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Selecting the Best Ventilator Hyperinflation Settings

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03327610
Acronym
VHI1
Enrollment
30
Registered
2017-10-31
Start date
2016-07-31
Completion date
2017-08-31
Last updated
2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration Disorders, Respiratory Failure

Keywords

Respiratory Therapy, Positive Pressure Respiration, Physical Therapy Modalities

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.

Interventions

OTHERVC-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.

OTHERVC-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.

OTHERPC-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.

OTHERPC-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.

OTHERPSV10

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.

OTHERPSV25

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.

Sponsors

Universidade Federal do Rio de Janeiro
CollaboratorOTHER
Centro Universitário Augusto Motta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peak inspiratory to expiratory flow ratioTen minutes after the onset of intervention.Dichotomous variable, defined as achieving a peak inspiratory flow rate (PIFR) less than 90% of the peak expiratory flow rate (PEFR)
Peak expiratory flow higher than 40 LpmTen minutes after the onset of intervention.Dichotomous variable, defined as achieving a PEFR higher than 40 l/min
Difference between peak inspiratory and expiratory flows.Ten minutes after the onset of intervention.Dichotomous variable, defined as achieving a difference higher than 17Lpm.
Pulmonary expansionTen minutes after the onset of intervention.Percentage of tidal volume above the normal tidal volume (estimated as 6mL/kg).

Secondary

MeasureTime frameDescription
Mean arterial pressureTen minutes after the onset of intervention.Mean arterial pressure verified using the multi-parameter monitor.
Heart RateTen minutes after the onset of intervention.Heart rate verified using the multi-parameter monitor.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026