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Selecting the Best Ventilator Hyperinflation Settings (VHI1)

Primary Purpose

Respiratory Failure, Respiration Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VC-CMV20
VC-CMV50
PC-CMV1
PC-CMV3
PSV10
PSV25
Sponsored by
Centro Universitário Augusto Motta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Respiratory Therapy, Positive Pressure Respiration, Physical Therapy Modalities

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients under mechanical ventilation for more than 48h

Exclusion Criteria:

  • mucus hypersecretion (defined as the need for suctioning < 2-h intervals),
  • absence of respiratory drive,
  • atelectasis,
  • severe bronchospasm,
  • positive end expiratory pressure > 10cmH2O,
  • PaO2-FiO2 relationship < 150,
  • mean arterial pressure < 60mmHg,
  • inotrope requirement equivalent to >15 ml/h total of adrenaline and noradrenalin,
  • intracranial pressure > 20mmHg

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    BASELINE

    VC-CMV20

    VC-CMV50

    PC-CMV1

    PC-CMV3

    PSV10

    PSV25

    Arm Description

    The subjects were kept in their current ventilatory mode.

    Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 20Lpm.

    Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 50Lpm.

    Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 1 second.

    Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 3 seconds.

    Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 10% of peak inspiratory flow.

    Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 25% of peak inspiratory flow.

    Outcomes

    Primary Outcome Measures

    Peak inspiratory to expiratory flow ratio
    Dichotomous variable, defined as achieving a peak inspiratory flow rate (PIFR) less than 90% of the peak expiratory flow rate (PEFR)
    Peak expiratory flow higher than 40 Lpm
    Dichotomous variable, defined as achieving a PEFR higher than 40 l/min
    Difference between peak inspiratory and expiratory flows.
    Dichotomous variable, defined as achieving a difference higher than 17Lpm.
    Pulmonary expansion
    Percentage of tidal volume above the normal tidal volume (estimated as 6mL/kg).

    Secondary Outcome Measures

    Mean arterial pressure
    Mean arterial pressure verified using the multi-parameter monitor.
    Heart Rate
    Heart rate verified using the multi-parameter monitor.

    Full Information

    First Posted
    October 27, 2017
    Last Updated
    October 27, 2017
    Sponsor
    Centro Universitário Augusto Motta
    Collaborators
    Universidade Federal do Rio de Janeiro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03327610
    Brief Title
    Selecting the Best Ventilator Hyperinflation Settings
    Acronym
    VHI1
    Official Title
    Selecting the Best Ventilator Hyperinflation Settings Based on Physiologic Markers: Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    August 2017 (Actual)
    Study Completion Date
    August 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centro Universitário Augusto Motta
    Collaborators
    Universidade Federal do Rio de Janeiro

    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
    Ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, there are no recommendations on the best ventilator settings to perform the technique. Thus, the aim of this study was to compare six modes of VHI, concerning physiological markers of efficacy and safety criteria, in order to support the optimal VHI settings selection for mechanically ventilated patients. In a randomized, controlled and crossover study, 30 mechanically ventilated patients underwent 6 modes of ventilator hyperinflation. The maximum expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow patterns), overdistension (alveolar pressure), asynchronies and hemodynamic variables (mean arterial pressure and heart rate) were assessed during the interventions.
    Detailed Description
    Background: Ventilator Hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, there are no recommendations on the best ventilator settings to perform the technique. Thus, the aim of this study was to compare six modes of VHI, concerning physiological markers of efficacy and safety criteria, in order to support the optimal VHI settings selection for mechanically ventilated patients. Methods: In a crossover study, every included mechanically ventilated patient underwent six modes of VHI in a randomized order: Volume Control Continuous Mandatory Ventilation (VC-CMV) with inspiratory flow = 20Lpm (VC-CMV20), VC-CMV with inspiratory flow = 50Lpm (VC-CMV50), Pressure Control Continuous Mandatory Ventilation (PC-CMV) with inspiratory time = 1s. (PC-CMV1), PC-CMV with inspiratory time = 3s. (PC-CMV3), Pressure Support Ventilation (PSV) with cycling off = 10% of peak inspiratory flow (PSV10), and PSV with cycling off = 25% of peak inspiratory flow (PSV25). The maximum expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow patterns), over-distension (alveolar pressure), asynchronies and hemodynamic variables (mean arterial pressure and heart rate) were assessed during the interventions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Failure, Respiration Disorders
    Keywords
    Respiratory Therapy, Positive Pressure Respiration, Physical Therapy Modalities

