Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intubation Tube Applications on Voice Performance in Early Postoperative Period

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011111
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Doğan Atan, Hitit University

Brief Summary:
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.

Condition or disease Intervention/treatment
Voice Alteration Intubation Complication Procedure: Intubation tube and voice analysis

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Objective and Subjective Evaluations of the Effect of Different Types of Intubation Tube Applications on Voice Performance in Early Postoperative Period
Actual Study Start Date : January 20, 2019
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : March 31, 2019

Intervention Details:
  • Procedure: Intubation tube and voice analysis
    After the ıntubation tube application, done voice analysis early postoperative period


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Male and female adults
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011111


Locations
Layout table for location information
Turkey
Hitit University Faculty of Medicine
Çorum, Turkey, 19100
Sponsors and Collaborators
Hitit University
Layout table for additonal information
Responsible Party: Doğan Atan, Assoc. Prof., Hitit University
ClinicalTrials.gov Identifier: NCT04011111    
Other Study ID Numbers: 2019/109
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Doğan Atan, Hitit University:
voice
intubation
subjective
objective