University Hospital Centre Zagreb
Zagreb, 10000, Croatia
NCT Number: NCT07131800
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Observational
Zagreb, 10000, Croatia
study protocol has been published and is attached below
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
The primary VHI outcome is the change in total score before and after surgery.
Units of Measure:
Method of Administration:
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:
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.
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:
Physiological reference values:
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:
Physiological reference values:
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:
Physiological reference values:
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:
Physiological reference values:
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:
Physiological reference values:
Clinical Hospital Centre Zagreb
Other
Acronym: VOICE
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