Intubation Tube Applications on Voice Performance in Early Postoperative Period

Completed

• Conditions: Voice Alteration; Intubation Complication

• Registration Number: NCT04011111
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-01-20
• Primary Completion: 2019-02-22
• Study Completion: 2019-03-31
• Status Verified: 2019-07
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-03
• Last Update Submitted: 2019-07-03
• Study First Posted: 2019-07-08
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
F0 (Fundemental frequency)	Preoperative period	Acustic voice analysis parameter
Jitter%	Preoperative period	Acustic voice analysis parameter
Shimmer%	Preoperative period	Acustic voice analysis parameter
Voice Handicap Index-30	Preoperative period	Subjective voice analysis parameter

Secondary Outcome Measures

Name	Time	Method
F0 (Fundemental frequency)	Postoperative first 48 hours period	Acustic voice analysis parameter
Jitter%	Postoperative first 48 hours period	Acustic voice analysis parameter
Shimmer%	Postoperative first 48 hours period	Acustic voice analysis parameter
Voice Handicap Index-30	Postoperative first 48 hours period	Subjective voice analysis parameter

Trial Locations

Locations (1)

Hitit University Faculty of Medicine; 🇹🇷 Çorum, Turkey