Intubation Tube Applications on Voice Performance in Early Postoperative Period

July 3, 2019 updated by: Doğan Atan, Hitit University

Objective and Subjective Evaluations of the Effect of Different Types of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Çorum, Turkey, 19100
        • Hitit University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female adults

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
F0 (Fundemental frequency)
Time Frame: Preoperative period
Acustic voice analysis parameter
Preoperative period
Jitter%
Time Frame: Preoperative period
Acustic voice analysis parameter
Preoperative period
Shimmer%
Time Frame: Preoperative period
Acustic voice analysis parameter
Preoperative period
Voice Handicap Index-30
Time Frame: Preoperative period
Subjective voice analysis parameter
Preoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
F0 (Fundemental frequency)
Time Frame: Postoperative first 48 hours period
Acustic voice analysis parameter
Postoperative first 48 hours period
Jitter%
Time Frame: Postoperative first 48 hours period
Acustic voice analysis parameter
Postoperative first 48 hours period
Shimmer%
Time Frame: Postoperative first 48 hours period
Acustic voice analysis parameter
Postoperative first 48 hours period
Voice Handicap Index-30
Time Frame: Postoperative first 48 hours period
Subjective voice analysis parameter
Postoperative first 48 hours period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hitit University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2019

Primary Completion (Actual)

February 22, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 8, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019/109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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