Ventilator Hyperinflation and Hemodynamics

Respiratory Failure Clinical Trial

— VHI-HD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557645
• Other study ID #: VHI Hemodynamics
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disorders
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Tract Diseases

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

External Links

•   Main researcher - personal profile in Researchgate