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| Name | Class |
|---|---|
| Sociedad Española de NeumologÃa y CirugÃa Torácica | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest physiotherapy techniques | Active Comparator | Manual chest physiotherapy techniques applied |
|
| Chest physiotherapy techniques + Mechanical in-exsufflation | Experimental | Mechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest physiotherapy techniques | Other | Respiratory manual CPT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mucus volume retrieved | respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container | Immediately after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediately before treatment |
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Inclusion criteria :
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Martinez Alejos, Msc | Contact | 0033 677952556 | rober.martinez.alejos@gmail.com | |
| Joan Daniel Martà Romeu, PhD | Contact | 0034 627 95 48 27 | jd.martibcn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Martinez Alejos, Msc | University Hospital Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical ICU | Recruiting | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8275739 | Result | Konrad F, Schreiber T, Brecht-Kraus D, Georgieff M. Mucociliary transport in ICU patients. Chest. 1994 Jan;105(1):237-41. doi: 10.1378/chest.105.1.237. | |
| 20507660 | Result | American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64. |
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| Mechanical insufflation-exsufflation |
| Device |
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). |
|
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 1 hour after treatment |
| Hemodynamic measurements | Heart Beat per minute (HB) with continous monitoring | Immediately before treatment |
| Hemodynamic measurements | Heart Beat per minute (HB) with continous monitoring | Immediately after treatment |
| Hemodynamic measurements | Heart Beat per minute (HB) with continous monitoring | 1 hour after treatment |
| Hemodynamic measurements | Blood Pressure in mmHg will be measured with continous monitoring | Immediately before treatment |
| Hemodynamic measurements | Blood Pressure in mmHg will be measured with continous monitoring | Immediately after treatment |
| Hemodynamic measurements | Blood Pressure in mmHg will be measured with continous monitoring | 1 hour after treatment |
| Arterial blood gases | pH (in units) will be obtained from radial artery and blood gases analyzed. | Immediately before treatment |
| Arterial blood gases | pH (in units) will be obtained from radial artery and blood gases analyzed. | Immediately after treatment |
| Arterial blood gases | pH (in units) will be obtained from radial artery and blood gases analyzed. | 1 hour after treatment |
| Arterial blood gases | Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed. | Immediately before treatment |
| Arterial blood gases | Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed. | Immediately after treatment |
| Arterial blood gases | Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed. | 1 hour after treatment |
| Arterial blood gases | Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed. | Immediately before treatment |
| Arterial blood gases | Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed. | Immediately after treatment |
| Arterial blood gases | Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed. | 1 hour after treatment |
| Arterial blood gases | Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed. | Immediately before treatment |
| Arterial blood gases | Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed. | Immediately after treatment |
| Arterial blood gases | Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed. | 1 hour after treatment |
| Complications | We will asess the following adverse events that could happen while we will applying protocol:
| Through study completion |
| Vascular ICU. | Completed | Bordeaux | 33000 | France |
| Polyvalent ICU. Centre medico-chirurgicale Magellan 2. | Recruiting | Pessac | 33600 | France |
|
| 18283429 | Result | Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19. |
| 21801577 | Result | Guerin C, Bourdin G, Leray V, Delannoy B, Bayle F, Germain M, Richard JC. Performance of the coughassist insufflation-exsufflation device in the presence of an endotracheal tube or tracheostomy tube: a bench study. Respir Care. 2011 Aug;56(8):1108-14. doi: 10.4187/respcare.01121. |
| 12172066 | Result | Gomez-Merino E, Sancho J, Marin J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83. doi: 10.1097/00002060-200208000-00004. |
| 34103385 | Derived | Martinez-Alejos R, Marti JD, Li Bassi G, Gonzalez-Anton D, Pilar-Diaz X, Reginault T, Wibart P, Ntoumenopoulos G, Tronstad O, Gabarrus A, Quinart A, Torres A. Effects of Mechanical Insufflation-Exsufflation on Sputum Volume in Mechanically Ventilated Critically Ill Subjects. Respir Care. 2021 Sep;66(9):1371-1379. doi: 10.4187/respcare.08641. Epub 2021 Jun 8. |