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临床试验/NCT01099969
NCT01099969已完成不适用

Endotrol-tracheal Tube Assisted Endotracheal Intubation During Video Laryngoscopy

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Number of Difficult Intubations

研究概览

简要总结

The purpose of this study is to compare the safety and efficacy of Endotrol Tube compared to the conventional endotracheal tube in conjunction with the GlideRite stylet (Verathon Medical Inc, USA) during videolaryngoscopy assisted endotracheal intubation using a McGrath (Aircraft Medical Ltd., and distributed in the US by LMA North America, Inc.) video laryngoscope or a GlideScope (Verathon Medical Inc, USA). The investigators hypothesize that using the Endotrol tracheal tube, (Covidien, Colorado, USA) is safer and more efficacious than using the conventional endotracheal tube during McGrath video laryngoscope and/or GlideScope aided endotracheal intubation.

详细描述

It is estimated that endotracheal intubation is performed on some 8 million patients per year in the United States. Of these endotracheal intubations, approximately 80% are performed by direct laryngoscopy with transoral placement of the endotracheal tube (ET) into the trachea. There is fairly uniform reporting of the incidence of failed intubation in the literature; it occurs in approximately 0.05% or 1:2230 of surgical patients and in approximately 0.13% to 0.35%, or 1:750 to 1:280, of the obstetric patients.1,2 The incidence of unsuspected difficult intubation is estimated to be higher at 3%. One factor that contributes to difficult intubation is poor visualization of the airway. Video laryngoscopes are a relatively new edition to the armamentarium of airway devices available to the airway manager. Although these instruments are more expensive than traditional direct laryngoscopes, they offer several advantages that may justify their expense. Although some clinicians may espouse the routine use of video laryngoscopy, most providers reserve it for anticipated difficult situations or as "plan B" after failed intubation by direct laryngoscopy (DL). There are several advantages of a video intubation technique as compared to direct laryngoscopy. The video laryngoscopes have been shown to provide superior views to traditional laryngoscopy as well as in difficult intubations.3-5 Video intubation techniques, by allowing tracheal intubation monitoring, have been shown to improve the safety of the procedure and increase intubation success. The GlideScope consists of a digital camera, called a video baton, which fits into a plastic laryngoscope blade and a light source on the side to provide a video image of airway structures on a screen, which can be conveniently located directly in front of the anesthesiologist. The GlideRite rigid stylet conforms to the GlideScope blade angulation, which,eliminates the need to manually shape the stylet to fit down the airway and improves maneuverability in endotracheal tube placement.

It should be noted that several reports have been published describing trauma to the upper airway (anterior tonsillar pillar, soft palate) during intubation with video laryngoscopes. Recently, several reports using endoflex tube (which is similar to the endotrol tube) showed that there is considerable usefulness in normal direct laryngoscopy and video laryngoscopy (using glidescope) as well. The purpose of this study is to compare the safety and efficacy of Endotrol Tube (Covidien, Colorado, USA) compared to the conventional endotracheal tube in conjunction with the GlideRite stylet during videolaryngoscopy assisted endotracheal intubation.

INSTRUMENTS:

McGrath Video Laryngoscope (MVL) - A video-based system for tracheal intubation that utilizes a video camera embedded into a "camera stick". The resulting video image is displayed on a small color Liquid Crystal Display (LCD) attached to the top of the handle of the device, which can be adjusted to obtain the best view. The unit is powered with a single easily-replaced AA battery and features a single electronic control: an on/off switch located on the top of the unit. The device is available with an adjustable curved MAC blade (sizes 3 to 5). Also,the device features a sterile disposable transparent blade sheath preventing cross infection.

