Comparison of Double Lumen Tube Placement Techniques
20 июня 2018 г. обновлено: 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.
Обзор исследования
Статус
Прекращено
Условия
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
19
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30322
- Emory University Hospital
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Atlanta, Georgia, Соединенные Штаты, 30308
- Emory University Hospital Midtown
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Активный компаратор: 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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Активный компаратор: 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.
Другие имена:
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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Mean Time to Place the Double-lumen Endobronchial Tube
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Success Rate of First Endobronchial Intubation Attempt
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Igor Zhukov, MD, Emory University
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 июля 2015 г.
Первичное завершение (Действительный)
27 июля 2017 г.
Завершение исследования (Действительный)
27 июля 2017 г.
Даты регистрации исследования
Первый отправленный
9 июля 2015 г.
Впервые представлено, что соответствует критериям контроля качества
10 июля 2015 г.
Первый опубликованный (Оценивать)
13 июля 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
27 июля 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
20 июня 2018 г.
Последняя проверка
1 июня 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- IRB00081067
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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