Intubation Tube Applications on Voice Performance in Early Postoperative Period

NCT ID: NCT04011111

Last Updated: 2019-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-20

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Voice Alteration Intubation Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Intubation tube and voice analysis

After the ıntubation tube application, done voice analysis early postoperative period

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hitit University

OTHER

Sponsor Role lead

Responsible Party

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Doğan Atan

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hitit University Faculty of Medicine

Çorum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019/109

Identifier Type: -

Identifier Source: org_study_id

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