Selecting the Best Ventilator Hyperinflation Settings

NCT03327610 | Completed

• 1 other identifier: VHI1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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, 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.

Conditions

Respiratory Failure; Respiration Disorders

Keywords

Respiratory Therapy; Positive Pressure Respiration; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (4)

• Peak inspiratory to expiratory flow ratio

  Dichotomous variable, defined as achieving a peak inspiratory flow rate (PIFR) less than 90% of the peak expiratory flow rate (PEFR)

  Ten minutes after the onset of intervention.

• Peak expiratory flow higher than 40 Lpm

  Dichotomous variable, defined as achieving a PEFR higher than 40 l/min

  Ten minutes after the onset of intervention.

• Difference between peak inspiratory and expiratory flows.

  Dichotomous variable, defined as achieving a difference higher than 17Lpm.

  Ten minutes after the onset of intervention.

• Pulmonary expansion

  Percentage of tidal volume above the normal tidal volume (estimated as 6mL/kg).

  Ten minutes after the onset of intervention.

Secondary Outcomes (2)

• Mean arterial pressure

  Ten minutes after the onset of intervention.

• Heart Rate

  Ten minutes after the onset of intervention.

Study Arms (7)

BASELINE

NO INTERVENTION

The subjects were kept in their current ventilatory mode.

VC-CMV20

EXPERIMENTAL

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

Other: VC-CMV20

VC-CMV50

EXPERIMENTAL

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

Other: VC-CMV50

PC-CMV1

EXPERIMENTAL

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

Other: PC-CMV1

PC-CMV3

EXPERIMENTAL

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

Other: PC-CMV3

PSV10

EXPERIMENTAL

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

Other: PSV10

PSV25

EXPERIMENTAL

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

Other: PSV25

Interventions

VC-CMV20 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-CMV20

VC-CMV50 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.

VC-CMV50

PC-CMV1 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-CMV1

PC-CMV3 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.

PC-CMV3

PSV10 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.

PSV10

PSV25 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.

PSV25

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead
• Universidade Federal do Rio de Janeiro: collaborator

Related Publications (7)

• 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: 12109234 BACKGROUND

• 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: 19929767 BACKGROUND

• 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.

  PMID: 25579293 BACKGROUND

• 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.

  PMID: 21682986 BACKGROUND

• 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: 25453540 BACKGROUND

• 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.

  PMID: 27235313 BACKGROUND

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

  PMID: 21235839 BACKGROUND

Related Links

• Researchgate profile (Chair researcher)
• ResearcherID profile (Chair researcher)

MeSH Terms

Conditions

Respiratory Insufficiency; Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• FERNANDO S GUIMARAES, PhD

  Centro Universitário Augusto Motta

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: October 31, 2017
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share