Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
Adjustment of Non-invasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Ventilatory Failure Using Automated End-expiratory Pressure (AutoEEP) Algorithm
調査の概要
状態
詳細な説明
Persisting ventilatory failure associated with chronic obstructive pulmonary disease (COPD), obesity-hypoventilation-syndrome, sleep apnoea or neuromuscular disease is increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV).
Optimal settings of non-invasive ventilation are usually titrated manually and require time and expertise. The development of systems lead to automated analysis and development of algorithms to adjust ventilators. However, there is a paucity of optimal algorithms, particularly the problem of upper airway obstruction. Therefore, the central aim of this study is to develop the automated setting of an end-expiratory positive airway pressure (EPAP), because upper airway obstruction is relatively common in this group of patients. We hypothesise that an automated end-expiratory airway pressure (AutoEEP) adjusting algorithm could overcome these problems and further optimise and adjust ventilator settings. Using non-invasive ventilation in patients with hypercapnic ventilatory failure, awake and asleep, we will measure physiological outcome parameters and apply an AutoEEP algorithm, comparing it against usual care.
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
-
-
-
Essen、ドイツ、45239
- Abteilung Pneumologie - Universitätsklinik, Ruhrlandklinik
-
-
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:
- Subjects will be patients not naive to noninvasive ventilation, and being so treated for any form of hypercapnic ventilatory failure.
- Previously stabilised on bilevel noninvasive pressure support ventilation.
- Both genders, age <75years.
- Previously shown to have a requirement for an EEP above cm H2O in order to maintain upper airway patency, or those in whom such a raised EEP would be expected, e.g. obese patients.
- Patients also known to have adequate airway patency at an EEP of 4 to 5 cm H2O will be included to ensure specificity of the algorithm.
Exclusion Criteria:
- Acute critical illness (e.g. acute coronary syndrome, stroke)
- Serious anatomical variations of nose, sinuses, pharynx or oesophagus.
- Any condition at risk of oesophageal bleeding (e.g. oesophageal varices, gastric ulcer, etc.)
- Age >75 years
- Pregnancy
- Epilepsy
- Psychiatric disorders that could possibly influence the study
- Any kind of addiction
- Insufficient knowledge of the language
- Noninvasive ventilation otherwise contraindicated
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：AutoVPAP with addition of AutoEPAP
This arm will receive conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure.
Patients randomised to this group will then receive the other treatment the following night.
|
Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.
Conventionally applied Expiratory Positive Airway Pressure (EPAP)
|
|
アクティブコンパレータ：AutoVPAP without addition of AutoEPAP
This arm will receive conventionally applied Expiratory Positive Airway Pressure.
Patients randomised to this group will then receive the other treatment the following night.
|
Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.
Conventionally applied Expiratory Positive Airway Pressure (EPAP)
|
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 |
|---|---|---|
|
Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI)
時間枠：On completion of each consecutive night of polysomnography.
|
The AHI is a count of the number of pauses during sleep a person experiences.
The total number of apneas/ hypopneas (sleep pauses) are divided by the total sleep time to get an index for that night
|
On completion of each consecutive night of polysomnography.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean SpO2
時間枠：On completion of each night of 2 consecutive nights polysomnography.
|
During sleep, pulse oximetery is recorded through a sensor on the participants finger
|
On completion of each night of 2 consecutive nights polysomnography.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Helmut Teschler, Dr. med.、Abteilung Pneumologie - Universitätsklinik, Essen, Germany
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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。