Respiratory Failure Clinical Trial
— VHI-HDOfficial title:
Hemodynamic Repercussions of Ventilator Hyperinflation Using Volume-controlled Ventilation: a Randomized Controlled Trial
Verified date | August 2020 |
Source | Centro Universitário Augusto Motta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Santa Martha | Niterói | Rio De Janeiro |
Lead Sponsor | Collaborator |
---|---|
Centro Universitário Augusto Motta | Universidade Federal do Rio de Janeiro |
Brazil,
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.phy — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Cardiac Output | Estimation of cardiac output variation using thoracic bioimpedance | Baseline (before) and 10 minutes after the onset of VHI modesBasel | |
Secondary | Change in Cardiac Index | Estimation of cardiac index variation using thoracic bioimpedance | Baseline (before) and 10 minutes after the onset of VHI modes | |
Secondary | Change in Vascular pulmonary resistance | Estimation of vascular pulmonary resistance variation using thoracic bioimpedance | Baseline (before) and 10 minutes after the onset of VHI modes | |
Secondary | Change in Systolic Volume | Estimation of systolic volume variation using thoracic bioimpedance | Baseline (before) and 10 minutes after the onset of VHI modes | |
Secondary | 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 | |
Secondary | Change in Cardiac Output II | Estimation of cardiac output variation using thoracic bioimpedance | Baseline (before) and 5 minutes after the end of VHI modes | |
Secondary | Change in Cardiac Index II | Estimation of cardiac index variation using thoracic bioimpedance | Baseline (before) and 5 minutes after the end of VHI modes | |
Secondary | 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 | |
Secondary | Change in Systolic Volume II | Estimation of systolic volume variation using thoracic bioimpedance | Baseline (before) and 5 minutes after the end of VHI modes | |
Secondary | 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 |
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