Does a Customized Intubation Facility Reduce Incidence of Difficulty (Person-OTI)
Does a Customized Intubation Facility Reduce Incidence of Difficulty: Randomized Multicenter Trial?
The idea of this study is to demonstrate that the position of the head at a comfort height spontaneously expressed by the patient, between Jackson's amended position or Ramp position, significantly improves the quality of the intubation gesture. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress.
Thus the investigators can assume that the appropriate positioning and use of a video laryngoscope (McGrathR Mac) places the patient in the best anatomical configuration to breathe and, indirectly to facilitate control of the airways, especially for those with a risk of difficult airway management.
調査の概要
詳細な説明
Position for orotracheal intubation The period preceding the administration of anesthetic agents is essential to ensure a satisfactory oxygen supply (pre-oxygenation). Then, once loss of consciousness is achieved, an interface (oral intubation probe) is put in place to allow mechanical ventilation during the procedure. This phase can be marked by a more or less expected difficulty depending on the risk factors presented by the patient. Thus an Arne score> 11 is predictive of a potential difficulty which may lead to an alternative technique being proposed. Simple techniques also exist in the patient setup to reduce the incidence of difficulties. Among them, the placement of a cushion under the head with a slight extension of the head of 20 ° (Jackson's amended position) is recommended because it allows to obtain the alignment of the posterior pharyngeal and glottic spaces. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress.
This optimization of the position according to the patient, between Jackson's amended position or Ramp position, opens up the prospect of defining an optimal position personalized to each patient. Thus, it can be assumed that the appropriate positioning places the patient in the best anatomical configuration for breathing and, indirectly, to facilitate control of the airways.
- Video laryngoscope The use of a video laryngoscope (McGrathR Mac) is becoming widespread in anesthesia, especially for the management of patients at risk of difficult airway management. This device by the video support at the end of the blade provides a better visualization of the glottic orifice.
- The hypothesis of this research The idea of this study is to demonstrate that the position of the head at a height of comfort spontaneously expressed by the patient significantly improves the quality of the intubation procedure.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Suresnes、フランス、92150
- Morgan LE GUEN, PhD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Men or women over 18 and under 80;
- Must undergo general anesthesia with oral intubation using a standard intubation probe;
- Can be contacted directly by telephone if they are patients treated in outpatient surgery;
- Having signed a consent form;
- Being affiliated to a Health Insurance scheme.
Exclusion Criteria:
- pregnant or breastfeeding patients;
- patients with a predicted difficulty in mask ventilation or intubation according to the assessment of the doctor who performs the clinical examination prior to inclusion (Arne score ≥ 11) or the one who takes care of the patient in the block operative;
- patients for whom the surgery requires the placement of a double-lumen tube;
- patients requiring rapid sequence induction;
- patients for whom induction cannot be carried out by the sufentanil, propofol, atracurium or rocuronium sequence.
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 |
|---|---|
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実験的：Custom
patient with installation on an infused airbag until a comfortable position is reached
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patient with personalized installation until a comfortable position is reached
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介入なし：Control
Jackson's amended position with placement of a 6 cm high cushion under the patient's head
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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the impact of a custom installation versus a conventional Jackson amended installation with a 6-centimeter cushion under the patient's head to facilitate orotracheal intubation
時間枠：1 day
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the proportion of orotracheal intubations for which third party assistance is required
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1 day
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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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Assessment of the effect of patient positioning on the quality of exposure during intubation
時間枠：1 day
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1 day
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Determination of the most frequent complementary resettlement actions
時間枠：1 day
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1 day
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Assessment of the quality of manual ventilation before intubation (peroxygenation)
時間枠：1 day
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1 day
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Assessment of the frequency and severity of complications of intubation
時間枠：2 days
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The complications of intubation was defined by the pharyngeal pain the day after surgery, dysphonia, an irritative cough reported by the patient and atelectasis.
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2 days
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Assessment of patient comfort and the doctor's opinion on the technique
時間枠：1 day
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The doctor's opinion on the technique was defined by the regard to pre-oxygenation, peroxygenation, and intubation.
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1 day
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Safety assessment of the technique
時間枠：1 day
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Safety was evaluated by the occurrence of a fall of the head, occurrence of a fall of the patient, accidental extubation, the incidence of arterial oxygen desaturation, the lowest arterial oxygen saturation and the perception of difficulty in intubation.
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1 day
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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 (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
その他の研究ID番号
- 2020_0030
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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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