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临床试验/CTRI/2022/10/046854
CTRI/2022/10/046854尚未招募不适用

Comparison of intubation characteristics of King Vision video laryngoscope vs C-Mac video laryngoscope for nasotracheal intubation- A randomised controlled study

Jerome Kumar R1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2022年1月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
86
试验地点
1
主要终点
Time taken for nasotracheal intubation

研究概览

简要总结

COMPARISON OF INTUBATION CHARACTERISTICSOF KING VISION VIDEO LARYNGOSCOPE VS C-MAC VIDEOLARYNGOSCOPE FOR NASOTRACHEALINTUBATION – A RANDOMISED CONTROLLED STUDY

Nasotrachealintubation is essential to provide surgical access in patients who areundergoing oral and maxillofacial surgeries. Nasotracheal intubation is morechallenging than orotracheal intubation due to the difficulty in advancing thetip of the endotracheal tube into the trachea.Video laryngoscopes aid invisualisation of the vocal cords without the need to align the oral, pharyngeal, and tracheal axes hence facilitating intubation. This study will be done tocompare C-MAC D-blade video laryngoscope to non-channelled King Vision videolaryngoscope for nasotracheal intubation. This study will include 86 ASA -1 and ASA-2 patients agedbetween 18 to 59 years undergoing maxillofacial or oral cavity surgeryrequiring nasotracheal intubation. Patients will be divided into 2 groups (43 each) randomly via computer generated sequence. A detailedpreanesthetic evaluation and all the relevant investigations will be done. On arrival in OT,standard ASA monitors will be attached and all patients will bepremedicated using 0.02 mg/kg midazolam, 0.2mg glycopyrrolate, 4mg ondansetron and2mcg/kg fentanyl intravenously. Allthe patients will be preoxygenated with 100% oxygen for 3 minutes. Standard induction will bewith Inj. Propofol 1.5-2mg/kg intravenously and Inj. Atracurium 0.5 mg/kgintravenously for muscle relaxation. Isoflurane will be used as theinhalational agent. Nasotracheal intubation will be performed withappropriately sized RAE(Ring-Adair-Elwin) endotracheal tube by an experienced anaesthesiologist.The primary outcome variable will be total intubation time calculated from the beginning of introduction ofthe RAE endotracheal tube in the nostril till the appearance of the first end‑tidalcarbon dioxide waveform(capnography). This willinclude time required for insertion of the ETT in each of three intubation steps(from nose into oropharynx(T1), from oropharynx into glottic inlet(T2), andfrom glottic inlet to observation of first capnographic trace(T3)). The timetaken will be noted by the Primary investigator using a stopwatch. Thesecondary outcomes will be comparingglottic view as percentageof glottis opening (POGO) score, modified nasal intubation difficulty score (NIDS) and complications related to NTI. Datacollected will be collected and will be tabulated for statisticalanalysis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists physical status(ASA) grade 1 and 2 patients scheduled for elective or emergency maxillofacial or oral cavity surgeries requiring nasotracheal intubation.

排除标准

  • 1.Anticipated difficult endotracheal intubation (Mallampati score IV and thyromental distance of ≤6.0cm) 2.Coagulopathy 3.A history of nasal deformity, obstructive sleep apnoea, recurrent epistaxis, nasopharyngeal abnormality or surgery 4.Severe obesity (body mass index [BMI] ≥35kg/m2) 5.Cervical spine instability/pathology or cervical myelopathy 6.Pregnancy 7.Neck mass 8.Gastro oesophageal reflux disease.

结局指标

主要结局

Time taken for nasotracheal intubation

时间窗: T1–Time taken to pass endotracheal tube from nose into oropharynx | T2–Time taken to pass endotracheal tube from oropharynx into glottic inlet | T3–Time taken to pass endotracheal tube from glottic inlet to observation of first capnographic trace

次要结局

  • Glottic view as percentage of glottis opening (POGO) score(At the time of laryngoscopy)
  • Modified nasal intubation-difficulty scale (NIDS) rating(At the time of laryngoscopy)
  • Complications in the two groups(At the time of glottic visualization,)

研究者

发起方
Jerome Kumar R
申办方类型
Other [self]

研究点 (1)

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