Selecting the Best Ventilator Hyperinflation Settings (VHI1)
27 oktober 2017 uppdaterad av: Fernando Silva Guimaraes, Centro Universitário Augusto Motta
Selecting the Best Ventilator Hyperinflation Settings Based on Physiologic Markers: Randomized Controlled Study
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
30
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: BASELINE
The subjects were kept in their current ventilatory mode.
|
|
|
Experimentell: VC-CMV20
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 20Lpm.
|
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.
|
|
Experimentell: VC-CMV50
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 50Lpm.
|
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.
|
|
Experimentell: PC-CMV1
Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 1 second.
|
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.
|
|
Experimentell: PC-CMV3
Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 3 seconds.
|
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.
|
|
Experimentell: PSV10
Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 10% of peak inspiratory flow.
|
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.
|
|
Experimentell: PSV25
Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 25% of peak inspiratory flow.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Peak inspiratory to expiratory flow ratio
Tidsram: Ten 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)
|
Ten minutes after the onset of intervention.
|
|
Peak expiratory flow higher than 40 Lpm
Tidsram: Ten minutes after the onset of intervention.
|
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.
Tidsram: Ten minutes after the onset of intervention.
|
Dichotomous variable, defined as achieving a difference higher than 17Lpm.
|
Ten minutes after the onset of intervention.
|
|
Pulmonary expansion
Tidsram: Ten minutes after the onset of intervention.
|
Percentage of tidal volume above the normal tidal volume (estimated as 6mL/kg).
|
Ten minutes after the onset of intervention.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean arterial pressure
Tidsram: Ten minutes after the onset of intervention.
|
Mean arterial pressure verified using the multi-parameter monitor.
|
Ten minutes after the onset of intervention.
|
|
Heart Rate
Tidsram: Ten minutes after the onset of intervention.
|
Heart rate verified using the multi-parameter monitor.
|
Ten minutes after the onset of intervention.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studiestol: FERNANDO S GUIMARAES, PhD, Centro Universitário Augusto Motta
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- de Wit M. Monitoring of patient-ventilator interaction at the bedside. Respir Care. 2011 Jan;56(1):61-72. doi: 10.4187/respcare.01077.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2016
Primärt slutförande (Faktisk)
1 augusti 2017
Avslutad studie (Faktisk)
1 augusti 2017
Studieregistreringsdatum
Först inskickad
27 oktober 2017
Först inskickad som uppfyllde QC-kriterierna
27 oktober 2017
Första postat (Faktisk)
31 oktober 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 oktober 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 oktober 2017
Senast verifierad
1 oktober 2017
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VHI1
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