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临床试验/NCT03136549
NCT03136549
已完成
不适用

Cuff Inflation-supplemented Videoscope-guided Nasal Intubation: The Effect of Tube Thermo-softening on the Nasotracheal Navigability

Hallym University Kangnam Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 140 人2017年6月10日

概览

阶段
不适用
干预措施
Room temperature
疾病 / 适应症
Nasotracheal Intubation
发起方
Hallym University Kangnam Sacred Heart Hospital
入组人数
140
试验地点
1
主要终点
severity of epistaxis
状态
已完成
最后更新
3个月前

概览

简要总结

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

注册库
clinicaltrials.gov
开始日期
2017年6月10日
结束日期
2017年12月1日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Hallym University Kangnam Sacred Heart Hospital
责任方
Principal Investigator
主要研究者

Jun joohyun

assistant professor

Hallym University Kangnam Sacred Heart Hospital

入排标准

入选标准

  • 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.

排除标准

  • Patients with bleeding diathesis, history of recurrent nasal obstruction or any nasal/pharyngeal surgery, and those with anticipated difficult tracheal intubation were excluded.

研究组 & 干预措施

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.

干预措施: Room temperature

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).

干预措施: Thermo-softening

结局指标

主要结局

severity of epistaxis

时间窗: 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)

次要结局

  • time(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))
  • the navigation of ET tube from laryngeal inlet to trachea(during navigation from laryngeal inlet to trachea)
  • the navigation of ET tube from nose to oropharynx(during navigation from nose to oropharynx)
  • the navigation of ET tube from oropharynx to laryngeal inlet(during navigation from oropharynx to the laryngeal inlet)
  • air volume(during navigation from oropharynx to laryngeal inlet)

研究点 (1)

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