Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children (PEDIAMOVE)
Comparison of Two MOdalities of VEntilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children: a Multicentre Randomised Controlled Trial.
Induction of anesthesia by inhalation is the most common method of induction (70% in France) for young children admitted for non-emergency surgery. It has the advantage of not requiring an intravenous line.
Serious respiratory adverse events such as laryngospasm or bronchospasm remain common in young children during anesthesia induction (approximately 4%) and can reach up to 30% when mild respiratory adverse events (coughing, desaturation < 95%, airway obstruction) are included.
Traditionally, inhalation induction is performed under spontaneous ventilation using the anesthesia ventilator circuit. However, modern ventilators offer the option of applying positive end-expiratory pressure (PEEP) and pressure support ventilation (PSV). Several physiological studies suggest that the use of PEEP + PSV during anesthesia may help maintain airway patency, minute ventilation, and functional residual capacity (FRC).
Our hypothesis is that administering PEEP + PSV at the time of induction may reduce the risk of respiratory complications.
The primary objective is to demonstrate that induction of anesthesia using PEP + PSV, compared with induction of anesthesia under spontaneous ventilation, reduces the risk of adverse respiratory events in children requiring general anesthesia with planned inhalational induction.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Florent Baudin, Pr
- 電話番号：+00334 72 12 97 35
- メール：florent.baudin@chu-lyon.fr
研究連絡先のバックアップ
- 名前：Clarisse Saunier
- 電話番号：+0033427856264
- メール：clarisse.saunier@chu-lyon.fr
研究場所
-
-
-
Lyon、フランス、69677
- Hopital Femme Mere Enfant
-
コンタクト：
- Florent Baudin, Pr
- 電話番号：+00334 72 12 97 35
- メール：florent.baudin@chu-lyon.fr
-
コンタクト：
- Eloise Cercueil, Dr
- 電話番号：+00334 27 85 52 48
- メール：Eloise.cercueil@chu-lyon.fr
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主任研究者：
- Eloise Cercueil, Dr
-
Marseille、フランス、13385
- Hôpitaux Universitaires de Marseille Timone
-
コンタクト：
- Fabrice Michel, Dr
- 電話番号：+334.91.96.47.58
- メール：fabrice.michel@ap-hm.fr
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主任研究者：
- Fabrice Michel, Dr
-
Montpellier、フランス、34295
- Centre hospitalier universitaire de Montpellier
-
コンタクト：
- Chrystelle SOLA, Dr
- 電話番号：(+33)4 67 33 24 48
- メール：c-sola@chu-montpellier.fr
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主任研究者：
- Chrystelle SOLA, Dr
-
Nantes、フランス、44000
- CHU de Nantes
-
コンタクト：
- Jules LECOMTE, Dr
- 電話番号：(+33) 2 40 08 32 50
- メール：jules.lecomte@chu-nantes.fr
-
主任研究者：
- Jules Lecomte, Dr
-
Paris、フランス、75019
- Hopital Robert Debre
-
コンタクト：
- Souhayl DAHMANI, Dr
- 電話番号：(+33)1 40 03 22 21
- メール：souhayl.dahmani@rdb.aphp.fr
-
主任研究者：
- Souhayl DAHMANI, Dr
-
Paris、フランス、75012
- Hôpital Armand Trousseau
-
コンタクト：
- Mireille Nasr, Dr
- 電話番号：+00331 44 73 51 20
- メール：mireille.nasr@aphp.fr
-
主任研究者：
- Mireille Nasr, Dr
-
Reims、フランス、51092
- Centre Hospitalier Universitaire de Reims
-
コンタクト：
- Delphine Michelet, Dr
- 電話番号：(+33)3 26 83 25 37
- メール：dmichelet@chu-reims.fr
-
主任研究者：
- Delpine Michelet, Dr
-
Strasbourg、フランス、67200
- Hôpital de Hautepierre
-
コンタクト：
- Claire BOPP, Dr
- 電話番号：(+33) 3 88 12 61 38
- メール：claire.bopp@chru-strasbourg.fr
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主任研究者：
- Claire BOPP, Dr
-
Toulouse、フランス、31300
- CHU Toulouse - Hôpitaux des enfants
-
コンタクト：
- Delhpine KERN, Dr
- 電話番号：(+33)5 34 55 84 23
- メール：kern.d@chu-toulouse.fr
-
主任研究者：
- Delhpine KERN, Dr
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Child between 3 months and 6 years old
- Without significant comorbidity (ASA 1 or 2)
- Admitted for elective or emergency/urgent surgery under general anesthesia