GlideScope Video Laryngoscope (GVL)- The GlideScope was commercially introduced in 2001. The 1- piece handle and blade is made of medical- grade plastic. It has a vertical profile of 14.5 mm, a midblade bend of 50-60 degrees, and a video camera with a light-emitting diode housed toward the distal end of the blade. The image captured by the camera is transferred by the attached cable to a color liquid crystal display (LCD). A heating element covers the camera lens and ensures effective antifogging after the device has been turned on for 15- 30 seconds. The blades can be sterilized and reused, and are available in 3 sizes: large (adult), midsize (pediatric), and small (neonatal). As the image is transferred to the LCD display, anesthesiologists are able to view key anatomical landmarks at the earliest possible time, facilitating navigation. Also, in cases requiring external laryngeal manipulation, the assistant can see the effect of the maneuver on the monitor simultaneously with the anesthesiologist for quicker, more efficient intubation. Endotrol Tracheal Tube (ETT) (Covidien, Colorado, USA) - A sterile, single lumen, disposable ET with a built- in flexing mechanism with a standard 15 mm connector. The tube provides directional tip control via an operator- activated ring loop and incorporates a self- sealing valve with attached pilot balloon. The ETT is specifically designed for use in cases where difficult intubation can be aided with directional tip control. Due to the Hi-Lo cuff design, the ETT is acceptable for oral/nasal intubation of the trachea for anesthesia and in cases where the intubation duration is expected to be more than 24 hours or unpredictable. The special way to hold the ETT is to place the thumb of the right hand against the end of the 15 mm connector and the index finger in the ring loop. Pulling on the ring loop causes the tip to turn anteriorly towards the tracheal opening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-80 years old
  • ASA: I-III
  • Mallampati: I-III
  • Mouthopening: 2 FB or < 4 cm

排除标准

  • Age < 18 years or > 80 years
  • Mallampati: IV
  • Mouthopening < 2 FB 4cm
  • No risk for aspiration
  • No respiratory infection in past 10 days

研究组 & 干预措施

Glidescope with non-styletted Endotrol ETT

Experimental

The patients in this arm will be intubated using a Glidescope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).

干预措施: Glidescope videolaryngoscope (Device)

Glidescope with non-styletted Endotrol ETT

Experimental

The patients in this arm will be intubated using a Glidescope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).

干预措施: Non-styletted Endotrol endotracheal tube (ETT) (Device)

Glidescope with styletted regular ETT

Active Comparator

The patientsin this arm will be intubated using the glidescope videolaryngoscope and regular endotracheal tube (ETT) with gliderite stylet.

干预措施: Glidescope videolaryngoscope (Device)

Glidescope with styletted regular ETT

Active Comparator

The patientsin this arm will be intubated using the glidescope videolaryngoscope and regular endotracheal tube (ETT) with gliderite stylet.

干预措施: Regular endotracheal tube (ETT) with Gliderite stylet (Device)

McGrath with non-styletted Endotrol ETT

Experimental

The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).

干预措施: McGrath videolaryngoscope (Device)

McGrath with non-styletted Endotrol ETT

Experimental

The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).

干预措施: Non-styletted Endotrol endotracheal tube (ETT) (Device)

McGrath with with styletted regular ETT

Active Comparator

The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with Gliderite stylet.

干预措施: McGrath videolaryngoscope (Device)

McGrath with with styletted regular ETT

Active Comparator

The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with Gliderite stylet.

干预措施: Regular endotracheal tube (ETT) with Gliderite stylet (Device)

结局指标

主要结局

Number of Difficult Intubations

时间窗: at the time of placement of the endotracheal tube

Ease of intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = extremely difficult). A score of 4 or 5 was characterized as "difficult."

Intubation Time

时间窗: time from insertion of the laryngoscope to detection of CO2 on the capnogram

Intubation time is the time from insertion of the laryngoscope to detection of CO2 on the capnogram.

Number of Intubation Attempts

时间窗: at the time of placement of the endotracheal tube

次要结局

  • Cormack and Lehane Grade of Laryngeal View(at the time of intubation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Davide Cattano

Associate Professor - Anesthesiology

The University of Texas Health Science Center, Houston

研究点 (2)

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