Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU

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.

Study Overview

• Status: Unknown
• Conditions: Mechanical Ventilation Complication; Mucus Retention; Mucus; Plug, Tracheobronchial
• Intervention / Treatment: Other: Chest physiotherapy techniques; Device: Mechanical insufflation-exsufflation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • Medical ICU
    • Contact: Thomas Reginault, RPT; Phone Number: 00 33 616 18 13 40; Email: thomas.reginault@chu-bordeaux.fr
    • Sub-Investigator: Xabier Pilar Diaz, Msc
  • Bordeaux, France, 33000
    • Completed
    • Vascular ICU.
  • Pessac, France, 33600
    • Recruiting
    • Polyvalent ICU. Centre medico-chirurgicale Magellan 2.
    • Contact: Roberto Martinez Alejos, Msc; Phone Number: 0033 677952556; Email: rober.martinez.alejos@gmail.com
    • Sub-Investigator: Alice Quinart, PhD, MD
    • Sub-Investigator: Catherine Fleaurau, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chest physiotherapy techniques; Manual chest physiotherapy techniques applied	Other: Chest physiotherapy techniques; Respiratory manual CPT
Experimental: Chest physiotherapy techniques + Mechanical in-exsufflation; Mechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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: 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%	Through study completion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica
• Investigators: Principal Investigator: Roberto Martinez Alejos, Msc, University Hospital Bordeaux, France

Publications and helpful links

General Publications

• 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.
• Martínez-Alejos R, Martí 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: intensive care; invasive mechanical ventilation; mechanical insufflation-exsufflation; airway mucus clearance; chest physiotherapy; peak expiratory flow; pulmonary mechanics
• Other Study ID Numbers: DC2015/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No