Hemodynamic Responses of Different Laryngoscopes
Comparison of Different Laryngoscopes in Terms of Hemodynamic Responses
During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and techniques have recently started to be used.
In this randomized single blind study, the aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.
調査の概要
状態
詳細な説明
During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and methods have recently started to be used.
In this randomized single blind study, our aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.
After obtaining Institutional Ethics Committee approval and patient consents, 170 patients (18-65 years old) with ASA I-II status requiring general anesthesia with endotracheal intubation, were enrolled to this prospective randomized study.
Besides routine monitorization (noninvasive blood pressure (NIBP), electrocardiography (ECG), heart rate (HR), peripheral oxygen saturation (SPO2)), continuous BIS monitorization was also performed. Sedation was performed using a standard dose of IV fentanyl (1.5 μg/kg) and midazolam (0.05 mg/kg). Baseline systolic, diastolic and mean arterial blood pressures, HR and SPO2 values were recorded as T0. After a stabilization period of 10 minutes, propofol 2-3 mg/kg IV bolus was applied incrementally until a clinically desirable sedation level was achieved. If necessary, additional propofol boluses were given to maintain a BIS level of 60. As soon as BIS level was reduced to 60, patients were put on 0.6 mg/kg IV rocuronium. 100% oxygen was applied with a facemask for a period of 3 minutes. Then, post induction values (T1) were recorded.
One hundred seventy patients were randomly allocated equally to Macintosh laryngoscope, Mc-Coy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope groups. Endotracheal tube (ETT) of 7.0 mm and 7.5 mm were placed to female and male patients, respectively. All intubation procedures were performed by a single experienced anesthesiologist. Intubation stylet was provided, if necessary. Cuff pressures of endotracheal tubes were standartized to 30 cmH2O via a manometer. The following measurements were recorded immediately after intubation (T2) and at one minute intervals for 5 minutes (T3, T4, T5, T6 and T7).
Moreover; the number of intubation attempts, stylet needs, Cormack-Lehane scales, and the complications occurred during intubation procedures were recorded as the second outcomes. Patients were also questioned for possible sore throat at postoperative 2 hours. Patients requiring more than one attempt to achieve successful intubation were excluded from statistical analysis of data.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Istanbul、七面鳥、34093
- Istanbul University, Department of anesthesiology
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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:
- Patients with ASA I-II status, requiring general anesthesia with endotracheal intubation
Exclusion Criteria:
- ASA status higher than II, a history or suspected of difficult airway, hypertansion, under treatment known to affect blood pressure or heart rate (Beta blocker/ Ca-channel blocker), BIS value > 60
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:ふるい分け
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Macintosh laryngoscope
Endotracheal intubation with classic (Macintosh) laryngoscope
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Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)
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アクティブコンパレータ:Mc-Coy laryngoscope
Endotracheal intubation with Mc-Coy laryngoscope
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Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope
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|
アクティブコンパレータ:C-Mac videolaryngoscope
Endotracheal intubation with C-Mac videolaryngoscope
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Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
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アクティブコンパレータ:McGrath videolaryngoscope
Endotracheal intubation with McGrath videolaryngoscope
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Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope
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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 |
|---|---|---|
|
Arterial blood pressure
時間枠:Change from baseline in blood pressures at first 20 minutes
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Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded during and after induction
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Change from baseline in blood pressures at first 20 minutes
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Heart rate
時間枠:Change from baseline in heart rates at first 20 minutes
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Hemodynamic parameters as heart rates were recorded during and after induction
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Change from baseline in heart rates at first 20 minutes
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SPO2 value
時間枠:Change from baseline in SPO2 values at first 20 minutes
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Hemodynamic parameters as SPO2 values were recorded during and after induction
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Change from baseline in SPO2 values at first 20 minutes
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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 |
|---|---|---|
|
Number of intubation attempts
時間枠:During endotracheal intubation
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Number of intubation attempts were recorded
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During endotracheal intubation
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Stylet need
時間枠:During endotracheal intubation
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Stylet need was recorded
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During endotracheal intubation
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Cormach-Lehane scales
時間枠:During endotracheal intubation
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Cormack-Lehane scales were recorded
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During endotracheal intubation
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Complications
時間枠:During endotracheal intubation
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Possible complications were recorded
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During endotracheal intubation
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Sore throat
時間枠:Postoperative 2 hours
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Possible sore throat was recorded
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Postoperative 2 hours
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Demet Altun, MD、Istanbul University, Department of Anesthesiology an Reanimation
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
- 2014/1191
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。
Macintosh laryngoscopeの臨床試験
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AnestesiaRわからない
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Cairo UniversityPrince Sultan Cardiac Center, Adult Cardiology Department.まだ募集していません
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Hitit UniversityIzmir City Hospital完了