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Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU

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ClinicalTrials.gov Identifier: NCT03316079
Recruitment Status : Unknown
Verified October 2017 by Roberto Martinez Alejos, University Hospital, Bordeaux.
Recruitment status was:  Recruiting
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
Sociedad Española de Neumología y Cirugía Torácica
Information provided by (Responsible Party):
Roberto Martinez Alejos, University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Mucus Retention Mechanical Ventilation Complication Mucus; Plug, Tracheobronchial Other: Chest physiotherapy techniques Device: Mechanical insufflation-exsufflation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients
Actual Study Start Date : March 6, 2015
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2017

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).




Primary Outcome Measures :
  1. Mucus volume retrieved [ Time Frame: Immediately after treatment ]
    respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container


Secondary Outcome Measures :
  1. Pulmonary mechanics [ Time Frame: Immediately before treatment ]
    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).

  2. Pulmonary mechanics [ Time Frame: Immediately before treatment ]
    Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).

  3. Pulmonary mechanics [ Time Frame: Immediately before treatment ]
    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).

  4. Pulmonary mechanics [ Time Frame: Immediately after treatment ]
    Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).

  5. Pulmonary mechanics [ Time Frame: Immediately after treatment ]
    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).

  6. Pulmonary mechanics [ Time Frame: Immediately after treatment ]
    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).

  7. Pulmonary mechanics [ Time Frame: 1 hour after treatment ]
    Pulmonary mechanics will be measured with a pulmonary mechanics monitor connected to endotracheal tube. We will obtain airway resistance (Raw) (cmH2O/l/s).

  8. Pulmonary mechanics [ Time Frame: 1 hour after treatment ]
    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).

  9. Pulmonary mechanics [ Time Frame: 1 hour after treatment ]
    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).

  10. Hemodynamic measurements [ Time Frame: Immediately before treatment ]
    Heart Beat per minute (HB) with continous monitoring

  11. Hemodynamic measurements [ Time Frame: Immediately after treatment ]
    Heart Beat per minute (HB) with continous monitoring

  12. Hemodynamic measurements [ Time Frame: 1 hour after treatment ]
    Heart Beat per minute (HB) with continous monitoring

  13. Hemodynamic measurements [ Time Frame: Immediately before treatment ]
    Blood Pressure in mmHg will be measured with continous monitoring

  14. Hemodynamic measurements [ Time Frame: Immediately after treatment ]
    Blood Pressure in mmHg will be measured with continous monitoring

  15. Hemodynamic measurements [ Time Frame: 1 hour after treatment ]
    Blood Pressure in mmHg will be measured with continous monitoring

  16. Arterial blood gases [ Time Frame: Immediately before treatment ]
    pH (in units) will be obtained from radial artery and blood gases analyzed.

  17. Arterial blood gases [ Time Frame: Immediately after treatment ]
    pH (in units) will be obtained from radial artery and blood gases analyzed.

  18. Arterial blood gases [ Time Frame: 1 hour after treatment ]
    pH (in units) will be obtained from radial artery and blood gases analyzed.

  19. Arterial blood gases [ Time Frame: Immediately before treatment ]
    Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.

  20. Arterial blood gases [ Time Frame: Immediately after treatment ]
    Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.

  21. Arterial blood gases [ Time Frame: 1 hour after treatment ]
    Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.

  22. Arterial blood gases [ Time Frame: Immediately before treatment ]
    Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.

  23. Arterial blood gases [ Time Frame: Immediately after treatment ]
    Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.

  24. Arterial blood gases [ Time Frame: 1 hour after treatment ]
    Partial pressure of carbon dioxide (PCO2; mmHg) will be obtained from radial artery and blood gases analyzed.

  25. Arterial blood gases [ Time Frame: Immediately before treatment ]
    Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.

  26. Arterial blood gases [ Time Frame: Immediately after treatment ]
    Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.

  27. Arterial blood gases [ Time Frame: 1 hour after treatment ]
    Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.

  28. Complications [ Time Frame: Through study completion ]

    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%



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316079


Contacts
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Contact: Roberto Martinez Alejos, Msc 0033 677952556 rober.martinez.alejos@gmail.com
Contact: Joan Daniel Martí Romeu, PhD 0034 627 95 48 27 jd.martibcn@gmail.com

Locations
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France
Medical ICU Recruiting
Bordeaux, France, 33000
Contact: Thomas Reginault, RPT    00 33 616 18 13 40    thomas.reginault@chu-bordeaux.fr   
Sub-Investigator: Xabier Pilar Diaz, Msc         
Vascular ICU. Completed
Bordeaux, France, 33000
Polyvalent ICU. Centre medico-chirurgicale Magellan 2. Recruiting
Pessac, France, 33600
Contact: Roberto Martinez Alejos, Msc    0033 677952556    rober.martinez.alejos@gmail.com   
Sub-Investigator: Alice Quinart, PhD, MD         
Sub-Investigator: Catherine Fleaurau, PhD, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Sociedad Española de Neumología y Cirugía Torácica
Investigators
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Principal Investigator: Roberto Martinez Alejos, Msc University Hospital Bordeaux, France
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roberto Martinez Alejos, RPT, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03316079    
Other Study ID Numbers: DC2015/02
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto Martinez Alejos, University Hospital, Bordeaux:
intensive care
invasive mechanical ventilation
mechanical insufflation-exsufflation
airway mucus clearance
chest physiotherapy
peak expiratory flow
pulmonary mechanics