Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting (AMAC)
In the prehospital setting, the risk of difficult intubation and life-threatening complications is increased under particular conditions due to the environment or the frequent instability of patients.
To limit this risk procedures and devices to ease and secure tracheal intubation must be developped and integrated.
As the prevalence of complications increase with the number of attempts of intubation, one strategy is to facilitate the intubation technic itself.
Direct laryngoscopy with Macintosh blades is the standard device commonly used in first place for tracheal intubation.
Other devices are available and used, mostly for difficult intubation, included videolaryngoscopy. This device has been used and studied for years now. Allowing a better view and glottic visualisation, videolaryngoscopy could increase the first-pass success rate.
Among all videolaryngoscopes, the McGrath videolaryngoscope is the most similar device to the standard Macintosh laryngoscope. It is light, compact, with a screen directly linked to the handle, easy to use and offering excellent view. Its usability and efficacy make it a device of choice for the prehospital setting and worth further clinical trials to define its place in the airway strategy.
Hypothesis: In the prehospital setting, the use of McGrath videolaryngoscope as the primary device for tracheal intubation could facilitate tracheal intubation and decrease the number of attempts of intubation and complications.
The objective of our study is to determine if the use of McGrath videolaryngoscope increase the rate of successful first-pass intubation in the prehospital setting compared to direct view Macintosh laryngoscopy.
The primary outcome is the rate of successful intubation at the first attempt. One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.
Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
調査の概要
状態
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Baudoin Clémence
- 電話番号：+331 49 95 61 61
- メール：clemence.baudoin@aphp.fr
研究連絡先のバックアップ
- 名前：Matthieu Resche-Rigon
- 電話番号：+33142499773
- メール：matthieu.resche-rigon@u-paris.fr
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 more than 18
- Indication of orotracheal intubation
- Operators trained to the use of the McGrath
Exclusion Criteria:
- Pregnancy
- No insurance
- Major patient under guardianship or curatorship
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 |
|---|---|
|
他の：Videolaryngoscopy group
|
Tracheal intubation will be performed using Videolaryngoscope in first intention and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing).
If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
|
|
他の：Direct laryngoscopy group
|
Tracheal intubation will be performed using Direct laryngoscopy with Macintosh blades in first intention.
and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing).
If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
|
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 |
|---|---|---|
|
Rate of successful intubation at the first attempt
時間枠：up to 10 minutes post inclusion
|
One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
|
up to 10 minutes post inclusion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of attempts needed for successful intubation
時間枠：up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Time to intubate
時間枠：up to 10 minutes post inclusion
|
Time to intubate will be defined by the time between the insertion of the device in the mouth and the visualisation of the first waves of EtCO2
|
up to 10 minutes post inclusion
|
|
Reason of failure of the first-pass success
時間枠：up to 10 minutes post inclusion
|
Reasons of failure will be defined as following :
|
up to 10 minutes post inclusion
|
|
Proportion of decision of switch in case of failure
時間枠：up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Proportion of difficult intubations
時間枠：up to 10 minutes post inclusion
|
Difficult intubation will be evaluated by the intubation difficulty score (score IDS or difficulty of intubation under laryngoscopy score ).
It goes from 0 to infinity.
zero indicating an easy intubation and infinity being an impossible intubation
|
up to 10 minutes post inclusion
|
|
Glottic view
時間枠：up to 10 minutes post inclusion
|
Glottic view will be evaluated with Cormack and Lehane grade and POGO score.
POGO score goes from 0 (Visualization of the language base) to 100% (total visualization of the glottis).
Cormack and Lehane grade goes from I to IV.
A higher Cormack and Lehane grade is worth : I indicate total visualization of the glottis and IV indicate Visualization of the language base
|
up to 10 minutes post inclusion
|
|
Proportion of cases who need for tools to optimize
時間枠：up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Proportion of cases needed crossovers to other rescue techniques
時間枠：up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Number of complications per and post-intubation
時間枠：up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Type of complications per and post-intubation
時間枠：up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
|
|
Number of deaths
時間枠：up to 10 minutes post inclusion
|
up to 10 minutes post inclusion
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
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 (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
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