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Effects of Secretion Removal in Ventilated Patients

Primary Purpose

Acute Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
in-exufflator technique
percussion technique
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

consecutive ventilated and intubated patients

  1. age> 18 yrs
  2. Sign inform consent
  3. clinical indication for secretion removal from the endotracheal tube

    -

    Exclusion Criteria:

    • tracheotomy
    • bullous emphysema
    • pneumothorax

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    in-exufflator and percussion technique

    Arm Description

    assess the physiological effects, of a "common" daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique

    Outcomes

    Primary Outcome Measures

    Changes in passive respiratory mechanics
    RESPIRATORY MECHANICS is monitored using the end-expiratory and end inspiratory technique, obtained pressing the hold command on the ventilator

    Secondary Outcome Measures

    changes in arterial blood gases
    changes in arterial partial oxygen tension and in arterial partial carbon dioxide tension obtained with a puncture of the radial artery

    Full Information

    First Posted
    November 23, 2018
    Last Updated
    November 27, 2018
    Sponsor
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Collaborators
    Fondazione Salvatore Maugeri
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03758547
    Brief Title
    Effects of Secretion Removal in Ventilated Patients
    Official Title
    Physiological Effects of the Application of Secretion Removal Device in Invasively Ventilated Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    June 30, 2019 (Anticipated)
    Study Completion Date
    June 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Collaborators
    Fondazione Salvatore Maugeri

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this study the investigators will assess the effects of secretion removal on "noninvasive" respiratory mechanics, in deeply sedated mechanically ventilated patients All the mechanically ventilated patients will be submitted to the recording of compliance and resistance at baseline (time0), immediately after the application of 10 cycles alternating 30 cmH20 during expiration and -30 cmH20 during exhalation (time1). Afterward the patients will undergo an additional trail using the so called "percussion" technique, to assess any synergic effect of this procedure (time2)
    Detailed Description
    In this observational study, the investigators will assess the effects of two secretion removal techniques on passive respiratory mechanics, in patients undergoing invasive mechanical ventilation. Consecutive patients will undergo 3 sequential assessments at time0 (baseline), at time1 after the application of of 10 cycles alternating 30 cmH20 during expiration and -30 cmH20 during exhalation and finally after a 20 sec application of a "percussion technique". Protocol: The patients will be ventilated without PEEP and sedated with a benzodiazepine infusion to produce complete relaxation and adaptation to the ventilator, as assessed by the complete absence of spontaneous efforts, so that there was no change in inspiratory flow rate, tidal volume, or respiratory rate during the three measurement periods. Airway pressure (Paw) and flow (V) will be measured continuously throughout the respiratory cycle with the transducer and expiratory tidal volume will obtained by electrical integration of the flow signal. Arterial blood gas specimens will be withdrawn from the radial artery and analyzed with a blood gas analyzer The patients will be studied in the semi recumbent position. After baseline measurements of respiratory mechanics will recorded under control conditions. Direct measurement of PEEPi will be obtained using the following method: After several breaths under controlled mechanical ventilation, and with the patient relaxed, the airway opening is occluded at the end of a tidal expiration, using the end-expiratory hold button incorporated in the ventilator. The occlusion will be then released for the mechanical lung inflation, and after a few breaths the airway opening will be again occluded at the end of the inflation, using the end-inspiratory hold button of the ventilator. The static compliance of the total respiratory system (Cst rs) will be corrected for the compliance of the ventilator tubing and the gas compression (0.8 ml/cm H20 2). The end-inspiratory occlusion technique also allows determination of the inspiratory resistive properties of the respiratory system, named R,rs min and R,rsmax, that means the minimal respiratory resistances (those due mainly to the airways) and maximal respiratory resistances (those mainly due to stress relaxation and Pendelluft)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    baseline (time0) application of 10 cycles of positive inspiratory and negative expiratory pressures (time1) application of percussion (time2)
    Masking
    None (Open Label)
    Masking Description
    patients deeply sedated and therefore not conscious
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    in-exufflator and percussion technique
    Arm Type
    Experimental
    Arm Description
    assess the physiological effects, of a "common" daily practice of secretion removal in intubated patients, that are: in-exufflator technique and percussion technique
    Intervention Type
    Device
    Intervention Name(s)
    in-exufflator technique
    Intervention Description
    application through a device of 10 cycles using positive pressure (30 cmH20) during inspiration and negative pressure (-30 cmH20) during exhalation
    Intervention Type
    Device
    Intervention Name(s)
    percussion technique
    Intervention Description
    sliding venturi system (phasitron), powered by compressed gas that can be changed from 0.8 up to 3.5 bar and that generates the oscillations in the range of 80-650 cycles/min
    Primary Outcome Measure Information:
    Title
    Changes in passive respiratory mechanics
    Description
    RESPIRATORY MECHANICS is monitored using the end-expiratory and end inspiratory technique, obtained pressing the hold command on the ventilator
    Time Frame
    immediate
    Secondary Outcome Measure Information:
    Title
    changes in arterial blood gases
    Description
    changes in arterial partial oxygen tension and in arterial partial carbon dioxide tension obtained with a puncture of the radial artery
    Time Frame
    immediate

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: consecutive ventilated and intubated patients age> 18 yrs Sign inform consent clinical indication for secretion removal from the endotracheal tube - Exclusion Criteria: tracheotomy bullous emphysema pneumothorax

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    not allow to release individual data of the patients

    Learn more about this trial

    Effects of Secretion Removal in Ventilated Patients

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