Trilogy Comparison Study - Adults
Comparing Known Modes of Ventilation Delivered by Trilogy Versus Conventional Mechanical Ventilators
調査の概要
詳細な説明
A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as partial pressure of CO2 in arterial or venous blood)and SpO2 levels during various modes of ventilation.
B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Manitoba
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Winnipeg、Manitoba、カナダ、R3E 0Z3
- University of Manitoba
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age > 21 years of age; < 85 years of age
- Able to follow instructions
- Able to provide informed consent
- Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O.
- Requiring mechanical ventilation through nasal/facial mask,tracheostomy or endotracheal tube (ET Tube)
Exclusion Criteria:
Clinically unstable, i.e.,
- Acute Respiratory Failure
- Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents),
- Uncontrolled cardiac ischemia or arrhythmias,
- or as otherwise determined inappropriate for the study as determined by the investigator.
- Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
- Pregnancy
研究計画
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 |
|---|---|
|
実験的：Trilogy
Trilogy Device
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Exposure for one hour on the Trilogy ventilator
|
|
アクティブコンパレータ：Standard of Care
Participants prescribed ventilator
|
Exposure to participants current ventilator
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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 |
|---|---|---|
|
Comparable Level of Gas Exchange (Measured as Partial Pressure of CO2 in Arterial or Venous Blood).
時間枠：After one hour of ventilator use
|
Blood gas was obtained for this study one hour after use of each device.
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After one hour of ventilator use
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Comparable Level of Gas Exchange SpO2 Levels During Various Modes of Ventilation.
時間枠：After one hour of ventilator use
|
Pulse Oximetry was measured after one hour of use of each ventilator.
|
After one hour of ventilator use
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tidal Volume
時間枠：One hour during ventilator use.
|
Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.
It measures around 500 mL in an average healthy adult male and approximately 400 mL in a healthy female.
Average tidal volume was compare after a hour of use of each device.
|
One hour during ventilator use.
|
|
Minute Ventilation
時間枠：One hour during ventilator use.
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Minute ventilation is the volume of gas inhaled or exhaled from a person's lungs per minute.
This was measured after one hour of use of each device.
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One hour during ventilator use.
|
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Hemodynamics (Heart Rate)
時間枠：One hour during ventilator use.
|
Number of beats per minute.
Measured after one hour of use of each device.
|
One hour during ventilator use.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Steven Mink, MD、University of Manitoba
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。