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临床试验/CTRI/2023/03/050930
CTRI/2023/03/050930尚未招募不适用

Evaluation of Incidence of Dysphonia and Vocal Symptoms following Endotracheal Intubation using Praat Software-An Observational Study

Mahatma Gandhi Medical College and Research Institute , Pondicherry1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2023年4月14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
145
试验地点
1
主要终点
Evaluation of Incidence of Dysphonia and Vocal symptoms following Endotracheal Intubation using Praat Software

研究概览

简要总结

Previous studies have already established that there is voice change after endotracheal intubation.Airway management is one of the significant responsibilities of a trained anaesthesiologist.Therefore ,a detailed observational study are required to evaluate the impact on laryngeal function after endotracheal intubation that is vocal acoustic changes on voice and vocal symptoms following endotracheal intubation by using PRAAT software by comparing the voice pre intubation and post extubation voice.

RESEARCH QUESTION : Does Post Endotracheal Intubation cause significant  voice Change and vocal symptoms?

Inclusion criteria will be General Anaesthesia with Endotracheal intubation, patients aged 18 years and above belonging to ASA I-II, and to rule out any preexisting vocal cord lesions.

Exclusion criteria will be Endotracheal intubation during emergency surgery and in ICU, patient with history of preoperative URI or LRI within 14 days of recovery, reactive airway and any surgery that include manipulation of larynx or tracheostomy and past laryngeal surgery, pregnant woman.

The voice of the participants will be recorded and analysed preoperatively by using PRAAT software and will be compared with their voice postoperatively, 2 hours and 24 hours post extubation.

The acoustic analysis of voice will be performed by PRAAT software 6.2.14 version.        The      voice   signal will      be       recorded          with microphone     inbuilt Macbook(laptop)M1 directly with sampling rate of 44100 Hz will be used. Prior to recording, patients will be asked to take a deep breath and to phonate vowels, /a/, /i/, or /u/. The Macbook microphone will be held at a distance of 10 cm from the mouth of the patient with ambient noise below 50 db.

PRAAT software 6.2.14 version will be used to record voice related parameters like Mean pitch (Fundamental frequency), Jitter%, Shimmer(dB), Harmonics to noise ratio (db) and Maximum Phonation time

The vocal symptoms will be evaluated in all patients in the study and it includes Sore throat, hoarseness, vocal fatigue, throat clearing and throat pain.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •1.General anaesthesia with Endotracheal intubation.
  • •2.Patient aged 18 years and above 3.Patient belonging to ASA-1 & ASA-2 4.Rule out Pre existing vocal cord lesions.

排除标准

  • •1.Endotracheal intubation during emergency surgery and in ICU 2.Patient with history of Preoperative URI or LRI within 14 days of recovery .
  • •3.Reactive airway patients , and any surgery that include manipulation of larynx or tracheostomy and past laryngeal surgery.
  • •4.Pregnant Woman.

结局指标

主要结局

Evaluation of Incidence of Dysphonia and Vocal symptoms following Endotracheal Intubation using Praat Software

时间窗: 2 hours and 24 hours after Extubation

次要结局

  • 1. Assessment and evaluation of acoustic vocal indices changes by comparing voice change before intubation and after extubation using PRAAT software.(2. To record the incidence of sore throat ,hoarseness, vocal fatigue ,throat clearing and throat pain following intubation.)

研究者

发起方
Mahatma Gandhi Medical College and Research Institute , Pondicherry
申办方类型
Private medical college

研究点 (1)

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