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Completed

NCT Number: NCT04011111

Intubation Tube Applications on Voice Performance in Early Postoperative Period

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hitit University Faculty of Medicine

Çorum, 19100, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Intubation tube and voice analysis

Procedure

After the ıntubation tube application, done voice analysis early postoperative period

Primary outcomes

  1. F0 (Fundemental frequency)

    Time frame: Preoperative period

    Acustic voice analysis parameter

  2. Jitter%

    Time frame: Preoperative period

    Acustic voice analysis parameter

  3. Shimmer%

    Time frame: Preoperative period

    Acustic voice analysis parameter

  4. Voice Handicap Index-30

    Time frame: Preoperative period

    Subjective voice analysis parameter

Secondary outcomes

  1. F0 (Fundemental frequency)

    Time frame: Postoperative first 48 hours period

    Acustic voice analysis parameter

  2. Jitter%

    Time frame: Postoperative first 48 hours period

    Acustic voice analysis parameter

  3. Shimmer%

    Time frame: Postoperative first 48 hours period

    Acustic voice analysis parameter

  4. Voice Handicap Index-30

    Time frame: Postoperative first 48 hours period

    Subjective voice analysis parameter

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2019
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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