Use of High Flows in Pediatric Cardiac Surgical Patients
Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients
Humidified high flow nasal prong oxygen therapy is a method for providing oxygen and CPAP. The delivery of high flows decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase. In addition, a flow-dependent effect of continuous positive airway pressure, possibly due to an air entrainment mechanism, has been documented in healthy volunteers and in patients with COPD.
The investigators working hypothesis is that the use of post-extubation CPAP delivered via nasal cannulae in infants less than 18 months, post-bypass surgery will have better PaCO2 values than infants extubated on to oxygen therapy.
調査の概要
詳細な説明
After CICU admission, infants with no bleeding, normothermic and hemodynamically stable will be switched from PRVC to SIMV+PSV (10-15cmH20) which should be maintained for 4 hours. An arterial gas analysis will be performed after 20 minutes. Infants with normal gas-exchange are gradually weaned from mechanical ventilation At each weaning step an arterial hemogasanalysis is performed after 20 minutes, to assess if the decreased ventilatory support is tolerated. Increased work of breathing and respiratory acidosis (ph< 7.3 or pCO2 > 60 mmHg) are considered criteria to withhold the weaning process. After a 4 hour period on SIMV+PSV the child should be switched to PSV for 30 minutes and then extubated. The following extubation criteria should be reached:
- Satisfactory blood gases with PCO2 under 45mmHg, pH greater than 7.30.
- Fractional inspired oxygen concentration of 65% and or less than the baseline value
- Adequate respiratory frequency according to age without dyspnea
At this point criteria for extubation are reached. Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
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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Rome、イタリア、00165
- 募集
- Ospedale Bambino Gesu
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コンタクト：
- Francesca G Iodice, M.D.
- 電話番号：2449 0039066859
- メール：francesca_iodice@yahoo.it
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主任研究者：
- Francesca Iodice, M.D.
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Rome、イタリア、00195
- 募集
- Francesca Iodice
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コンタクト：
- Francesca Iodice, MD
- 電話番号：393336545045
- メール：fgiovanna.iodice@opbg.net
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コンタクト：
- Francesca Iodice
- 電話番号：393336545045
- メール：francesca_iodice@yahoo.it
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副調査官：
- Giuseppina Testa, MD
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副調査官：
- Vincenzo Vitale, MD
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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:
- Age: 0-18 months
- Mechanical Ventilation via an endotracheal tube
- Elective surgery
- Post-bypass procedure
- Rachs 2 and above
Exclusion Criteria:
- Presence of major congenital malformations
- Presence of neuromuscular disease
- Presence of non drained pneumothorax
- Absent respiratory drive or recurrent apneas
- Hemodynamic instability
- Glasgow coma score (GCS) less than 8
- ECG with evidence of ischaemia or arrhythmias
- Active bleeding
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：並列代入
- 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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他の：High flows
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Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
他の名前：
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
他の名前：
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他の：oxygen therapy
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Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
他の名前：
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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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The primary aim of this study is to show an improvement of the average levels of postextubation PaCO2 in infants less than 18 months of age and post-bypass surgery
時間枠：Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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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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The secondary aim is to verify the reintubation rate between the two groups.
時間枠：Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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Other points that will be evaluated are: the improvement of X-ray findings, the length of ICU stay and the development of complications such as nasal ulcers and gastric distension.
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Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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協力者と研究者
捜査官
- 主任研究者：Francesca Iodice, MD、Ospedale Bambino Gesu'
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)
研究の完了 (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
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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