Adaptive Support Ventilation in Acute Respiratory Distress Syndrome (ARDS)
Adaptive Support Ventilation vs. Conventional Ventilation Strategy in the Management of Acute Respiratory Distress Syndrome:A Randomized Controlled Trial
Prospective randomized controlled trial to be conducted in the Respiratory Intensive Care Unit (RICU) of Post Graduate Institute of Medical Education And Research (PGIMER),Chandigarh. The study is approved by the Institute Ethics committee. In view of lack of previous outcome data in such patients, all patients requiring RICU admission for acute respiratory distress syndrome(ARDS) between January 2010 and June 2011 are being enrolled in this pilot study.
The patients meeting the aforementioned criteria will randomly assigned to ventilation with assist control mode ventilation (ACMV group) as per the ARDSnet strategy or adaptive support ventilation (ASV group). Being the first RCT of its type, patients will be first stabilized on ACMV for 1 hour to determine the adequate minute ventilation. The randomization sequence will be computer generated. The assignments will placed in sealed opaque envelopes and each patient's assignment was made on admission to the RICU by the attending physician. Blinding of treatment is not possible.
All patients will be ventilated only by Galileo Gold ventilators (Hamilton medical systems, Bonaduz, Switzerland). Patients randomized to the ACMV group will be ventilated according to low tidal volume strategy of 6ml/kg with Fio2/PEEP as per ARDSnet table to achieve a saturation between 88-95% with the lowest possible Fio2 to maintain plateau pressures < 30 cms H2o and PH > 7.3 with option to reduce tidal volume to 4 ml/kg and increase respiratory rate to 35/ min to achieve the above said goals11.These patients will be weaned as per standard protocol of spontaneous breathing trial of 30 minutes once they are recognized eligible as per statement of the sixth International consensus conference on weaning.
調査の概要
詳細な説明
Inclusion criteria:
Study to include at least 40 patients admitted to RICU with diagnosis of ARDS as defined by American European consensus committee in 1994.
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion criteria:
- Age less than 12 years
- Patients having underlying chronic lung disease (COPD, interstitial lung disease, pulmonary hypertension)
- Contraindication to permissive hypercapnea (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy)
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Chandigarh、インド、160012
- 募集
- Respiratory intensive care unit, PGIMER
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コンタクト:
- Ritesh Agarwal, MD, DM, MAMS, FCCP
- 電話番号:2756825 9914209825
- メール:riteshpgi@gmail.com
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主任研究者:
- Arjun Srinivasan, M.D.
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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:
- Acute onset shortness of breath(<7 days)
- PaO2/FiO2 < 200 mm Hg (regardless of PEEP)
- Bilateral infiltrates on frontal chest radiograph
- <18 mm Hg when measured or no clinical evidence of left atrial hypertension
Exclusion Criteria:
- Age less than 12 years
- Patients having underlying chronic lung disease
- Contraindication to permissive hypercapnia (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, 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:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Adaptive support ventilation in ARDS
patients of ARDS will be randomized to this arm to receive mechanical ventilation as per ASV protocol
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patients are randomized to receive one of the two types of mechanical ventilation for ARDS
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アクティブコンパレータ:conventional ventilation strategy in ARDS
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patients are randomized to receive one of the two types of mechanical ventilation for ARDS
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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 |
時間枠 |
|---|---|
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Duration of mechanical ventilation
時間枠:up to 4 weeks
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up to 4 weeks
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duration of ICU stay
時間枠:up to 4 weeks
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up to 4 weeks
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duration of hospital stay
時間枠:up to 8 weeks
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up to 8 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Mortality
時間枠:up to 8 weeks
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up to 8 weeks
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ease of use of ventilator mode
時間枠:up to 4 weeks
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up to 4 weeks
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frequency of blood gas analysis
時間枠:up to 4 weeks
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up to 4 weeks
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協力者と研究者
捜査官
- 主任研究者:Arjun srinivasan, M.D.、dept of pulmonary medicine & critical care, PGIMER
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 (予想される)
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 (見積もり)
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
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