跳至主要内容
临床试验/CTRI/2025/06/089221
CTRI/2025/06/089221尚未招募不适用

Comparing the effects of endotracheal intubation with video laryngoscope on vocal functions using video-assisted fibreoptic intubation (VAFI), bougie and stylet in adults undergoing general anaesthesia for elective surgeries; three-arm randomized controlled trial

Kalaranjani K1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2025年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
186
试验地点
1
主要终点
Voice analysis measurements including fundamental frequency, jitter, shimmer, harmonic to noise ratio

研究概览

简要总结

During general anaesthesia for surgical procedures, patient’s breathingwill be maintained by fixing an endotracheal tube inside the airway, whichwill be visualized using a laryngoscope. Video laryngoscope is one suchinstrument used for intubating a difficult airway. Various adjuncts can beused as a guide to locate the trachea like bougies and stylets. However,these adjuncts have the disadvantage of limited mobility and flexibility which can result in injury to the larynx. This causes postoperative sore throat, hoarseness of voice and weakness of voice. Video-assisted Fibreoptic Intubation (VAFI) is a newer technique withcombined use of fibreoptic scope and video laryngoscope. Not muchresearch is available on comparison these methods on voice complications in Indian population.This study compares the efficacy of VAFI compared to bougie guidedendotracheal intubation using video laryngoscopy. 

All patients undergoing general anaesthesia will be screened using inclusion criteria like age>18 years, ASA PS 1-II, and normal BMI. Olderpatients, emergency surgeries, critically ill and pregnant patients will beexcluded from the study. Participants will be blinded and divided into 3 groups. After written informed consent, a voice sample will be collected for voice analysis. S/Z ratio and maximum phonation time will be measured. Standard institutional protocol forgeneral anaesthesia will be followed. Intubation will be done using videolaryngoscopy with VAFI, bougie or stylet as adjunct depending on the assignedgroup. Efficacy of the adjuncts will be compared using time taken tointubate, success at first attempt, and number of attempts at intubation. 24hours postoperatively, voice sample will be collected for voice analysis.Patient will be asked to fill out the Voice-Handicap Index (VHI) questionnaire.S/Z ratio and maximum phonation time measurement will be repeated 24 hourspostoperatively.

Data will be collected during the study period of 12 months. Following this,data analysis will be done to identify the superior method in terms of less voice complications, shorter intubation time, higher first attempt success rates,  and lesser number ofattempts. This study would help in choosing a better guide for intubationwhich could be extrapolated for avoiding vocal cord injury. Limitations of thisstudy include performer bias and need for assistant during the procedure.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •Modified Mallampati Grade less than 3 ASA PS 1 and 2 Anticipated duration of procedure less than 2 hours.

排除标准

  • •Age less than 18 years BMI more than 30 kg per m2 Modified Mallampati Grade more than 3 ASA PS more than 3 Duration of the procedure more than 2 hours Emergency surgeries Obstetric surgeries ENT surgeries Critically ill patients Pre-existing voice disorders Chronic smokers.

结局指标

主要结局

Voice analysis measurements including fundamental frequency, jitter, shimmer, harmonic to noise ratio

时间窗: Before intubation and 24 hours after intubation

次要结局

  • Severity of the impact of voice impairment using the Voice-Handicap Index (VHI) questionnaire(24 hours after intubation)
  • S/Z ratio and maximum phonation time (MPT)(Before intubation and 2 hours after intubation)
  • Intubation time(From insertion of video laryngoscopy blade till appearance of EtCO2 curve)
  • Number of intubation attempts(From first time of insertion of guide till successful intubation)
  • First-attempt success rates(From first time of insertion of guide till successful intubation)

研究者

发起方
Kalaranjani K
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验