Voice Disorder Due to Iatrogenic FactorVOICENCT07131800
Objective and Perceptual Characteristics of the Voice After Endotracheal Intubation in Head and Neck Surgery
An observational study of Voice Disorder Due to Iatrogenic Factor and Endotracheal Intubation During Surgery, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial summary
Introduction: Possible consequences of endotracheal intubation are post-intubation voice changes. Hypothesis: Endotracheal intubation during head and neck surgery is associated with objective and perceptual voice disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Disorder Due to Iatrogenic Factor, Endotracheal Intubation During Surgery, Thyroid Surgery
- How many people
- 180 participants
- Where
- 1 siteCroatia
- Study dates
- 25 Sep 2024to 30 Mar 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- patients scheduled for elective thyroid, head and neck surgery or abdominal surgery
- 18 and 70 years,
- normal preoperative voice status, and
- normal laryngeal status.
Who cannot join
- <18 years in the time of surgery
- history of previous head and neck operation or radiotherapy
- patients scheduled for head and neck operation that can alter acoustic characteristics of the voice (surgery of the nasal cavity, ear surgery, laryngeal surgery, jaw surgery).
- Patients with preoperatively diagnosed pathologic vocal cord findings (nodules, polyps, vocal cord paralysis),
- patients with postoperative injuries of the vocal cords, recurrent and superior laryngeal nerve,
- patients with laryngopharyngeal reflux,
- patients in whom postoperative evaluation of the voice cannot be performed due to uncooperativeness will also be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Introduction: Possible consequences of endotracheal intubation are post-intubation voice changes.
Hypothesis: Endotracheal intubation during head and neck surgery is associated with objective and perceptual voice disorders.
Read more
Research objective: To investigate the short-term and long-term effects of endotracheal intubation on voice quality during head and neck surgery.
Material, subjects, methodology and research design: A prospective observational cohort study that will include patients undergoing surgery and endotracheal intubation lasting up to 3 hours. Adult patients divided into three groups will be included in the research: thyroid surgery, parotid gland surgery and abdominal surgery. Videostroboscopy, perceptual and objective acoustic voice analysis will be recorded before surgery, on the second postoperative day, two weeks and 1 month after surgery.
Expected scientific contribution of the proposed research: The scientific contribution would be an understanding of the risk factors and the connection of voice disorders after endotracheal intubation, as well as the ability to determine differences in this risk in patients undergoing different operations.
Read the detailed description
study protocol has been published and is attached below
- 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
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing thyroid surgery | Patients undergoing scheduled thyroid surgery at the University Hospital Centre Zagreb under general endotracheal anesthesia without preoperative voice disorder regardless of the cause (previous operations or irradiation on the neck, and damage to the recurrent laryngeal nerve (RLN) during thyroidectomy). | |
| Patients undergoing abdominal surgery | Patients undergoing scheduled abdominal surgery at Day surgery of University Hospital Centre Zagreb under general anesthesia without preoperative voice disorder regardless of the cause (previous operations or irradiation on the neck, and damage to the recurrent laryngeal nerve (RLN) during thyroidectomy). This will include laparoscopic abdominal procedures and other minor abdominal procedures done in Day surgery, and will be control group for head and neck surgical procedures. | |
| Patients undergoing other head and neck surgery besides thyroid | Patients undergoing scheduled head and neck surgeries beside thyroid surgery at the University Hospital Centre Zagreb under general endotracheal anesthesia without preoperative voice disorder regardless of the cause (previous operations or irradiation on the neck, and damage to the recurrent laryngeal nerve (RLN) during thyroidectomy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Measured: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
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)
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
Measured: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
Videostroboscopy Evaluation before and after surgery
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.
Measured: Preoperative (within 7 days before surgery) and Postoperative day 1
Objective Acoustic and Aerodynamic Voice Analysis - changes in fundamental frequency before and after surgery
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,
Measured: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
Secondary outcomes (4)
Objective Acoustic and Aerodynamic Voice Analysis - changes in Intensity before and after surgery
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:
- Intensity (in dB)
Physiological reference values:
- Intensity: Female: 68-74 dB, Male: 68-76 dB
Measured: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
Objective Acoustic and Aerodynamic Voice Analysis- changes in Jitter before and after surgery
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:
- Jitter (%)
Physiological reference values:
- Jitter: 0-0.5%
Measured: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
Objective Acoustic and Aerodynamic Voice Analysis- changes in shimmer before and after surgery
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:
- Shimmer (%)
Physiological reference values:
- Shimmer: 0-5%
Measured: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
Objective Acoustic and Aerodynamic Voice Analysis- changes in Maximum phonation time before and after surgery
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:
- Maximum phonation time (MPT, in seconds)
Physiological reference values:
- Maximum phonation time: Female: 15-25 sec, Male: 25-35 sec
Measured: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start25 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Voice Disorder Due to Iatrogenic FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Curić Radivojević, Clinical Hospital Centre Zagreb
- Investigators
- Ivana Šimić Prgomet, PhD, mag.logoped, Professor log., Principal investigator, Clinical Hospital Centre ZagrebDrago Prgomet, MD; PhD, Professor, Study director, Clinical Hospital Centre ZagrebRenata Curić Radiovjević, Primarius, Study chair, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131800
- Sponsor's protocol ID
- Klasa8.1-23/209-3;Broj02/013AG
- Acronym
- VOICE
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the moment, we do not know other logopedic laboratory being able to perform the same audiometric evaluation.
