Comparison of Double Lumen Tube Placement Techniques
2018年6月20日 更新者：Igor Zhukov、Emory University
Comparison of Placement of Double-lumen Endobronchial Tube Using GlideScope With 2 Different Stylet Configurations vs Standard Macintosh Laryngoscopy
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.
調査の概要
状態
終了しました
詳細な説明
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.
The investigators want to evaluate the technique of placement of the double-lumen endobronchial tube (DLT) using an included stylet that has been radically bent (ZU-bend) as compared to a commercial GlideRite stylet with the GlideScope and direct laryngoscopy using the Macintosh laryngoscope.
A double-lumen endobronchial tube (DLT) is a breathing tube utilized to manage the airway when lung separation is needed for a surgical procedure.
The investigator wants to evaluate how long it takes for successful placement of the double-lumen endobronchial tube (DLT) and assess the difficulty of the procedure experienced by the physician performing the intubation.
研究の種類
介入
入学 (実際)
19
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University Hospital
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Atlanta、Georgia、アメリカ、30308
- Emory University Hospital Midtown
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Male and female patients requiring a double-lumen endobronchial tube placement for surgery at Emory University Hospital or Emory University Hospital Midtown
- Patients willing and able to provide written informed consent
Exclusion Criteria:
- Patients in whom a previously difficult airway manipulation was recorded on an anesthetic record
- Lung transplantation procedures, as underlying pulmonary disorder that will confound the SpO2 (peripheral capillary oxygen saturation) metric
- Any patient who is receiving anticoagulants in excess of a daily aspirin, patients with an International Normalized Ratio or INR >1
- Patients in whom one lung ventilation or placement of a double-lumen endobronchial tube is contraindicated
- Patients who require a rapid-sequence intubation
- Patients undergoing emergency procedures
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ヘルスサービス研究
- 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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実験的：ZU-bend stylet with GlideScope technique
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
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Laryngoscopy and intubation after induction of anesthesia will be done using the GlideScope and the ZU-bend stylet.
The ZU-bend is a specific shaping technique of the intubating stylet that is closely related to the GlideScope blade curvature.
Zu-bend stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique.
The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation.
GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
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アクティブコンパレータ：GlideScope with the GlideRite stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
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Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique.
The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation.
GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
Laryngoscopy and intubation after induction of anesthesia will be done with the GlideScope using the GlideRite stylet.
The GlideRite stylet is specifically designed to work with the GlideScope and provides the necessary rigidity and curvature to an otherwise flexible tube.
GlideRite stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
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アクティブコンパレータ：Macintosh blade and a regular DLT stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
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Direct laryngoscopy and intubation after induction of anesthesia will be done with the Macintosh blade and a regular double-lumen endobronchial tube (DLT) stylet.
The Macintosh blade is used to facilitate visualization of the larynx during double or single lumen endobronchial tube placement.
After intubation the Macintosh laryngoscope is removed and the confirmation of the successful placement of the double-lumen endobronchial tube in done in the standard fashion.
他の名前：
Direct laryngoscopy and intubation after induction of anesthesia will be done with a regular double-lumen endobronchial tube (DLT) stylet and the Macintosh blade.
The DLT stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, Macintosh laryngoscope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
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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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Mean Time to Place the Double-lumen Endobronchial Tube
時間枠：during laryngoscope placement, up to 120 seconds
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The time taken for successful intubation will be recorded by the anesthetist.
The total duration from the time the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2), an average of 120 seconds, will be recorded in seconds.
A higher duration noted is indicative of a longer time taken for successful intubation.
0 seconds (laryngoscope at patient's lips), (first End-tidal CO2 (EtCO2) detection)
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during laryngoscope placement, up to 120 seconds
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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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Success Rate of First Endobronchial Intubation Attempt
時間枠：during laryngoscope placement, up to 120 seconds
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The rate of first intubation attempt success will be recorded by the anesthetist.
A successful first attempt intubation is when the double-lumen endobronchial tube is placed during the initial laryngoscopy within 120 seconds.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
Higher numbers of successful first attempt intubations indicate better rates of success of first endobronchial intubation attempts .
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during laryngoscope placement, up to 120 seconds
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Assessment of Difficulty of Intubation
時間枠：during laryngoscope placement, up to 120 seconds
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The ease of successful placement of the double-lumen endobronchial tube (DLT) will be assessed by the anesthetist's responses to a multi-question form which includes the following items that are scored; overall ease of intubation, laryngoscope insertion, glottic view, double-lumen endobronchial tube (DLT) delivery and placement.
The subjective scores range from 0-10; where 0=worst, 10=best.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
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during laryngoscope placement, up to 120 seconds
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Number of Cases With Complications
時間枠：during laryngoscope placement, up to 120 seconds
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Number of cases with complications during intubation will be will be assessed by the anesthetist's responses to a multi-question form which includes the following items; blood on device, SpO2 (peripheral capillary oxygen saturation) <96%, lip and dental trauma and double-lumen endobronchial tube (DLT) cuff rupture.
The responses are recorded as Yes or No for each item.
A 'yes' response indicates a complication.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
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during laryngoscope placement, up to 120 seconds
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Number of Cases of Voice Change
時間枠：Up to 60 minutes after extubation
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Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by asking the patient if any change in voice is experienced (Yes/No).
The subjective answer given by the patient will be recorded.
The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.
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Up to 60 minutes after extubation
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Throat Pain
時間枠：Up to 60 minutes after extubation
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Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by recording the patient's response to the degree of pain experienced.
An analog pain scale will be used for scoring where: 0= no pain and 10= severe pain.
The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.
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Up to 60 minutes after extubation
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Igor Zhukov, MD、Emory University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年7月1日
一次修了 (実際)
2017年7月27日
研究の完了 (実際)
2017年7月27日
試験登録日
最初に提出
2015年7月9日
QC基準を満たした最初の提出物
2015年7月10日
最初の投稿 (見積もり)
2015年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2018年7月27日
QC基準を満たした最後の更新が送信されました
2018年6月20日
最終確認日
2018年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB00081067
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。