Comparison of Miller's Blade and Airtraq Laryngoscope in Children
A Comparative Evaluation of Airtraq Optical LaryngoscopeTM and Miller Blade in Pediatric Patients Undergoing Elective Surgery Requiring Tracheal Intubation.
調査の概要
詳細な説明
After approval from the institutional Ethical Committee, 60 patients were studied. A randomised prospective study was planned to compare size 1 Airtraq (Prodol Meditec S.A., Vizcaya, Spain) with Miller blade of same size.
The children included in the study were 2-10 years of age, American Society of Anesthesiologists (ASA) physical status I-II and posted for elective surgeries requiring tracheal intubation. The following were excluded from the study: (i) patients with upper respiratory tract symptoms, (ii) those at risk of gastroesophageal regurgitation and (iii) those with airway-related conditions such a trismus, limited mouth opening, trauma or mass. Sixty patients were equally randomized to one of the two groups (Airtraq and Miller) of 30 each for airway management using a computer-generated randomization program.
Written informed consent was taken from the parents prior to intervention and a standardized protocol for anesthesia was maintained for all cases. All the children were kept nil per mouth as per standard guidelines. Intubation attempts were taken using Airtraq or Miller on a random basis.
研究の種類
入学 (実際)
段階
- 適用できない
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:
- American Society of Anesthesiologists physical status I-II,
- elective surgeries requiring tracheal intubation
Exclusion Criteria:
- patients with upper respiratory tract symptoms,
- those at risk of gastroesophageal regurgitation and
- those with airway-related conditions such a trismus, limited mouth opening, trauma or mass.
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Intubation with Miller's blade
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth.
After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
|
Intubation is insertion of a hollow tube inside the trachea.
It is done after laryngoscopy with Miller's blade.
|
実験的:Intubation with Airtraq laryngoscope
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth.
After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
|
Intubation is insertion of a hollow tube inside the trachea.
It is done after laryngoscopy with Airtraq.
|
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 |
---|---|---|
Time to Intubation
時間枠:5 minutes
|
It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform
|
5 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of Intubation in First Attempts;
時間枠:5 minutes
|
A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.
|
5 minutes
|
Ease of Intubation.
時間枠:5 minutes
|
The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.
|
5 minutes
|
Percentage of Glottic Opening Scoring.
時間枠:5 minutes
|
The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch
|
5 minutes
|
Overall Intubation Success Rate.
時間枠:5 minutes
|
It is the number of participants who were successfully intubated after first, second or third attempts.
Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.
|
5 minutes
|
Number of Esophageal Intubation.
時間枠:5 minutes
|
Insertion of tracheal tube inside the esophagus
|
5 minutes
|
Number of Participants With Airway Trauma
時間枠:5 minutes
|
Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.
|
5 minutes
|
協力者と研究者
捜査官
- スタディディレクター:Shahin N Jamil, M.D.、J.N.Medical College, Aligarh Muslim University
出版物と役立つリンク
一般刊行物
- Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x.
- Sorensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq(R) versus storz(R) videolaryngoscope in children younger than two years - a randomized pilot-study. BMC Anesthesiol. 2012 Apr 30;12:7. doi: 10.1186/1471-2253-12-7.
- White MC, Marsh CJ, Beringer RM, Nolan JA, Choi AY, Medlock KE, Mason DG. A randomised, controlled trial comparing the Airtraq optical laryngoscope with conventional laryngoscopy in infants and children. Anaesthesia. 2012 Mar;67(3):226-31. doi: 10.1111/j.1365-2044.2011.06978.x.
研究記録日
主要日程の研究
研究開始
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 (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
本研究に関する用語
その他の研究ID番号
- DN 182/FM
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