Work of Breathing Assessment During Weaning From Mechanical Ventilation (WOAW)
Introduction In patients assisted by mechanical ventilation, the Work Of Breathing (WOB) is shared between the patient and the ventilator. During weaning from mechanical ventilation, the WOB performed by the patient must be adequate and efficient to sustain spontaneous ventilation after extubation. The monitoring of WOB during weaning might allow a better management of the weaning process. Esophageal pressure (PES) is the reference technique to measure WOB but alternate tools have been proposed. The main hypothesis is that Indirect Calorimetry (IC) is valid to track the changes in energy expenditure due to the changes in WOB in mechanically ventilated children during weaning from mechanical ventilation. The primary objective of this study is to assess the validity of IC method for the WOB assessment when compared to PES measurement and Electrical Activity of the diaphragm (EAdi) during a spontaneous breathing trial (SBT) in continuous positive airway pressure, which is a routine extubation readiness test which generally induces an increase in WOB.
Methods This is a prospective single center study. All intubated and mechanically ventilated children >1 months and <18 years old, hospitalized in the pediatric intensive care unit will be eligible.
Simultaneous recordings of Energy Expenditure, PES and EAdi will be performed during 3 steps: before, during and after the SBT. Then outcome of patients will be collected.
The investigators plan to study a sample of 15 patients to be representative.
Relevance to the importance of child health in Canada The investigators expect that the IC-based less invasive method will provide an accurate estimation of WOB assessment. Once this tool is validated, the interest of IC to (i) early detect an increase in WOB during mechanical ventilation in children, (ii) to assess the ability to extubate them and (iii) to optimize nutritional support will be assessed in future studies.
調査の概要
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
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Quebec
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Montreal、Quebec、カナダ、H3T 1C5
- St. Justine's Hospital
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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:
All intubated and mechanically ventilated children >1 months and <18 years old, hospitalized in the pediatric intensive care unit will be eligible.
The patient is deemed to be ready for an extubation readiness test as per the attending team. In particular, the following criteria should be met:
- Improvement in the underlying condition that led to intubation;
- Presence of spontaneous breathing, and adequate oxygenation:, FiO2 ≤ 0.6 (to obtain a SpO2 between 92 and 97%), with Positive End Expiratory Pressure < 8 cmH2O;
- Adequate mental status: Arousal;
- Effective cough;
- No planned operative procedure requiring heavy sedation in the next 12 hours.
Exclusion Criteria:
- Contraindications to the placement of a new nasogastric tube (e.g. trauma or recent surgery in cervical, esophageal, or nasopharyngeal regions, severe coagulation disorder);
- Hemodynamic instability requiring milrinone ≥ 0.5µg/kg/min, dopamine ≥ 5µg/kg/min, epinephrine ≥ 0.03µg/kg/min, norepinephrine ≥ 0.03µg/kg/min, or dobutamine ≥ 5µg/kg/min;
- Severe respiratory instability, and in particular PaCO2 > 80 mmHg on the last blood gas in the last 4 hours;
- Axillary temperature >38°;
- Cuff leaks >10%, calculated by the ventilator as mean inspired tidal volume minus mean expired tidal volume divided by inspired tidal volume;
- Absence of parental or tutor consent;
- Patient for whom a limitation of life support treatments is discussed or decided.
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：他の
- 割り当て：なし
- 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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実験的：忍耐
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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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Change in Oxygen Consumption, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.
時間枠：Up to 2 hours from the beginning of the study
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Up to 2 hours from the beginning of the study
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Change in Energy Expenditure, measured during 3 periods of 30 minutes: before (STEP 1), during (STEP 2) and after (STEP 3) the SBT.
時間枠：Up to 2 hours from the beginning of the study
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Up to 2 hours from the beginning of the study
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Esophageal pressure
時間枠：Up to 2 hours from the beginning of the study
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Esophageal, calculated as the mean value of 10 consecutive breaths, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;
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Up to 2 hours from the beginning of the study
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Change in Esophageal pressure time product
時間枠：Up to 2 hours from the beginning of the study
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Pressure Time Product, calculated as the mean value of 10 consecutive breaths, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;
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Up to 2 hours from the beginning of the study
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Change in Electrical Activity of the diaphragm (EAdi)
時間枠：Up to 2 hours from the beginning of the study
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EAdi, calculated as the mean inspiratory value during 1 minute, before (STEP 1), during (STEP 2) and after (STEP 3) the SBT;
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Up to 2 hours from the beginning of the study
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Change in Respiratory Rate
時間枠：Up to 2 hours from the beginning of the study
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Respiratory Rate, monitored during the SBT;
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Up to 2 hours from the beginning of the study
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Change in Cardiac Rate
時間枠：Up to 2 hours from the beginning of the study
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Cardiac Rate, monitored during the SBT;
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Up to 2 hours from the beginning of the study
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Duration of mechanical ventilation
時間枠：Up to 3 months
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Up to 3 months
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Spontaneous Breathing test success or failure
時間枠：Up to 28 hours
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extubation success or failure (as defined by the need to re-intubate in the 24 hours following extubation).
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Up to 28 hours
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協力者と研究者
スポンサー
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
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