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NCT Number: NCT03327610

Selecting the Best Ventilator Hyperinflation Settings

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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VC-CMV20

Other

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.

VC-CMV50

Other

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.

PC-CMV1

Other

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.

PC-CMV3

Other

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.

PSV10

Other

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.

PSV25

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centro Universitário Augusto Motta

Other

Collaborators

  • Universidade Federal do Rio de Janeiro

Registry information

Official study title

Selecting the Best Ventilator Hyperinflation Settings Based on Physiologic Markers: Randomized Controlled Study

Acronym: VHI1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2017
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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