Clinical trial NCT03327610: Selecting the Best Ventilator Hyperinflation Settings
Official title: Selecting the Best Ventilator Hyperinflation Settings Based on Physiologic Markers: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Respiration Disorders
Keywords: Respiratory Therapy
Positive Pressure Respiration
Physical Therapy Modalities
Lead sponsor: Centro Universitário Augusto Motta
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio de Janeiro
First posted: 2017-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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, 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.

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

Primary outcomes:
measure: Peak inspiratory to expiratory flow ratio
timeFrame: Ten minutes after the onset of intervention.
measure: Peak expiratory flow higher than 40 Lpm
timeFrame: Ten minutes after the onset of intervention.
measure: Difference between peak inspiratory and expiratory flows.
timeFrame: Ten minutes after the onset of intervention.
measure: Pulmonary expansion
timeFrame: Ten minutes after the onset of intervention.
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: Ten minutes after the onset of intervention.
measure: Heart Rate
timeFrame: Ten minutes after the onset of intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Centro Universitário Augusto Motta
name: FERNANDO S GUIMARAES, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1002/pri.246.
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. doi: 10.1016/s0004-9514(09)70004-2.
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. doi: 10.1177/0310057X1504300112.
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.
citation: 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.
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.
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.