Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU
NCT ID: NCT03316079
Last Updated: 2017-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
26 participants
INTERVENTIONAL
2015-03-06
2017-12-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Chest physiotherapy techniques
Manual chest physiotherapy techniques applied
Chest physiotherapy techniques
Respiratory manual CPT
Chest physiotherapy techniques + Mechanical in-exsufflation
Mechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques
Mechanical insufflation-exsufflation
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).
Interventions
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Chest physiotherapy techniques
Respiratory manual CPT
Mechanical insufflation-exsufflation
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).
Eligibility Criteria
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Inclusion Criteria
* Patents endotracheally intubated (tubes between 7mm and 8mm of internal diameter).
* Invasive mechanical ventilation \> 48h
* Invasive mechanical ventilation expected \> 24h
* RASS between -3 and -5
Exclusion Criteria
* Hemofiltered patients through a central jugular catheter.
* Respiratory instability (FiO2) \>60% and/or (PEEP) \> 10cmH2O, and/or hemodynamic instability (MAP) \< 65mmHg although use of vasopressors)\] instability
* Patients on strict dorsal decubitus by medical prescription.
* High risk infection patients (eg: tuberculosis, H1N1) that cannot be disconnected from IMV.
18 Years
90 Years
ALL
No
Sponsors
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Sociedad Española de Neumología y Cirugía Torácica
OTHER
University Hospital, Bordeaux
OTHER
Responsible Party
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Roberto Martinez Alejos
RPT
Principal Investigators
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Roberto Martinez Alejos, Msc
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Locations
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Medical ICU
Bordeaux, , France
Vascular ICU.
Bordeaux, , France
Polyvalent ICU. Centre medico-chirurgicale Magellan 2.
Pessac, , France
Countries
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Central Contacts
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Facility Contacts
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Thomas Reginault, RPT
Role: primary
Roberto Martinez Alejos, Msc
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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DC2015/02
Identifier Type: -
Identifier Source: org_study_id