NCT03557645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

May 13, 2018

Last Update Submit

August 12, 2020

Conditions

Respiratory FailureRespiratory Disorders

Keywords

mechanical ventilationphysiotherapyventilator hyperinflationairway clearance technique

Outcome Measures

Primary Outcomes (1)

  • Change in Cardiac Output

    Estimation of cardiac output variation using thoracic bioimpedance

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

Secondary Outcomes (9)

  • Change in Cardiac Index

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

  • Change in Vascular pulmonary resistance

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

  • Change in Systolic Volume

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

  • Change in Mean Arterial Pressure

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

  • Change in Cardiac Output II

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

  • +4 more secondary outcomes

Study Arms (3)

Baseline Mechanical Ventilation

SHAM COMPARATOR

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

VHI With Inspiratory Pause

EXPERIMENTAL

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

VHI Without Inspiratory Pause

EXPERIMENTAL

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

Interventions

Baseline Mechanical VentilationDEVICE

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

Baseline Mechanical Ventilation
VHI With Inspiratory PauseDEVICE

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

VHI With Inspiratory Pause
VHI Without Inspiratory PauseDEVICE

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

VHI Without Inspiratory Pause

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients under mechanical ventilation for more than 48h

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Santa Martha

Niterói, Rio de Janeiro, 24241-002, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 12109234RESULT

  • 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.

    PMID: 19929767RESULT

  • 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.

    PMID: 25453540RESULT

Related Links

MeSH Terms

Conditions

Respiratory InsufficiencyRespiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Fernando Guimaraes, PhD

    Centro Universitário Augusto Motta

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2018

First Posted

June 15, 2018

Study Start

November 5, 2017

Primary Completion

September 20, 2018

Study Completion

September 30, 2018

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

BR(1)