Selecting the Best Ventilator Hyperinflation Settings

Respiratory Failure Clinical Trial

— VHI1  

Official title:

Selecting the Best Ventilator Hyperinflation Settings Based on Physiologic Markers: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327610
• Other study ID #: VHI1
• Status: Completed
• Phase: N/A
• First received: October 27, 2017
• Last updated: October 27, 2017
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Centro Universitário Augusto Motta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centro Universitário Augusto Motta	Universidade Federal do Rio de Janeiro

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Difference between peak inspiratory and expiratory flows.	Dichotomous variable, defined as achieving a difference higher than 17Lpm.	Ten minutes after the onset of intervention.
Primary	Pulmonary expansion	Percentage of tidal volume above the normal tidal volume (estimated as 6mL/kg).	Ten minutes after the onset of intervention.
Secondary	Mean arterial pressure	Mean arterial pressure verified using the multi-parameter monitor.	Ten minutes after the onset of intervention.
Secondary	Heart Rate	Heart rate verified using the multi-parameter monitor.	Ten minutes after the onset of intervention.

External Links

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