Publications
Simic 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.
PubMed 38746618
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.
Introduction: Possible consequences of endotracheal intubation are post-intubation voice changes.
Hypothesis: Endotracheal intubation during head and neck surgery is associated with objective and perceptual voice disorders.
Research objective: To investigate the short-term and long-term effects of endotracheal intubation on voice quality during head and neck surgery.
Material, subjects, methodology and research design: A prospective observational cohort study that will include patients undergoing surgery and endotracheal intubation lasting up to 3 hours. Adult patients divided into three groups will be included in the research: thyroid surgery, parotid gland surgery and abdominal surgery. Videostroboscopy, perceptual and objective acoustic voice analysis will be recorded before surgery, on the second postoperative day, two weeks and 1 month after surgery.
Expected scientific contribution of the proposed research: The scientific contribution would be an understanding of the risk factors and the connection of voice disorders after endotracheal intubation, as well as the ability to determine differences in this risk in patients undergoing different operations.
Detailed description
study protocol has been published and is attached below
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing thyroid surgery | – | –Patients undergoing scheduled thyroid surgery at the University Hospital Centre Zagreb under general endotracheal anesthesia without preoperative voice disorder regardless of the cause (previous operations or irradiation on the neck, and damage to the recurrent laryngeal nerve (RLN) during thyroidectomy). |
| Patients undergoing abdominal surgery | – | –Patients undergoing scheduled abdominal surgery at Day surgery of University Hospital Centre Zagreb under general anesthesia without preoperative voice disorder regardless of the cause (previous operations or irradiation on the neck, and damage to the recurrent laryngeal nerve (RLN) during thyroidectomy). This will include laparoscopic abdominal procedures and other minor abdominal procedures done in Day surgery, and will be control group for head and neck surgical procedures. |
| Patients undergoing other head and neck surgery besides thyroid | – | –Patients undergoing scheduled head and neck surgeries beside thyroid surgery at the University Hospital Centre Zagreb under general endotracheal anesthesia without preoperative voice disorder regardless of the cause (previous operations or irradiation on the neck, and damage to the recurrent laryngeal nerve (RLN) during thyroidectomy). |
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.
Key inclusion criteria (4 listed)
- patients scheduled for elective thyroid, head and neck surgery or abdominal surgery
- 18 and 70 years,
- normal preoperative voice status, and
- normal laryngeal status.
Key exclusion criteria (7 listed)
- <18 years in the time of surgery
- history of previous head and neck operation or radiotherapy
- patients scheduled for head and neck operation that can alter acoustic characteristics of the voice (surgery of the nasal cavity, ear surgery, laryngeal surgery, jaw surgery).
- Patients with preoperatively diagnosed pathologic vocal cord findings (nodules, polyps, vocal cord paralysis),
- patients with postoperative injuries of the vocal cords, recurrent and superior laryngeal nerve,
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
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
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
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.
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,
4 secondary outcomes
Objective Acoustic and Aerodynamic Voice Analysis - changes in Intensity before and after surgery
Time frame: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
Objective Acoustic and Aerodynamic Voice Analysis- changes in Jitter before and after surgery
Time frame: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
Objective Acoustic and Aerodynamic Voice Analysis- changes in shimmer before and after surgery
Time frame: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
Objective Acoustic and Aerodynamic Voice Analysis- changes in Maximum phonation time before and after surgery
Time frame: Time Points: Preoperative (within 7 days before surgery), Postoperative Day 1, Week 2, and Week 4
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.
Ivana Šimić Prgomet, PhD, mag.logoped, Professor log. principal investigator
Clinical Hospital Centre Zagreb
Drago Prgomet, MD; PhD, Professor study director
Clinical Hospital Centre Zagreb
Renata Curić Radiovjević, Primarius study chair
Clinical Hospital Centre Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Disorder Due to Iatrogenic Factor and Endotracheal Intubation During Surgery, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07131800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.