Selecting the Best Ventilator Hyperinflation Settings

NCT ID: NCT03327610

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-08-31

Brief Summary

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Ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, there are no recommendations on the best ventilator settings to perform the technique. Thus, the aim of this study was to compare six modes of VHI, concerning physiological markers of efficacy and safety criteria, in order to support the optimal VHI settings selection for mechanically ventilated patients. In a randomized, controlled and crossover study, 30 mechanically ventilated patients underwent 6 modes of ventilator hyperinflation. The maximum expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow patterns), overdistension (alveolar pressure), asynchronies and hemodynamic variables (mean arterial pressure and heart rate) were assessed during the interventions.

Detailed Description

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Background: Ventilator Hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, there are no recommendations on the best ventilator settings to perform the technique. Thus, the aim of this study was to compare six modes of VHI, concerning physiological markers of efficacy and safety criteria, in order to support the optimal VHI settings selection for mechanically ventilated patients.

Methods: In a crossover study, every included mechanically ventilated patient underwent six modes of VHI in a randomized order: Volume Control Continuous Mandatory Ventilation (VC-CMV) with inspiratory flow = 20Lpm (VC-CMV20), VC-CMV with inspiratory flow = 50Lpm (VC-CMV50), Pressure Control Continuous Mandatory Ventilation (PC-CMV) with inspiratory time = 1s. (PC-CMV1), PC-CMV with inspiratory time = 3s. (PC-CMV3), Pressure Support Ventilation (PSV) with cycling off = 10% of peak inspiratory flow (PSV10), and PSV with cycling off = 25% of peak inspiratory flow (PSV25). The maximum expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow patterns), over-distension (alveolar pressure), asynchronies and hemodynamic variables (mean arterial pressure and heart rate) were assessed during the interventions.

Conditions

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Respiratory Failure Respiration Disorders

Keywords

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Respiratory Therapy Positive Pressure Respiration Physical Therapy Modalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BASELINE

The subjects were kept in their current ventilatory mode.

Group Type NO_INTERVENTION

No interventions assigned to this group

VC-CMV20

Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 20Lpm.

Group Type EXPERIMENTAL

VC-CMV20

Intervention Type OTHER

Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow was set at 20Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

VC-CMV50

Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 50Lpm.

Group Type EXPERIMENTAL

VC-CMV50

Intervention Type OTHER

Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow was set at 50Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

PC-CMV1

Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 1 second.

Group Type EXPERIMENTAL

PC-CMV1

Intervention Type OTHER

Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1). The inspiratory time was set at 1 second and the pressure control was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

PC-CMV3

Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 3 seconds.

Group Type EXPERIMENTAL

PC-CMV3

Intervention Type OTHER

Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1). The inspiratory time was set at 3 seconds and the pressure control was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

PSV10

Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 10% of peak inspiratory flow.

Group Type EXPERIMENTAL

PSV10

Intervention Type OTHER

Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV). The cycling off was set at 10% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

PSV25

Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 25% of peak inspiratory flow.

Group Type EXPERIMENTAL

PSV25

Intervention Type OTHER

Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV). The cycling off was set at 25% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

Interventions

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VC-CMV20

Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow was set at 20Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

Intervention Type OTHER

VC-CMV50

Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow was set at 50Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

Intervention Type OTHER

PC-CMV1

Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1). The inspiratory time was set at 1 second and the pressure control was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

Intervention Type OTHER

PC-CMV3

Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1). The inspiratory time was set at 3 seconds and the pressure control was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

Intervention Type OTHER

PSV10

Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV). The cycling off was set at 10% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

Intervention Type OTHER

PSV25

Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV). The cycling off was set at 25% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.

Intervention Type OTHER

Eligibility Criteria

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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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role collaborator

Centro Universitário Augusto Motta

OTHER

Sponsor Role lead

Responsible Party

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Fernando Silva Guimaraes

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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FERNANDO S GUIMARAES, PhD

Role: STUDY_CHAIR

Centro Universitário Augusto Motta

References

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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 BACKGROUND
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 BACKGROUND
PMID: 19929767 (View on PubMed)

Thomas PJ. The effect of mechanical ventilator settings during ventilator hyperinflation techniques: a bench-top analysis. Anaesth Intensive Care. 2015 Jan;43(1):81-7. doi: 10.1177/0310057X1504300112.

Reference Type BACKGROUND
PMID: 25579293 (View on PubMed)

Ntoumenopoulos G, Shannon H, Main E. Do commonly used ventilator settings for mechanically ventilated adults have the potential to embed secretions or promote clearance? Respir Care. 2011 Dec;56(12):1887-92. doi: 10.4187/respcare.01229. Epub 2011 Jun 17.

Reference Type BACKGROUND
PMID: 21682986 (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 BACKGROUND
PMID: 25453540 (View on PubMed)

Davies JD, Senussi MH, Mireles-Cabodevila E. Should A Tidal Volume of 6 mL/kg Be Used in All Patients? Respir Care. 2016 Jun;61(6):774-90. doi: 10.4187/respcare.04651.

Reference Type BACKGROUND
PMID: 27235313 (View on PubMed)

de Wit M. Monitoring of patient-ventilator interaction at the bedside. Respir Care. 2011 Jan;56(1):61-72. doi: 10.4187/respcare.01077.

Reference Type BACKGROUND
PMID: 21235839 (View on PubMed)

Related Links

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Other Identifiers

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VHI1

Identifier Type: -

Identifier Source: org_study_id