Selecting the Best Ventilator Hyperinflation Settings (VHI1)
2017年10月27日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
30
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：BASELINE
The subjects were kept in their current ventilatory mode.
|
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Peak inspiratory to expiratory flow ratio
時間枠：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
時間枠：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.
時間枠：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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean arterial pressure
時間枠：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
時間枠：Ten minutes after the onset of intervention.
|
Heart rate verified using the multi-parameter monitor.
|
Ten minutes after the onset of intervention.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：FERNANDO S GUIMARAES, PhD、Centro Universitário Augusto Motta
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年7月1日
一次修了 (実際)
2017年8月1日
研究の完了 (実際)
2017年8月1日
試験登録日
最初に提出
2017年10月27日
QC基準を満たした最初の提出物
2017年10月27日
最初の投稿 (実際)
2017年10月31日
学習記録の更新
投稿された最後の更新 (実際)
2017年10月31日
QC基準を満たした最後の更新が送信されました
2017年10月27日
最終確認日
2017年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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