Hospital Santa Martha
Niterói, Rio de Janeiro, 24241-002, Brazil
NCT Number: NCT03557645
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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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Niterói, Rio de Janeiro, 24241-002, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV).
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory pause.
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) without an inspiratory pause.
Time frame: Baseline (before) and 10 minutes after the onset of VHI modesBasel
Estimation of cardiac output variation using thoracic bioimpedance
Time frame: Baseline (before) and 10 minutes after the onset of VHI modes
Estimation of cardiac index variation using thoracic bioimpedance
Time frame: Baseline (before) and 10 minutes after the onset of VHI modes
Estimation of vascular pulmonary resistance variation using thoracic bioimpedance
Time frame: Baseline (before) and 10 minutes after the onset of VHI modes
Estimation of systolic volume variation using thoracic bioimpedance
Time frame: Baseline (before) and 10 minutes after the onset of VHI modes
Recording of mean arterial pressure variation using an automatic noninvasive device
Time frame: Baseline (before) and 5 minutes after the end of VHI modes
Estimation of cardiac output variation using thoracic bioimpedance
Time frame: Baseline (before) and 5 minutes after the end of VHI modes
Estimation of cardiac index variation using thoracic bioimpedance
Time frame: Baseline (before) and 5 minutes after the end of VHI modes
Estimation of vascular pulmonary resistance variation using thoracic bioimpedance
Time frame: Baseline (before) and 5 minutes after the end of VHI modes
Estimation of systolic volume variation using thoracic bioimpedance
Time frame: Baseline (before) and 5 minutes after the end of VHI modes
Recording of mean arterial pressure variation using an automatic noninvasive device
Centro Universitário Augusto Motta
Other
Hemodynamic Repercussions of Ventilator Hyperinflation Using Volume-controlled Ventilation: a Randomized Controlled Trial
Acronym: VHI-HD
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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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