Ventilator Hyperinflation and Hemodynamics (VHI-HD)

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Respiratory Disorders
• Intervention / Treatment: Device: Baseline Mechanical Ventilation; Device: VHI With Inspiratory Pause; Device: VHI Without Inspiratory Pause

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro
    • Niterói, Rio De Janeiro, Brazil, 24241-002
      • Hospital Santa Martha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Baseline Mechanical Ventilation; 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.	Device: Baseline Mechanical Ventilation; The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV).
Experimental: VHI With Inspiratory Pause; 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.	Device: VHI With Inspiratory Pause; Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory pause.
Experimental: VHI Without Inspiratory Pause; 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.	Device: VHI Without Inspiratory Pause; Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) without an inspiratory pause.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centro Universitário Augusto Motta
• Collaborators: Universidade Federal do Rio de Janeiro
• Investigators: Study Chair: Fernando Guimaraes, PhD, Centro Universitário Augusto Motta

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2017
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: May 13, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: mechanical ventilation; physiotherapy; airway clearance technique; ventilator hyperinflation
• Additional Relevant MeSH Terms: Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: VHI Hemodynamics

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No