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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
Respiratory manual CPT
CPT + MI-E (4 series of 5 inspiratory-expiratory cycles at +/- 40 cmH2O, 3 seconds of inspiratory time, 2 seconds of expiratory time and 1 second pause between cycles).
Medical ICU
Bordeaux, France
RECRUITINGVascular ICU.
Bordeaux, France
COMPLETEDPolyvalent ICU. Centre medico-chirurgicale Magellan 2.
Pessac, France
RECRUITINGMucus volume retrieved
respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container
Time frame: Immediately after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), plateau pressure (Ppl; cmH20), tidal volume (Vt; ml). We will combine PIP, Ppl and Vt to obtain static compliance (Cst) (ml/cmH2O).
Time frame: Immediately before treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).
Time frame: Immediately before treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), positive expiratory pressure (PEEP; cmH20), and peak inspiratory flow (PIF; l/s). We will combine PIP, PEEP and PIF to obtain respiratory system resistance (Rsr) (cmH2O/l/s).
Time frame: Immediately before treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).
Time frame: Immediately after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), plateau pressure (Ppl; cmH20), tidal volume (Vt; ml). We will combine PIP, Ppl and Vt to obtain static compliance (Cst) (ml/cmH2O).
Time frame: Immediately after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), positive expiratory pressure (PEEP; cmH20), and peak inspiratory flow (PIF; l/s). We will combine PIP, PEEP and PIF to obtain respiratory system resistance (Rsr) (cmH2O/l/s).
Time frame: Immediately after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).
Time frame: 1 hour after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), plateau pressure (Ppl; cmH20), tidal volume (Vt; ml). We will combine PIP, Ppl and Vt to obtain static compliance (Cst) (ml/cmH2O).
Time frame: 1 hour after treatment
Pulmonary mechanics
Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain positive inspiratory pressure (PIP; cmH20), positive expiratory pressure (PEEP; cmH20), and peak inspiratory flow (PIF; l/s). We will combine PIP, PEEP and PIF to obtain respiratory system resistance (Rsr) (cmH2O/l/s).
Time frame: 1 hour after treatment
Hemodynamic measurements
Heart Beat per minute (HB) with continous monitoring
Time frame: Immediately before treatment
Hemodynamic measurements
Heart Beat per minute (HB) with continous monitoring
Time frame: Immediately after treatment
Hemodynamic measurements
Heart Beat per minute (HB) with continous monitoring
Time frame: 1 hour after treatment
Hemodynamic measurements
Blood Pressure in mmHg will be measured with continous monitoring
Time frame: Immediately before treatment
Hemodynamic measurements
Blood Pressure in mmHg will be measured with continous monitoring
Time frame: Immediately after treatment
Hemodynamic measurements
Blood Pressure in mmHg will be measured with continous monitoring
Time frame: 1 hour after treatment
Arterial blood gases
pH (in units) will be obtained from radial artery and blood gases analyzed.
Time frame: Immediately before treatment
Arterial blood gases
pH (in units) will be obtained from radial artery and blood gases analyzed.
Time frame: Immediately after treatment
Arterial blood gases
pH (in units) will be obtained from radial artery and blood gases analyzed.
Time frame: 1 hour after treatment
Arterial blood gases
Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Time frame: Immediately before treatment
Arterial blood gases
Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Time frame: Immediately after treatment
Arterial blood gases
Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Time frame: 1 hour after treatment
Arterial blood gases
Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Time frame: Immediately before treatment
Arterial blood gases
Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Time frame: Immediately after treatment
Arterial blood gases
Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.
Time frame: 1 hour after treatment
Arterial blood gases
Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
Time frame: Immediately before treatment
Arterial blood gases
Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
Time frame: Immediately after treatment
Arterial blood gases
Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
Time frame: 1 hour after treatment
Complications
We will asess the following adverse events that could happen while we will applying protocol: * Mean arterial pressure lower than 15% from baseline * Systolic blood pressure higher or lower than 15% from baseline * Diastolic blood pressure higher or lower than 15% from baseline * Heart rate higher or lower than 20% from baseline * Oxygen saturation \< 85%
Time frame: Through study completion
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