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Completed

NCT Number: NCT03557645

Ventilator Hyperinflation and Hemodynamics

Ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, the literature is scarce concerning its safety and adverse effects. Thus, the aim of this study is to compare the hemodynamic repercussions of VHI in volume-controlled mode. In a randomized, controlled and crossover design, 24 mechanically ventilated patients will undergo 2 modes of ventilator hyperinflation (with and without an inspiratory pause) and a control intervention. Cardiac output, cardiac index, mean arterial pressure, pulmonary vascular resistance, systolic volume and other hemodynamic variables will be recorded during the interventions.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Santa Martha

Niterói, Rio de Janeiro, 24241-002, Brazil

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, the literature is scarce concerning its safety and adverse effects. Thus, the aim of this study is to compare the hemodynamic repercussions of VHI in volume-controlled mode.

Methods: in a randomized, controlled and crossover design, 24 mechanically ventilated patients will undergo 2 modes of ventilator hyperinflation (with and without an inspiratory pause of 2 seconds) and a control intervention. For the VHI interventions, the inspiratory flow will be set at 20 Lpm, and tidal volume will be increased until a peak pressure of 40cmH2O is achieved. During the control intervention, the patients will remain in volume-control ventilation with an inspiratory flow = 60Lpm and tidal volume = 6mL/IBW. The interval between interventions (washout) will be of 10 minutes or more, according to the time needed to recover the cardiac index to baseline values (maximum difference of 10%). Cardiac output, cardiac index, mean arterial pressure, pulmonary vascular resistance, systolic volume and other hemodynamic variables will be recorded during the interventions by using impedance cardiography.

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

Baseline Mechanical Ventilation

Device

The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV).

VHI With Inspiratory Pause

Device

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

VHI Without Inspiratory Pause

Device

Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) without an inspiratory pause.

Primary outcomes

  1. Change in Cardiac Output

    Time frame: Baseline (before) and 10 minutes after the onset of VHI modesBasel

    Estimation of cardiac output variation using thoracic bioimpedance

Secondary outcomes

  1. Change in Cardiac Index

    Time frame: Baseline (before) and 10 minutes after the onset of VHI modes

    Estimation of cardiac index variation using thoracic bioimpedance

  2. Change in Vascular pulmonary resistance

    Time frame: Baseline (before) and 10 minutes after the onset of VHI modes

    Estimation of vascular pulmonary resistance variation using thoracic bioimpedance

  3. Change in Systolic Volume

    Time frame: Baseline (before) and 10 minutes after the onset of VHI modes

    Estimation of systolic volume variation using thoracic bioimpedance

  4. Change in Mean Arterial Pressure

    Time frame: Baseline (before) and 10 minutes after the onset of VHI modes

    Recording of mean arterial pressure variation using an automatic noninvasive device

  5. Change in Cardiac Output II

    Time frame: Baseline (before) and 5 minutes after the end of VHI modes

    Estimation of cardiac output variation using thoracic bioimpedance

  6. Change in Cardiac Index II

    Time frame: Baseline (before) and 5 minutes after the end of VHI modes

    Estimation of cardiac index variation using thoracic bioimpedance

  7. Change in Vascular pulmonary resistance II

    Time frame: Baseline (before) and 5 minutes after the end of VHI modes

    Estimation of vascular pulmonary resistance variation using thoracic bioimpedance

  8. Change in Systolic Volume II

    Time frame: Baseline (before) and 5 minutes after the end of VHI modes

    Estimation of systolic volume variation using thoracic bioimpedance

  9. Change in Mean Arterial Pressure II

    Time frame: Baseline (before) and 5 minutes after the end of VHI modes

    Recording of mean arterial pressure variation using an automatic noninvasive device

Sponsors and collaborators

Lead sponsor

Centro Universitário Augusto Motta

Other

Collaborators

  • Universidade Federal do Rio de Janeiro

Registry information

Official study title

Hemodynamic Repercussions of Ventilator Hyperinflation Using Volume-controlled Ventilation: a Randomized Controlled Trial

Acronym: VHI-HD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Aug 14, 2020

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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