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| Name | Class |
|---|---|
| Universidade Federal do Rio de Janeiro | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline Mechanical Ventilation | Sham Comparator | The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow = 60Lpm and tidal volume = 6mL/IBW. Positive end-expiratory pressure and the inspired oxygen fraction will not be modified. |
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| VHI With Inspiratory Pause | Experimental | Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow will be set at 20Lpm, the tidal volume will be increased in steps of 200mL until the peak airway pressure of 40cmH2O is achieved, and an inspiratory pause will be applied at the end of inspiration. After achieving the target pressure, this ventilatory regimen will last 15 minutes. Positive end-expiratory pressure and the inspired oxygen fraction will not be modified. |
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| VHI Without Inspiratory Pause | Experimental | Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow will be set at 20Lpm and the tidal volume will be increased in steps of 200mL until the peak airway pressure of 40cmH2O is achieved. After achieving the target pressure, this ventilatory regimen will last 15 minutes. Positive end-expiratory pressure and the inspired oxygen fraction will not be modified. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline Mechanical Ventilation | Device | The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Output | Estimation of cardiac output variation using thoracic bioimpedance | Baseline (before) and 10 minutes after the onset of VHI modesBasel |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Index | Estimation of cardiac index variation using thoracic bioimpedance | Baseline (before) and 10 minutes after the onset of VHI modes |
| Change in Vascular pulmonary resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Guimaraes, PhD | Centro Universitário Augusto Motta | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Santa Martha | Niterói | Rio de Janeiro | 24241-002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12109234 | Result | 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. | |
| 19929767 | Result | 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. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Crossover Assignment
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| 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. |
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Estimation of vascular pulmonary resistance variation using thoracic bioimpedance
| Baseline (before) and 10 minutes after the onset of VHI modes |
| Change in Systolic Volume | Estimation of systolic volume variation using thoracic bioimpedance | Baseline (before) and 10 minutes after the onset of VHI modes |
| Change in Mean Arterial Pressure | Recording of mean arterial pressure variation using an automatic noninvasive device | Baseline (before) and 10 minutes after the onset of VHI modes |
| Change in Cardiac Output II | Estimation of cardiac output variation using thoracic bioimpedance | Baseline (before) and 5 minutes after the end of VHI modes |
| Change in Cardiac Index II | Estimation of cardiac index variation using thoracic bioimpedance | Baseline (before) and 5 minutes after the end of VHI modes |
| Change in Vascular pulmonary resistance II | Estimation of vascular pulmonary resistance variation using thoracic bioimpedance | Baseline (before) and 5 minutes after the end of VHI modes |
| Change in Systolic Volume II | Estimation of systolic volume variation using thoracic bioimpedance | Baseline (before) and 5 minutes after the end of VHI modes |
| Change in Mean Arterial Pressure II | Recording of mean arterial pressure variation using an automatic noninvasive device | Baseline (before) and 5 minutes after the end of VHI modes |
| 25453540 | Result | 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. |