Cuff Inflation-supplemented Videoscope-guided Nasal Intubation
Cuff Inflation-supplemented Videoscope-guided Nasal Intubation: The Effect of Tube Thermo-softening on the Nasotracheal Navigability
Epistaxis or post-pharyngeal bleeding is the most common complication after nasotracheal intubation (NTI). Prior thermal softening of the endotracheal tube (ET) has been recommended as one of the methods to prevent nasal trauma from nasotracheal intubation. However, thermal softening of tubes tends to adversely affect the nasotracheal navigation of the ET.
During NTI under conventional direct laryngoscopy, the tip of the Macintosh laryngoscope is advanced into the vallecula, indirectly elevating the epiglottis by applying pressure on the hyoepiglottic ligament. Although this maneuver allows optimal visualization of the glottis, it lifts the larynx away from the tip of the advancing nasotracheal tube (NTT), which generally lies along the posterior pharyngeal wall. Most clinicians use Magill forceps to direct the tip of the NTT anteriorly to enter the glottis. Magill forceps may cause damage to the cuff of an ET or may injure oropharyngeal mucosa.
The use of a video laryngoscope and a cuff inflation technique has been proposed as a method for reducing the malalignment of tubes. Indirect laryngoscopy using a Video laryngoscopy can reduce malalignment by minimizing lifting the glottis during laryngoscopy. The cuff inflation technique (wherein the cuff of ET tube is inflated with 15 mL of air) has been used while performing "blind" NTI to guide such malaligned polyvinyl chloride (PVC) ET tubes into the laryngeal inlet. Recently, one study reported that the cuff inflation technique consistently improved the oropharyngeal insertion of the different ET tubes of varying stiffness during direct laryngoscope-guided NTI.
There has never been study about effect of cuff inflation technique on navigability when performing NTI under video laryngoscopy guidance with ET tubes of varying stiffness.Investigators assessed and compared the incidence of nasal injury and nasotracheal navigability with two technique during cuff inflation-supplemented NTI guided by video- laryngoscopy
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Joohyun Jun, MD
- 电话号码：82-2-829-5240
- 邮箱：ilpleut@naver.com
学习地点
-
-
-
Seoul、大韩民国
- 招聘中
- Kangnam Sacred Heart Hospital, Hallym University College of Medicine
-
接触：
- Joohyun Jun, MD
- 电话号码：+82-2-829-5240
- 邮箱：ilpleut@naver.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ASA status I-III, older than 18 yr, who under went elective surgery and requiring ET intubation as part of anesthetic management were enrolled in the study.
Exclusion Criteria:
- Patients with bleeding diathesis, history of recurrent nasal obstruction or any nasal/pharyngeal surgery, and those with anticipated difficult tracheal intubation were excluded.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Room temperature
The nasotracheal tube, sized 6.0 -7.0 mm inner diameter (ID), were put into a bottle of sterilized normal saline (1 L, 25 °C) at room temperature.
|
nasotracheal tube, sized 6.0 -7.0 mm inner diameter (ID), were put into a bottle of sterilized normal saline (1 L, 25 °C) at room temperature.
|
|
实验性的：Thermo-softening
The naso tracheal tube, sized 6.0 -7.0 mm inner diameter (ID), were put into a bottle of sterilized normal saline (1 L) at warm cabinet set to 45°C (approximately 117°F).
|
The thermosoftening treatment of the tubes was performed by using a warm cabinet set to 45°C (approximately 117°F).
One bottle of normal saline (1 L) containing a thermometer and three tubes (6.0 -7.0 mm ID) was put into a chamber of the cabinet 30 min before intubation.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
severity of epistaxis
大体时间：during navigation from nose to oropharynx
|
The severity of epistaxis was evaluated under VL using a 4-point scale:no epistaxis; mild epistaxis (blood on the tracheal tube only); moderate epistaxis (blood pooling in the pharynx); or severe epistaxis (blood in the pharynx sufficient to impede intubation)
|
during navigation from nose to oropharynx
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the navigation of ET tube from nose to oropharynx
大体时间：during navigation from nose to oropharynx
|
The navigability (ease of insertion) was scored as grade 1 if the tube advanced smoothly from the nose into oropharynx, grade 2 if there was resistance in the passage that could be managed by side-to-side rotation of the tube, and grade 3 if the tube impinged unduly and the other nostril had to be used.
|
during navigation from nose to oropharynx
|
|
time
大体时间：The passage of each ET tube from nasal cavity to trachea was divided into 3 phases (phase 1: from the nose into oropharynx, phase 2: from oropharynx into the laryngeal inlet , phase 3: from the laryngeal inlet into the trachea)
|
time required for passage of tube in each phase
|
The passage of each ET tube from nasal cavity to trachea was divided into 3 phases (phase 1: from the nose into oropharynx, phase 2: from oropharynx into the laryngeal inlet , phase 3: from the laryngeal inlet into the trachea)
|
|
air volume
大体时间：during navigation from oropharynx to laryngeal inlet
|
the volume of air needed for cuff inflation during navigation from oropharynx to laryngeal inlet
|
during navigation from oropharynx to laryngeal inlet
|
|
the navigation of ET tube from oropharynx to laryngeal inlet
大体时间：during navigation from oropharynx to the laryngeal inlet
|
The tube was then advanced further from oropharynx into the laryngeal inlet under video laryngoscopic vision, and a smooth passage was scored as grade 1.
In case the tube failed to align with the laryngeal inlet, the tube tip was withdrawn into the laryngopharynx and the cuff of the tube was sequentially inflated with air in 4 mL aliquots up to a maximal volume of 40 mL by an assistant on request until it aligned with the laryngeal inlet (cuff inflation technique) and got engaged in it thereafter (grade 2).
If this technique was unsuccessful, the cuff was deflated and Magill forceps were used to engage the tube tip into the laryngeal inlet (grade 3).
|
during navigation from oropharynx to the laryngeal inlet
|
|
the navigation of ET tube from laryngeal inlet to trachea
大体时间：during navigation from laryngeal inlet to trachea
|
A smooth passage was considered grade 1.
If the ET tube tip got stuck in the laryngeal vestibule, optimal external laryngeal manipulation (OELM) applied (grade2); If the ET tube tip got stuck in the laryngeal vestibule, it was rotated clockwise while maintaining a gentle forward pressure on it until it got disengaged from its impingement and then slipped into the trachea (grade 3).
In case this maneuver was unsuccessful, Magill forceps were used to complete the intubation process (grade 4).
|
during navigation from laryngeal inlet to trachea
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2017-03-020
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.