Intubation Tube Applications on Voice Performance in Early Postoperative Period

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011111
• Other study ID #: 2019/109
• Status: Completed
• Start date: January 20, 2019
• Est. completion date: March 31, 2019

Study information

• Verified date: July 2019
• Source: Hitit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 31, 2019
• Est. primary completion date: February 22, 2019
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication
• Voice Alteration

Intervention

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

Locations

Country	Name	City	State
Turkey	Hitit University Faculty of Medicine	Çorum

Sponsors (1)

Lead Sponsor	Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	F0 (Fundemental frequency)	Acustic voice analysis parameter	Preoperative period
Primary	Jitter%	Acustic voice analysis parameter	Preoperative period
Primary	Shimmer%	Acustic voice analysis parameter	Preoperative period
Primary	Voice Handicap Index-30	Subjective voice analysis parameter	Preoperative period
Secondary	F0 (Fundemental frequency)	Acustic voice analysis parameter	Postoperative first 48 hours period
Secondary	Jitter%	Acustic voice analysis parameter	Postoperative first 48 hours period
Secondary	Shimmer%	Acustic voice analysis parameter	Postoperative first 48 hours period
Secondary	Voice Handicap Index-30	Subjective voice analysis parameter	Postoperative first 48 hours period