyma damage, respiratory inspired
fraction of oxygen (FiO2) >60% and/or positive end-expiratory pressure (PEEP) > 10
centimetres of water (cmH2O) and/or hemodynamic instability (mean arterial pressure (MAP) <
65 millimetres of mercury (mmHg) although use of vasopressors] , hemofiltered patients
through a central jugular catheter, patients on strict dorsal decubitus by medical
prescription, and high respiratory infectious risk.
Design: All patients will receive CPT followed by ETS twice daily. However, patients will
randomly receive in one of the sessions an additional treatment of MI-E before ETS. MI-E
treatment consists in 4 series of 5 in-expiratory cycles at +/- 40 cmH2O, 3 and 2 sec of
inspiratory-expiratory time and 1 sec pause between cycles.
Variables: Mucus clearance will be assessed through wet volume of suctioned sputum through a
suction catheter connected to a sterile collector container. Pulmonary mechanics will be
measured before, after and 1 h post-intervention through a pneumotachograph (PNT). Peak
expiratory flow (PEF) generated by MI-E will be continuously measured through a PNT.
Hemodynamic measurements will be recorded before, after and 1 h post-intervention.
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