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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

Tracking Information
First Submitted Date  ICMJE October 3, 2017
First Posted Date  ICMJE October 20, 2017
Last Update Posted Date October 20, 2017
Actual Study Start Date  ICMJE March 6, 2015
Estimated Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
Mucus volume retrieved [ Time Frame: Immediately after treatment ]
respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • Hemodynamic measurements [ Time Frame: Immediately before treatment ]
    Heart Beat per minute (HB) with continous monitoring
  • Hemodynamic measurements [ Time Frame: Immediately after treatment ]
    Heart Beat per minute (HB) with continous monitoring
  • Hemodynamic measurements [ Time Frame: 1 hour after treatment ]
    Heart Beat per minute (HB) with continous monitoring
  • Hemodynamic measurements [ Time Frame: Immediately before treatment ]
    Blood Pressure in mmHg will be measured with continous monitoring
  • Hemodynamic measurements [ Time Frame: Immediately after treatment ]
    Blood Pressure in mmHg will be measured with continous monitoring
  • Hemodynamic measurements [ Time Frame: 1 hour after treatment ]
    Blood Pressure in mmHg will be measured with continous monitoring
  • Arterial blood gases [ Time Frame: Immediately before treatment ]
    pH (in units) will be obtained from radial artery and blood gases analyzed.
  • Arterial blood gases [ Time Frame: Immediately after treatment ]
    pH (in units) will be obtained from radial artery and blood gases analyzed.
  • Arterial blood gases [ Time Frame: 1 hour after treatment ]
    pH (in units) will be obtained from radial artery and blood gases analyzed.
  • Arterial blood gases [ Time Frame: Immediately before treatment ]
    Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
  • Arterial blood gases [ Time Frame: Immediately after treatment ]
    Partial pressure of oxygen (PO2; mmHg) will be obtained from radial artery and blood gases analyzed.
  • 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.
  • 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.
  • 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.
  • 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.
  • Arterial blood gases [ Time Frame: Immediately before treatment ]
    Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
  • Arterial blood gases [ Time Frame: Immediately after treatment ]
    Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
  • Arterial blood gases [ Time Frame: 1 hour after treatment ]
    Peripheral oxygen saturation (SPO2; %) will be obtained from radial artery and blood gases analyzed.
  • 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%
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU
Official Title  ICMJE Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Mucus Retention
  • Mechanical Ventilation Complication
  • Mucus; Plug, Tracheobronchial
Intervention  ICMJE
  • Other: Chest physiotherapy techniques
    Respiratory manual CPT
  • 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).
Study Arms  ICMJE
  • Active Comparator: Chest physiotherapy techniques
    Manual chest physiotherapy techniques applied
    Intervention: Other: Chest physiotherapy techniques
  • Experimental: Chest physiotherapy techniques + Mechanical in-exsufflation
    Mechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques
    Intervention: Device: Mechanical insufflation-exsufflation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03316079
Other Study ID Numbers  ICMJE DC2015/02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Roberto Martinez Alejos, University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Sociedad Española de Neumología y Cirugía Torácica
Investigators  ICMJE
Principal Investigator: Roberto Martinez Alejos, Msc University Hospital Bordeaux, France
PRS Account University Hospital, Bordeaux
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP