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Ventilator Hyperinflation and Manual Rib Cage Compression

Primary Purpose

Pulmonary Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Expiratory Rib Cage Compression
Compression + Ventilator Hyperinflation
Sponsored by
Brazilian Institute of Higher Education of Censa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Atelectasis focused on measuring Ventilator Hyperinflation, Expiratory Rib Cage Compression, Physical Therapy, Mechanical Ventilation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients under mechanical ventilation
  • diagnosis of pulmonary infection
  • hypersecretive

Exclusion Criteria:

  • haemodynamic instability (heart rate > 130 bpm and mean arterial pressure < 60 mmHg)
  • acute bronchospasm
  • acute respiratory distress syndrome
  • untreated pneumothorax

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Expiratory Rib Cage Compression

    Compression + Ventilator Hyperinflation

    Arm Description

    Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.

    Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same.

    Outcomes

    Primary Outcome Measures

    Static compliance of respiratory system
    Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.
    Total Resistance of respiratory system
    The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.
    Airway Resistance
    The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.
    Peak expiratory flow
    The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 6, 2018
    Last Updated
    August 9, 2018
    Sponsor
    Brazilian Institute of Higher Education of Censa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03630484
    Brief Title
    Ventilator Hyperinflation and Manual Rib Cage Compression
    Official Title
    Comparison Between Ventilator Hyperinflation and Manual Rib Cage Compression: Randomized Crossover Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 28, 2014 (Actual)
    Primary Completion Date
    December 5, 2014 (Actual)
    Study Completion Date
    July 11, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brazilian Institute of Higher Education of Censa

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a randomized crossover trial to evaluate the effects of thoracic compression applied alone or in association with hyperinflation maneuver with the ventilator. In addition, the mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated.
    Detailed Description
    Ventilator hyperinflation is widely used in hypersecretive patients. It consists of increasing alveolar ventilation by facilitating the coughing mechanism so that the secretions of the peripheral airways are mobilized into the central airways so that they can be removed by tracheal aspiration or cough. Thoracic compression consists of manually compressing the rib cage during expiration, in order to increase expiratory flow, mobilize and remove pulmonary secretions. A randomized crossover clinical trial was performed with 30 patients submitted to isolated compression or associated with ventilator hyperinflation, with a 6 hour interval. Patients were evaluated through compliance and resistance of the respiratory system.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Atelectasis
    Keywords
    Ventilator Hyperinflation, Expiratory Rib Cage Compression, Physical Therapy, Mechanical Ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Expiratory Rib Cage Compression
    Arm Type
    Active Comparator
    Arm Description
    Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.
    Arm Title
    Compression + Ventilator Hyperinflation
    Arm Type
    Active Comparator
    Arm Description
    Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same.
    Intervention Type
    Other
    Intervention Name(s)
    Expiratory Rib Cage Compression
    Intervention Description
    Compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.
    Intervention Type
    Other
    Intervention Name(s)
    Compression + Ventilator Hyperinflation
    Intervention Description
    Mechanical ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same. In Expiratory Rib Cage Compression associated with ventilator hyperinflation, thoracic compression maneuver was performed at the end of inspiration, at the exact moment of cycling.
    Primary Outcome Measure Information:
    Title
    Static compliance of respiratory system
    Description
    Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.
    Time Frame
    Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
    Title
    Total Resistance of respiratory system
    Description
    The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.
    Time Frame
    Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
    Title
    Airway Resistance
    Description
    The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.
    Time Frame
    Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
    Title
    Peak expiratory flow
    Description
    The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.
    Time Frame
    Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients under mechanical ventilation diagnosis of pulmonary infection hypersecretive Exclusion Criteria: haemodynamic instability (heart rate > 130 bpm and mean arterial pressure < 60 mmHg) acute bronchospasm acute respiratory distress syndrome untreated pneumothorax
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    LUCIANO M CHICAYBAN, MSc
    Organizational Affiliation
    Brazilian Institute of Higher Education of Censa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Ventilator Hyperinflation and Manual Rib Cage Compression

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