Objective and Perceptual Characteristics of the Voice After Endotracheal Intubation in Head and Neck Surgery

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Objective and Perceptual Characteristics of the Voice After Endotracheal Intubation in Head and Neck Surgery

ClinicalTrials.gov ID

NCT07131800

Acronym / sponsor ID

VOICE / Klasa8.1-23/209-3;Broj02/013AG

Conditions

Voice Disorder Due to Iatrogenic Factor, Endotracheal Intubation During Surgery, Thyroid Surgery, Head and Neck Surgery

Keywords

endotracheal intubation, surgery, head and neck, voice disorder, VHI

Study type

Observational

Recruitment status

Enrolling by invitation

Enrolment

180 participants (estimated)

Lead sponsor

Clinical Hospital Centre ZagrebUniversity, hospital or other

Study start

25 Sep 2024 (actual)

Primary completion

31 Dec 2025 (estimated)

Study completion

30 Mar 2026 (estimated)

First posted

20 Aug 2025 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

3 Months

Number of arms

3

Who may qualify

Ages

18 to 70 years

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Study population

Patients scheduled for elective thyroid, head and neck surgery or abdominal surgery at the University Hospital Centre Zagreb. All eligible patients will be divided into three groups, as follows: patients scheduled for thyroid gland surgery; patients scheduled for some other type of head and neck operation that does not fall to exclusion criteria (parotidectomy, extirpation of congenital neck cyst, etc.); and control group including patients scheduled for operation other than the head and neck region. All operations will be performed by experienced operators with more than 100 annual procedures.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Subjective analysis of voice changes before and after endotracheal intubation for thyroid surgery, other head and neck surgery and abdominal surgery using Voice Handicap Index (VHI)

   Time frame: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4

   The Voice Handicap Index (VHI) is one of the most frequently used self-assessment scales for voice disorders. The Croatian version was adapted and validated by Bonetti and Bonetti (2013), while Benšić et al. (2024) confirmed normative values for the Croatian language. The scale consists of 30 items divided into three subscales: - Functional, emotional and physical component. Each item is rated on a 5-point Likert scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Almost Always, 4 = Always), giving a total score from 0 to 120, with higher scores indicating greater perceived voice handicap. Participants will complete the VHI questionnaire at Baseline (within 7 days before surgery with endotracheal intubation) and at postoperative follow-up time points (Day 1, Week 2, and Week 4). The primary VHI outcome is the change in total score before and after surgery. Units of Measure: • Total score range: 0-120 Method of Administration: • Self-administered paper

2. Subjective analysis of voice changes before and after endotracheal intubation for thyroid surgery, other head and neck surgery and abdominal surgery using GRBAS Scale (Perceptual Voice Evaluation)

   Time frame: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4

   The perceptual voice assessment (GRBAS) will be conducted by two speech-language pathologists with several years of clinical experience. Each parameter-Grade, Roughness, Breathiness, Asthenia, and Strain-will be scored on a 4-point scale (0 = Normal, 1 = Slight, 2 = Moderate, 3 = Severe). The average of the two evaluators' scores will be taken, and in the case of significant discrepancies, a third evaluator will be consulted to reach consensus. Voice samples will be recorded at baseline and post-intervention at 4 time points total. The primary GRBAS outcome will be the change in the 'Grade' score; secondary analyses will include changes in R, B, A, and S. Units of Measure: • Ordinal scores (0-3) for each parameter

3. Videostroboscopy Evaluation before and after surgery

   Time frame: Preoperative (within 7 days before surgery) and Postoperative day 1

   Videostroboscopy uses an endoscope containing a built-in video camera and a stroboscope, which records phonation while the vocal cords are being filmed. The recording captures the frequency of vocal cord vibrations during voice production and provides an apparently slow-motion view of these vibrations. In the stroboscopic video, the movements of the vocal cords are slowed down enough to precisely follow their motion. This technique allows detailed observation of the amplitude and symmetry of vibrations, as well as the phase of vocal cord closure during voice production. It facilitates diagnosis of numerous physical problems with the vocal cords, including paresis resulting from injury to the recurrent laryngeal nerve. Evaluations will be performed pre- and post-intervention using a standardized protocol. 2 experienced phoniatrists will independently review the recordings to identify possible pathology in vocal fold motion or structural damage. No formal scoring system will be applied.

4. Objective Acoustic and Aerodynamic Voice Analysis - changes in fundamental frequency before and after surgery

   Time frame: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4

   Objective voice evaluation will be performed using selected acoustic and aerodynamic measures. Voice assessment involves recording sustained phonation of the vowel /a/ in a sound-treated room using a calibrated digital recording system. The recordings will be acquired with a high-quality microphone positioned at a fixed distance of 30 cm from the participant's mouth, placed at a 45° angle. The sound signal will be analyzed using the LingWAVES SLP Suite Pro VPR software (WEVOSYS medical technology GmbH, Germany). This software converts the analog voice signal to digital form and processes it to extract relevant voice parameters. Parameters to be evaluated: • Fundamental frequency (F0) in Hz. Physiological reference values: • Fundamental frequency: Female: ~206 Hz, Male: ~120 Hz,

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
• Background: PubMed 38746618Simic I, Curic Radivojevic R, Slipac J, Prgomet D. VOICE CONDITION FOLLOWING SHORT-TERM ENDOTRACHEAL INTUBATION IN HEAD AND NECK SURGERY: STUDY PROTOCOL FOR CLINICAL TRIAL. Acta Clin Croat. 2023 Apr;62(Suppl1):49-54. doi: 10.20471/acc.2023.62.s1.06.
• Individual participant dataSharing planned: No. At the moment, we do not know other logopedic laboratory being able to perform the same audiometric evaluation.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

1 site in 1 country: see every site and its status.