Clinical trial NCT04011111: Intubation Tube Applications on Voice Performance in Early Postoperative Period
Official title: Objective and Subjective Evaluations of the Effect of Different Types of Intubation Tube Applications on Voice Performance in Early Postoperative Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voice Alteration
Intubation Complication
Keywords: voice
intubation
subjective
objective
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female adults

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.

Eligibility 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

Primary outcomes:
measure: F0 (Fundemental frequency)
timeFrame: Preoperative period
measure: Jitter%
timeFrame: Preoperative period
measure: Shimmer%
timeFrame: Preoperative period
measure: Voice Handicap Index-30
timeFrame: Preoperative period
Secondary outcomes:
measure: F0 (Fundemental frequency)
timeFrame: Postoperative first 48 hours period
measure: Jitter%
timeFrame: Postoperative first 48 hours period
measure: Shimmer%
timeFrame: Postoperative first 48 hours period
measure: Voice Handicap Index-30
timeFrame: Postoperative first 48 hours period
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hitit University Faculty of Medicine
Study officials:
References: