Clinical trial NCT03316079: Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU
Official title: Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mucus Retention
Mechanical Ventilation Complication
Mucus; Plug, Tracheobronchial
Keywords: intensive care
invasive mechanical ventilation
mechanical insufflation-exsufflation
airway mucus clearance
chest physiotherapy
peak expiratory flow
pulmonary mechanics
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2017-10-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria :

* Patients over 18 years old.
* 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 :

* Lung disease with pulmonary parenchyma injury or diseases where mechanical insufflation-exsufflation use is not recommended (eg: emphysema, pneumothorax, pneumomediastinum, hemoptyses, airway instability, acute barotrauma).
* 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.

Primary outcomes:
measure: Mucus volume retrieved
timeFrame: Immediately after treatment
Secondary outcomes:
measure: Pulmonary mechanics
timeFrame: Immediately before treatment
measure: Pulmonary mechanics
timeFrame: Immediately before treatment
measure: Pulmonary mechanics
timeFrame: Immediately before treatment
measure: Pulmonary mechanics
timeFrame: Immediately after treatment
measure: Pulmonary mechanics
timeFrame: Immediately after treatment
measure: Pulmonary mechanics
timeFrame: Immediately after treatment
measure: Pulmonary mechanics
timeFrame: 1 hour after treatment
measure: Pulmonary mechanics
timeFrame: 1 hour after treatment
measure: Pulmonary mechanics
timeFrame: 1 hour after treatment
measure: Hemodynamic measurements
timeFrame: Immediately before treatment
measure: Hemodynamic measurements
timeFrame: Immediately after treatment
measure: Hemodynamic measurements
timeFrame: 1 hour after treatment
measure: Hemodynamic measurements
timeFrame: Immediately before treatment
measure: Hemodynamic measurements
timeFrame: Immediately after treatment
measure: Hemodynamic measurements
timeFrame: 1 hour after treatment
measure: Arterial blood gases
timeFrame: Immediately before treatment
measure: Arterial blood gases
timeFrame: Immediately after treatment
measure: Arterial blood gases
timeFrame: 1 hour after treatment
measure: Arterial blood gases
timeFrame: Immediately before treatment
measure: Arterial blood gases
timeFrame: Immediately after treatment
measure: Arterial blood gases
timeFrame: 1 hour after treatment
measure: Arterial blood gases
timeFrame: Immediately before treatment
measure: Arterial blood gases
timeFrame: Immediately after treatment
measure: Arterial blood gases
timeFrame: 1 hour after treatment
measure: Arterial blood gases
timeFrame: Immediately before treatment
measure: Arterial blood gases
timeFrame: Immediately after treatment
measure: Arterial blood gases
timeFrame: 1 hour after treatment
measure: Complications
timeFrame: Through study completion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Medical ICU
city: Bordeaux
country: France
facility: Vascular ICU.
city: Pessac
country: France
facility: Polyvalent ICU. Centre medico-chirurgicale Magellan 2.
Study officials:
affiliation: University Hospital Bordeaux, France
name: Roberto Martinez Alejos, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.