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Trial record 30 of 279 for:    Best Disease

Selecting the Best Ventilator Hyperinflation Settings (VHI1)

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ClinicalTrials.gov Identifier: NCT03327610
Recruitment Status : Completed
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Universidade Federal do Rio de Janeiro
Information provided by (Responsible Party):
Fernando Silva Guimaraes, Centro Universitário Augusto Motta

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Respiration Disorders Other: VC-CMV20 Other: VC-CMV50 Other: PC-CMV1 Other: PC-CMV3 Other: PSV10 Other: PSV25 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selecting the Best Ventilator Hyperinflation Settings Based on Physiologic Markers: Randomized Controlled Study
Actual Study Start Date : July 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
No Intervention: BASELINE
The subjects were kept in their current ventilatory mode.
Experimental: VC-CMV20
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 20Lpm.
Other: VC-CMV20
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.

Experimental: VC-CMV50
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 50Lpm.
Other: VC-CMV50
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.

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

Experimental: PC-CMV3
Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 3 seconds.
Other: PC-CMV3
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.

Experimental: PSV10
Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 10% of peak inspiratory flow.
Other: PSV10
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.

Experimental: PSV25
Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 25% of peak inspiratory flow.
Other: PSV25
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 Measures :
  1. Peak inspiratory to expiratory flow ratio [ Time Frame: Ten minutes after the onset of intervention. ]
    Dichotomous variable, defined as achieving a peak inspiratory flow rate (PIFR) less than 90% of the peak expiratory flow rate (PEFR)

  2. Peak expiratory flow higher than 40 Lpm [ Time Frame: Ten minutes after the onset of intervention. ]
    Dichotomous variable, defined as achieving a PEFR higher than 40 l/min

  3. Difference between peak inspiratory and expiratory flows. [ Time Frame: Ten minutes after the onset of intervention. ]
    Dichotomous variable, defined as achieving a difference higher than 17Lpm.

  4. Pulmonary expansion [ Time Frame: Ten minutes after the onset of intervention. ]
    Percentage of tidal volume above the normal tidal volume (estimated as 6mL/kg).


Secondary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: Ten minutes after the onset of intervention. ]
    Mean arterial pressure verified using the multi-parameter monitor.

  2. Heart Rate [ Time Frame: Ten minutes after the onset of intervention. ]
    Heart rate verified using the multi-parameter monitor.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03327610


Sponsors and Collaborators
Centro Universitário Augusto Motta
Universidade Federal do Rio de Janeiro
Investigators
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Study Chair: FERNANDO S GUIMARAES, PhD Centro Universitário Augusto Motta

Additional Information:
Publications:

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Responsible Party: Fernando Silva Guimaraes, Associate Professor, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT03327610     History of Changes
Other Study ID Numbers: VHI1
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Fernando Silva Guimaraes, Centro Universitário Augusto Motta:
Respiratory Therapy
Positive Pressure Respiration
Physical Therapy Modalities

Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases