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临床试验/NCT04011111
NCT04011111已完成不适用

Objective and Subjective Evaluations of the Effect of Different Types of Intubation Tube Applications on Voice Performance in Early Postoperative Period

Hitit University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
F0 (Fundemental frequency)

研究概览

简要总结

Changes in voice performance in the postoperative period due to trauma suffered during endotracheal intubation or edema occurring in the postoperative period are often observed. The present study aimed to evaluate the effect of different types of intubation tube applications on voice performance in the early postoperative period using objective and subjective voice analysis methods.

详细描述

A total of 88 patients who underwent endotracheal intubation either using a cuffed endotracheal (n = 44) or spiral-embedded cuffed endotracheal (n = 44) tube were included in this study. An endotracheal tube of 7.5 mm was used for female patients and that of 8 mm was used for male patients. A preoperative acoustic voice analysis was performed, and fundamental frequency (F0), jitter%, and shimmer% values were recorded. In addition, voice handicap index-30 (VHI-30) questionnaire was completed by the patients for subjective evaluation. The same procedure was repeated in the first 48 hours postoperatively. The preoperative and postoperative data were statistically compared. In addition, the effect of the type of endotracheal intubation tube on acoustic voice analysis parameters and VHI-30 scores was statistically evaluated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-80 years
  • Conforming to the ASA I-II class according to the classification of the American Society of -Anesthesiologists (ASA)
  • who were scheduled to undergo surgery that will not last more than 120 minutes

排除标准

  • Patients with a lung disease
  • Having obesity (BMI >35 kg.m-2)
  • Pregnant patients
  • Gastroesophageal reflux
  • Suspected of having difficult airway (mouth opening <2.5 cm, Mallampati score >2, sternomental distance <12.5 cm, thyromental distance <6 cm, neck circumference >40 cm)
  • A high risk of aspiration pneumonia
  • Using inhaled steroids

结局指标

主要结局

F0 (Fundemental frequency)

时间窗: Preoperative period

Acustic voice analysis parameter

Jitter%

时间窗: Preoperative period

Acustic voice analysis parameter

Shimmer%

时间窗: Preoperative period

Acustic voice analysis parameter

Voice Handicap Index-30

时间窗: Preoperative period

Subjective voice analysis parameter

次要结局

  • F0 (Fundemental frequency)(Postoperative first 48 hours period)
  • Jitter%(Postoperative first 48 hours period)
  • Shimmer%(Postoperative first 48 hours period)
  • Voice Handicap Index-30(Postoperative first 48 hours period)

研究者

发起方
Hitit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Doğan Atan

Assoc. Prof.

Hitit University

研究点 (1)

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