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BASELINE
    Arm Type
    No Intervention
    Arm Description
    The subjects were kept in their current ventilatory mode.
    Arm Title
    VC-CMV20
    Arm Type
    Experimental
    Arm Description
    Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 20Lpm.
    Arm Title
    VC-CMV50
    Arm Type
    Experimental
    Arm Description
    Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 50Lpm.
    Arm Title
    PC-CMV1
    Arm Type
    Experimental
    Arm Description
    Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 1 second.
    Arm Title
    PC-CMV3
    Arm Type
    Experimental
    Arm Description
    Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 3 seconds.
    Arm Title
    PSV10
    Arm Type
    Experimental
    Arm Description
    Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 10% of peak inspiratory flow.
    Arm Title
    PSV25
    Arm Type
    Experimental
    Arm Description
    Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 25% of peak inspiratory flow.
    Intervention Type
    Other
    Intervention Name(s)
    VC-CMV20
    Intervention Description
    Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow was set at 20Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
    Intervention Type
    Other
    Intervention Name(s)
    VC-CMV50
    Intervention Description
    Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow was set at 50Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
    Intervention Type
    Other
    Intervention Name(s)
    PC-CMV1
    Intervention Description
    Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1). The inspiratory time was set at 1 second and the pressure control was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
    Intervention Type
    Other
    Intervention Name(s)
    PC-CMV3
    Intervention Description
    Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1). The inspiratory time was set at 3 seconds and the pressure control was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
    Intervention Type
    Other
    Intervention Name(s)
    PSV10
    Intervention Description
    Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV). The cycling off was set at 10% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
    Intervention Type
    Other
    Intervention Name(s)
    PSV25
    Intervention Description
    Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV). The cycling off was set at 25% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
    Primary Outcome Measure Information:
    Title
    Peak inspiratory to expiratory flow ratio
    Description
    Dichotomous variable, defined as achieving a peak inspiratory flow rate (PIFR) less than 90% of the peak expiratory flow rate (PEFR)
    Time Frame
    Ten minutes after the onset of intervention.
    Title
    Peak expiratory flow higher than 40 Lpm
    Description
    Dichotomous variable, defined as achieving a PEFR higher than 40 l/min
    Time Frame
    Ten minutes after the onset of intervention.
    Title
    Difference between peak inspiratory and expiratory flows.
    Description
    Dichotomous variable, defined as achieving a difference higher than 17Lpm.
    Time Frame
    Ten minutes after the onset of intervention.
    Title
    Pulmonary expansion
    Description
    Percentage of tidal volume above the normal tidal volume (estimated as 6mL/kg).
    Time Frame
    Ten minutes after the onset of intervention.
    Secondary Outcome Measure Information:
    Title
    Mean arterial pressure
    Description
    Mean arterial pressure verified using the multi-parameter monitor.
    Time Frame
    Ten minutes after the onset of intervention.
    Title
    Heart Rate
    Description
    Heart rate verified using the multi-parameter monitor.
    Time Frame
    Ten minutes after the onset of intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients under mechanical ventilation for more than 48h Exclusion Criteria: mucus hypersecretion (defined as the need for suctioning < 2-h intervals), absence of respiratory drive, atelectasis, severe bronchospasm, positive end expiratory pressure > 10cmH2O, PaO2-FiO2 relationship < 150, mean arterial pressure < 60mmHg, inotrope requirement equivalent to >15 ml/h total of adrenaline and noradrenalin, intracranial pressure > 20mmHg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    FERNANDO S GUIMARAES, PhD
    Organizational Affiliation
    Centro Universitário Augusto Motta
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12109234
    Citation
    Berney S, Denehy L. A comparison of the effects of manual and ventilator hyperinflation on static lung compliance and sputum production in intubated and ventilated intensive care patients. Physiother Res Int. 2002;7(2):100-8. doi: 10.1002/pri.246.
    Results Reference
    background
    PubMed Identifier
    19929767
    Citation
    Lemes DA, Zin WA, Guimaraes FS. Hyperinflation using pressure support ventilation improves secretion clearance and respiratory mechanics in ventilated patients with pulmonary infection: a randomised crossover trial. Aust J Physiother. 2009;55(4):249-54. doi: 10.1016/s0004-9514(09)70004-2.
    Results Reference
    background
    PubMed Identifier
    25579293
    Citation
    Thomas PJ. The effect of mechanical ventilator settings during ventilator hyperinflation techniques: a bench-top analysis. Anaesth Intensive Care. 2015 Jan;43(1):81-7. doi: 10.1177/0310057X1504300112.
    Results Reference
    background
    PubMed Identifier
    21682986
    Citation
    Ntoumenopoulos G, Shannon H, Main E. Do commonly used ventilator settings for mechanically ventilated adults have the potential to embed secretions or promote clearance? Respir Care. 2011 Dec;56(12):1887-92. doi: 10.4187/respcare.01229. Epub 2011 Jun 17.
    Results Reference
    background
    PubMed Identifier
    25453540
    Citation
    Anderson A, Alexanders J, Sinani C, Hayes S, Fogarty M. Effects of ventilator vs manual hyperinflation in adults receiving mechanical ventilation: a systematic review of randomised clinical trials. Physiotherapy. 2015 Jun;101(2):103-10. doi: 10.1016/j.physio.2014.07.006. Epub 2014 Oct 6.
    Results Reference
    background
    PubMed Identifier
    27235313
    Citation
    Davies JD, Senussi MH, Mireles-Cabodevila E. Should A Tidal Volume of 6 mL/kg Be Used in All Patients? Respir Care. 2016 Jun;61(6):774-90. doi: 10.4187/respcare.04651.
    Results Reference
    background
    PubMed Identifier
    21235839
    Citation
    de Wit M. Monitoring of patient-ventilator interaction at the bedside. Respir Care. 2011 Jan;56(1):61-72. doi: 10.4187/respcare.01077.
    Results Reference
    background
    Links:
    URL
    http://www.researcherid.com/ProfileView.action?returnCode=ROUTER.Unauthorized&Init=Yes&SrcApp=CR&queryString=KG0UuZjN5WkrS6qTMqySbml%252FKME%252FypfZgkjPia93VtU%253D
    Description
    ResearcherID profile (Chair researcher)

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