Ventilator Hyperinflation and Hemodynamics

NCT ID: NCT03557645

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-05
• Study Completion Date: 2018-09-30

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.

Conditions

Respiratory Failure; Respiratory Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Baseline Mechanical Ventilation

Intervention Type: DEVICE

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). 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.

Group Type: EXPERIMENTAL

VHI With Inspiratory Pause

Intervention Type: DEVICE

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). 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.

Group Type: EXPERIMENTAL

VHI Without Inspiratory Pause

Intervention Type: DEVICE

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

Interventions

Baseline Mechanical Ventilation

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

Intervention Type: DEVICE

VHI With Inspiratory Pause

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

Intervention Type: DEVICE

VHI Without Inspiratory Pause

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: collaborator

Centro Universitário Augusto Motta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Guimaraes, PhD

Role: STUDY_CHAIR

Centro Universitário Augusto Motta

Locations

Hospital Santa Martha

Niterói, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 12109234 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19929767 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25453540 (View on PubMed)

Other Identifiers

VHI Hemodynamics

Identifier Type: -

Identifier Source: org_study_id