- With induction of anaesthesia by inhalation by sevoflurane on the machine circuit
- With airway control by intubation tube or supraglottic device
- Consent of at least one parent or legal guardian
Exclusion Criteria:
- Children with severe upper respiratory tract infection (severe moist cough, fever and lethargy, oxygen requirement) in the last 7 days requiring intravenous induction or postpone of the surgery
- Thoracic surgery with selective control of intubation
- Criteria for difficult intubation or known history of difficult intubation
- Children with a contraindication to sevoflurane (ex: risk of malignant hyperthermia)
- Children asking for intravenous induction or requiring rapid sequence induction
- Children with significant cardiac disease (pulmonary hypertension, cyanotic heart disease,…)
- Children not affiliated or beneficiary of a health insurance system
- Children participating in other interventional research with an exclusion period still in progress at inclusion
Exclusion Criteria :
- Failure of venous access after 30 min or more than 5 attempts
- Parents' consent withdrawal
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：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 |
|---|---|
|
実験的：PEEP + PSV
Induction with PEEP (5 cmH2O) and PSV (2-12 cmH2O)
|
Sevoflurane will initially be at 6% (with a fresh gas flow between 2L/min and 10L/min) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation. In the experimental group, the level of PEEP will be set at 5 cmH2O and inspiratory support between 2 and 12 cmH2O and adjusted by the anaesthetist in charge to optimize respiratory mechanics and obtain a physiological tidal volume of 8ml/kg. |
|
他の：Induction in spontaneous breathing
|
Sevoflurane will initially be at 6% (with a fresh gas flow between 2L/min and 10L/min) or increase progressively according to local habits, which can be reduced between 4 and 6% during the installation of the vascular access and increased again to 6% before the control of the airway. The FiO2 will be set at 80% and can be increased up to 100% in case of desaturation. In the control group, there is no PEEP |
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 |
|---|---|---|
|
Number of respiratory adverse events among laryngospasm, bronchospasm, oxygen desaturation, airway obstruction and severe cough
時間枠：Day 0
|
|
Day 0
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of respiratory adverse events among laryngospasm, bronchospasm and oxygen desaturation < 90%.
時間枠：Day 0
|
Risk difference and risk ratio at T4
|
Day 0
|
|
Number of respiratory adverse events among airway obstruction, desaturation < 95% for more than 10s and severe cough
時間枠：Day 0
|
Risk difference and risk ratio at T4
|
Day 0
|
|
Use of oropharyngeal cannula or need for manual ventilation for difficult ventilation.
時間枠：Day 0
|
Risk difference and risk ratio at T4
|
Day 0
|
|
Number of attempts to control the airways
時間枠：Day 0
|
Attempts at tracheal intubation or laryngeal mask insertion, as reported by the physician in charge. Risk difference and risk ratio at T4 |
Day 0
|
|
Number of gastric distension requiring evacuation
時間枠：Day 0
|
Reported by the physician in charge.
Risk difference and risk ratio at T4
|
Day 0
|
|
Pressure support (cmH2O) and tidal volumes (ml/Kg)
時間枠：Day 0
|
Pressure support (cmH2O) set on the ventilator by the physician in charge (continuous variable) Tidal volumes measured on the ventilator by the physician in charge (continuous variable) Relation between the pressure support and the tidal volume at each time T1 and T2 separately |
Day 0
|
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 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 69HCL24_0926
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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