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Respiratory FailureVHI-HDNCT03557645

Ventilator Hyperinflation and Hemodynamics

A study testing Baseline Mechanical Ventilation, VHI With Inspiratory Pause and VHI Without Inspiratory Pause in people with Respiratory Failure and Respiratory Disorders, run by Centro Universitário Augusto Motta at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Respiratory Failure, Respiratory Disorders
What is being tested?
Baseline Mechanical Ventilation, VHI With Inspiratory Pause and VHI Without Inspiratory Pause
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteBrazil
Study dates
5 Nov 2017to 30 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients under mechanical ventilation for more than 48h

Who cannot join

  • 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,
Show all 9Show fewer
  • mean arterial pressure < 60mmHg,
  • inotrope requirement equivalent to >15 ml/h total of adrenaline and noradrenalin,
  • intracranial pressure > 20mmHg

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Santa Martha

    Niterói, Rio de Janeiro, 24241-002

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Baseline Mechanical Ventilation, VHI With Inspiratory Pause, VHI Without Inspiratory Pause
Keywords
mechanical ventilation, physiotherapy, ventilator hyperinflation, airway clearance technique
Medical subject headings
Respiratory Insufficiency, Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baseline Mechanical VentilationDevice

    The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV).

  • VHI With Inspiratory PauseDevice

    Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory pause.

  • VHI Without Inspiratory PauseDevice

    Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) without an inspiratory pause.

Study groups in NCT03557645
Study groupRoleWhat they receive
Baseline Mechanical VentilationSham comparatorThe 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.
Receives: Device: Baseline Mechanical Ventilation
VHI With Inspiratory PauseExperimentalApplication 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.
Receives: Device: VHI With Inspiratory Pause
VHI Without Inspiratory PauseExperimentalApplication 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.
Receives: Device: VHI Without Inspiratory Pause

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cardiac Output

    Estimation of cardiac output variation using thoracic bioimpedance

    Measured: Baseline (before) and 10 minutes after the onset of VHI modesBasel

Secondary outcomes (9)

  1. Change in Cardiac Index

    Estimation of cardiac index variation using thoracic bioimpedance

    Measured: Baseline (before) and 10 minutes after the onset of VHI modes

  2. Change in Vascular pulmonary resistance

    Estimation of vascular pulmonary resistance variation using thoracic bioimpedance

    Measured: Baseline (before) and 10 minutes after the onset of VHI modes

  3. Change in Systolic Volume

    Estimation of systolic volume variation using thoracic bioimpedance

    Measured: Baseline (before) and 10 minutes after the onset of VHI modes

  4. Change in Mean Arterial Pressure

    Recording of mean arterial pressure variation using an automatic noninvasive device

    Measured: Baseline (before) and 10 minutes after the onset of VHI modes

  5. Change in Cardiac Output II

    Estimation of cardiac output variation using thoracic bioimpedance

    Measured: Baseline (before) and 5 minutes after the end of VHI modes

  6. Change in Cardiac Index II

    Estimation of cardiac index variation using thoracic bioimpedance

    Measured: Baseline (before) and 5 minutes after the end of VHI modes

  7. Change in Vascular pulmonary resistance II

    Estimation of vascular pulmonary resistance variation using thoracic bioimpedance

    Measured: Baseline (before) and 5 minutes after the end of VHI modes

  8. Change in Systolic Volume II

    Estimation of systolic volume variation using thoracic bioimpedance

    Measured: Baseline (before) and 5 minutes after the end of VHI modes

  9. Change in Mean Arterial Pressure II

    Recording of mean arterial pressure variation using an automatic noninvasive device

    Measured: Baseline (before) and 5 minutes after the end of VHI modes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2018
  2. Study start5 Nov 2017
  3. Primary completion20 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Crossover Assignment
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03557645
Sponsor's protocol ID
VHI Hemodynamics
Acronym
VHI-HD
Status last verified
Aug 2020
First submitted
13 May 2018
Last updated
14 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 12109234

  • 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.

    PubMed 19929767

  • 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.

    PubMed 25453540

Questions about this trial

What is this clinical trial studying?

A study testing Baseline Mechanical Ventilation, VHI With Inspiratory Pause and VHI Without Inspiratory Pause in people with Respiratory Failure and Respiratory Disorders, run by Centro Universitário Augusto Motta at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cardiac Output (time frame: Baseline (before) and 10 minutes after the onset of VHI modesBasel). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03557645, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.

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