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临床试验/CTRI/2024/03/064685
CTRI/2024/03/064685已完成不适用

A randomized controlled, comparative study of intubation success rate between channeled Vs non channeled blade of Hugmed videolaryngoscope for orotracheal intubation.

Seth GSMC and KEMH1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年4月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Comparison between the channeled and non-channeled blade of

研究概览

简要总结

Laryngoscopy and endotracheal intubation play an important role in airway management for anaesthesiologists. Video laryngoscope may provide indirect glottis view without the need of alignment of oropharyngeal-laryngeal axis. It may reduce the number of failed intubations, particularly in patients with difficult airway.

This randomized comparative study was conducted in the general surgery operating theatre of a tertiary care center. Following approval from the institutional ethics committee and after obtaining written informed consent, a total of 80 patients scheduled for elective general surgical procedures requiring endotracheal intubation under general anaesthesia were enrolled. Participants fulfilling inclusion criteria were randomly assigned into two groups-patient intubated with channeled blade and patient intubated with non channeled of hugmed video laryngoscope—using computer-generated table.

The primary objective of the study was comparison between the channeled and non-channeled blade of Hugmed video laryngoscopes with respect to rate of successful intubation in first attempt. Parameters assessed included time-for-visualization of glottis(T1), time till black line of ET tube beyond cord (T2), time till confirmation by capnography(T3), numbers of attempts for orotracheal intubation, POGO Score (percentage of glottis opening score), impingement and manipulation of ETT, Use of other adjuncts – bougie and complications due to intubation.

Demographics and airway characteristics were well matched for chnneled and non channeled group, with no statistically significant differences in age, gender, height, weight, ASA grade, mouth opening, neck movement, or Modified Mallampati Classification (all p > 0.05). This comparability between groups ensured that observed outcomes were not confounded by demographic or anatomical differences.

The number of attempts required for successful intubation in all patients (100%) in the channeled group were successfully intubated on the first attempt, while 97.5% of the non channeled group were intubated on the first attempt, with only one patient (2.5%) requiring a second attempt. The difference between the groups was not statistically significant (p = 1.000), indicating that both techniques were comparably effective in achieving first-attempt intubation success.

The time to glottis visualization (T1) between the channeled group had a significantly longer mean T1 of 13.82 seconds, compared to 8.18 seconds in the non-channeled group. The difference was statistically significant (p < 0.0001), suggesting that glottis visualization was achieved more rapidly using the non-channeled technique. This implies better manoeuvrability or visualization efficiency with the non-channeled video laryngoscope blade. The time taken for the endotracheal tube (ETT) to pass beyond the vocal cords (T2) is the channeled group showed a significantly shorter mean time of 7.18 seconds, while the non channeled group required a substantially longer mean time of 16.80 seconds. This difference is highly statistically significant (p < 0.0001). These results indicate that the channeled video laryngoscope facilitated quicker advancement of the ETT beyond the vocal cords compared to the non-channeled blade.

The time for capnography confirmation (T3) showed channeled group demonstrated a significantly shorter mean time of 9.57 seconds, while the non-channeled group required a mean time of 11.65 seconds. The observed difference is highly statistically significant (p < 0.0001). This indicates that channeled blades allowed for faster confirmation of successful intubation via capnography, likely due to easier navigation and tube placement.

The POGO score for channeled group is 100.00%, indicating full visualization of the glottic opening in all cases. In contrast, the non-channeled group had a slightly lower mean POGO score of 96.88%, Although the difference approaches statistical significance (p = 0.0541), it 77 does not meet the conventional threshold of 0.05, suggesting a trend toward better glottic visualization with the channeled blade, but not conclusively so.

In our study, intubation with the channeled blade required significantly fewer manipulations overall, with adjustments needed in 55% of cases compared to 12.5% in the non-channeled group (p = 0.00015) indicating smoother intubation with the channeled blade. Impingement over the epiglottis was more frequent with the non-channeled blade (20.0%) and absent in the channeled group (p = 0.0053). Withdrawal and redirection of the tube toward the midline occurred more often with the non-channeled blade (17.5% vs. 0%, p = 0.0647), while anticlockwise tube rotation was occasionally required in the channeled group (10%), without a significant difference between groups. The BURP manoeuvre was rarely needed in either group, with no significant difference. Overall, the channeled blade demonstrated smoother intubation with fewer corrective manoeuvres.

Bougie was used in 7.5% of non-channeled cases and in none of the channeled cases. The difference was not statistically significant (p = 0.239), indicating that adjunct usage was slightly higher in the non-channeled group, but the variation may be due to chance. Notably, sore throat occurred exclusively in 15% of non-channeled cases due to impingement of endotracheal tube, while lip bleeding was observed only in 10% of channeled cases due to bulky blade of channeled blade. The difference in overall complication rates was statistically significant (p = 0.0065), suggesting a meaningful variation in complication profiles between the two groups, potentially influenced by blade type.

Both the channeled and non-channeled video laryngoscope blades achieved a high first-attempt intubation success rate. The channeled video laryngoscope required less time for advancement of the endotracheal tube (EET) beyond the vocal cords, fewer optimization maneuvers, and was associated with a lower incidence of complications, highlighting its practical advantages in routine airway management. The non-channeled blade offered faster glottic visualization, had a smaller blade size, and aligned with certain operator preferences. 78 However, its limitations included a longer time for the endotracheal tube to pass beyond the cords, and a greater need for additional manoeuvres to achieve successful intubation and complication during intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient of either sex of age group 18-60yr 2.Undergoing elective surgery under General anaesthesia with endotracheal intubation
  • ASA I and II.

排除标准

  • Patient with difficult airway- mouth opening less than 2, restricted neck extension, neck swelling.
  • Emergency surgery 3.Increase risk of gastric content, regurgitation or aspiration.

结局指标

主要结局

Comparison between the channeled and non-channeled blade of

时间窗: Comparison between the channeled and non-channeled blade of | Hugmed video laryngoscopes with respect to rate of successful | intubation in first attempt.

Hugmed video laryngoscopes with respect to rate of successful

时间窗: Comparison between the channeled and non-channeled blade of | Hugmed video laryngoscopes with respect to rate of successful | intubation in first attempt.

intubation in first attempt.

时间窗: Comparison between the channeled and non-channeled blade of | Hugmed video laryngoscopes with respect to rate of successful | intubation in first attempt.

次要结局

  • Secondary outcome includes:(1. Time-for-visualization of glottis)

研究者

发起方
Seth GSMC and KEMH
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Priti Devalkar

Seth G S medical College Parel Mumbai

研究点 (1)

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