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Ventilator Hyperinflation and Hemodynamics (VHI-HD)

Primary Purpose

Respiratory Failure, Respiratory Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Baseline Mechanical Ventilation
VHI With Inspiratory Pause
VHI Without Inspiratory Pause
Sponsored by
Centro Universitário Augusto Motta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring mechanical ventilation, physiotherapy, ventilator hyperinflation, airway clearance technique

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Santa Martha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Baseline Mechanical Ventilation

VHI With Inspiratory Pause

VHI Without Inspiratory Pause

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Cardiac Output
Estimation of cardiac output variation using thoracic bioimpedance

Secondary Outcome Measures

Change in Cardiac Index
Estimation of cardiac index variation using thoracic bioimpedance
Change in Vascular pulmonary resistance
Estimation of vascular pulmonary resistance variation using thoracic bioimpedance
Change in Systolic Volume
Estimation of systolic volume variation using thoracic bioimpedance
Change in Mean Arterial Pressure
Recording of mean arterial pressure variation using an automatic noninvasive device
Change in Cardiac Output II
Estimation of cardiac output variation using thoracic bioimpedance
Change in Cardiac Index II
Estimation of cardiac index variation using thoracic bioimpedance
Change in Vascular pulmonary resistance II
Estimation of vascular pulmonary resistance variation using thoracic bioimpedance
Change in Systolic Volume II
Estimation of systolic volume variation using thoracic bioimpedance
Change in Mean Arterial Pressure II
Recording of mean arterial pressure variation using an automatic noninvasive device

Full Information

First Posted
May 13, 2018
Last Updated
August 12, 2020
Sponsor
Centro Universitário Augusto Motta
Collaborators
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT03557645
Brief Title
Ventilator Hyperinflation and Hemodynamics
Acronym
VHI-HD
Official Title
Hemodynamic Repercussions of Ventilator Hyperinflation Using Volume-controlled Ventilation: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2017 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Universitário Augusto Motta
Collaborators
Universidade Federal do Rio de Janeiro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Respiratory Disorders
Keywords
mechanical ventilation, physiotherapy, ventilator hyperinflation, airway clearance technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline Mechanical Ventilation
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
VHI With Inspiratory Pause
Arm Type
Experimental
Arm Description
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.
Arm Title
VHI Without Inspiratory Pause
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Baseline Mechanical Ventilation
Intervention Description
The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV).
Intervention Type
Device
Intervention Name(s)
VHI With Inspiratory Pause
Intervention Description
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory pause.
Intervention Type
Device
Intervention Name(s)
VHI Without Inspiratory Pause
Intervention Description
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) without an inspiratory pause.
Primary Outcome Measure Information:
Title
Change in Cardiac Output
Description
Estimation of cardiac output variation using thoracic bioimpedance
Time Frame
Baseline (before) and 10 minutes after the onset of VHI modesBasel
Secondary Outcome Measure Information:
Title
Change in Cardiac Index
Description
Estimation of cardiac index variation using thoracic bioimpedance
Time Frame
Baseline (before) and 10 minutes after the onset of VHI modes
Title
Change in Vascular pulmonary resistance
Description
Estimation of vascular pulmonary resistance variation using thoracic bioimpedance
Time Frame
Baseline (before) and 10 minutes after the onset of VHI modes
Title
Change in Systolic Volume
Description
Estimation of systolic volume variation using thoracic bioimpedance
Time Frame
Baseline (before) and 10 minutes after the onset of VHI modes
Title
Change in Mean Arterial Pressure
Description
Recording of mean arterial pressure variation using an automatic noninvasive device
Time Frame
Baseline (before) and 10 minutes after the onset of VHI modes
Title
Change in Cardiac Output II
Description
Estimation of cardiac output variation using thoracic bioimpedance
Time Frame
Baseline (before) and 5 minutes after the end of VHI modes
Title
Change in Cardiac Index II
Description
Estimation of cardiac index variation using thoracic bioimpedance
Time Frame
Baseline (before) and 5 minutes after the end of VHI modes
Title
Change in Vascular pulmonary resistance II
Description
Estimation of vascular pulmonary resistance variation using thoracic bioimpedance
Time Frame
Baseline (before) and 5 minutes after the end of VHI modes
Title
Change in Systolic Volume II
Description
Estimation of systolic volume variation using thoracic bioimpedance
Time Frame
Baseline (before) and 5 minutes after the end of VHI modes
Title
Change in Mean Arterial Pressure II
Description
Recording of mean arterial pressure variation using an automatic noninvasive device
Time Frame
Baseline (before) and 5 minutes after the end of VHI modes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Guimaraes, PhD
Organizational Affiliation
Centro Universitário Augusto Motta
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Santa Martha
City
Niterói
State/Province
Rio De Janeiro
ZIP/Postal Code
24241-002
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
12109234
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. doi: 10.1002/pri.246.
Results Reference
result
PubMed Identifier
19929767
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. doi: 10.1016/s0004-9514(09)70004-2.
Results Reference
result
PubMed Identifier
25453540
Citation
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.
Results Reference
result

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Ventilator Hyperinflation and Hemodynamics

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