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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03557645
Other study ID # VHI Hemodynamics
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2017
Est. completion date September 30, 2018

Study information

Verified date August 2020
Source Centro Universitário Augusto Motta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Baseline Mechanical Ventilation
The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV).
VHI With Inspiratory Pause
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory pause.
VHI Without Inspiratory Pause
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) without an inspiratory pause.

Locations

Country Name City State
Brazil Hospital Santa Martha Niterói Rio De Janeiro

Sponsors (2)

Lead Sponsor Collaborator
Centro Universitário Augusto Motta Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

Outcome

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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