Trial Outcomes & Findings for Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients (NCT NCT05561920)

Phonatory Movement of the Pharyngoesophageal Mucosa in Laryngectomy Patients

Visual recording of the mucosa of the pharyngoesophageal segment (PES) performed with High speed video endoscopy (HSV) during the phonation of the vowel "a".The video recordings of the PES were made with a 90° rigid HSV system Wolf 5562 Hres ENDOCAM (frame rate: 4000 fps, resolution: 256×256 pixels). All subjects phonated the vowel "a" at a comfortable pitch and volume. Visual assessment of the HSV recordings was performed using the protocol including the assessments of the overall quality of the recordings (assessability, brightness and focus) and the assessments of anatomical and morphological features of the PES: amount of saliva, visibility and shape of the PES, location of visible vibration, presence of a mucosal wave and regularity of the vibration.

The acoustic analysis of the tracheoesophageal (TE) voice with a voice prosthesis was performed in a quiet room (ambient noise \< 50 dB) with a microphone placed 30 cm from the mouth to create optimal conditions for recording and analysis. Three consecutive measurements were taken. The voice recordings were analysed using the acoustic programme lingWAVES (Voice and speech analyser version 2.x software). The fundamental frequency (Hz) parameter was recorded from the central part of the best recording

The acoustic analysis of the tracheoesophageal (TE) voice with a voice prosthesis was performed in a quiet room (ambient noise \< 50 dB) with a microphone placed 30 cm from the mouth to create optimal conditions for recording and analysis. Three consecutive measurements were taken. The voice recordings were analysed using the acoustic programme lingWAVES (Voice and speech analyser version 2.x software). Intensity of substitute voice was recorded from the central part of the best recording

The acoustic analysis of the tracheoesophageal (TE) voice with a voice prosthesis was performed in a quiet room (ambient noise \< 50 dB) with a microphone placed 30 cm from the mouth to create optimal conditions for recording and analysis. Three consecutive measurements were taken. The voice recordings were analysed using the acoustic programme lingWAVES (Voice and speech analyser version 2.x software). The following parameters were recorded from the central part of the best recording: jitter (%), shimmer (%)

Measurement of the longest possible relaxed phonation of the voice "a" by a speech therapist The maximum phonation time (measured in seconds) for which a person can sustain a vowel sound when produced on 1 deep breath at a comfortable pitch and loudness and is a common clinical measure of glottal efficiency.

Completing the Croatian version of the Self-Evaluation of Communication Experiences after Laryngectomy (SECEL) questionnaire. Questionnaire consists of two parts. The first part examines the relevant general data on the person filling out the questionnaire, while the second part consists of 35 items questionably or statement-designed to examine communication experiences. Patients estimates the incidence of these communication difficulties on the Likert scale (0-never, 1-sometimes, 2-often, 3-always). The 35 items are divided into 3 subscales: General (0-15 points), Environment (0-42 points) and Attitude (0-45 points). Item number 35 is a separate question: "Do you talk the same amount now as you did before your laryngectomy?" and is scored with the rating categories "yes"," "more" and "less". The total numerical score ranges from 0 to 102, with a higher score indicating greater difficulty and poorer postoperative adaptation of speech communication.

The development of the biomechanical model of the PES aims to quantify non-stationary pharyngoesophageal vibrations and draw conclusions about the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PES. The biomechanical model identifies mathematical dependencies and analyses extracted time signals of the PES opening and contours (i.e. the opening and closing of the vibrating mucosa of the PES). The PES waveform allows calculation of relative shimmer (%), relative jitter (%), and the duration of the open and closed phases (%), or the percentage of open or closed time of the PES, which is calculated from the PES waveform using the formulas listed in reference 5.

The development of the biomechanical model of the PES in order to quantify non-stationary pharyngoesophageal vibrations and drawing conclusions on the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PES. The biomechanical model identify mathematical dependencies and analyse extracted time signals of the PES opening and contours (i.e. the opening and closing of the vibrating mucosa of the PES). The PES waveform allowed us to calculate mean shimmer (dB).

The development of the biomechanical model of the PES in order to quantify non-stationary pharyngoesophageal vibrations and drawing conclusions on the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PES. The biomechanical model identify mathematical dependencies and analyse extracted time signals of the PES opening and contours (i.e. the opening and closing of the vibrating mucosa of the PES). The PES waveform allowed us to calculate mean jitter (s).

The development of the biomechanical model of the PES in order to quantify non-stationary pharyngoesophageal vibrations and drawing conclusions on the temporal characteristics of tissue stiffness, oscillating mass, pressure, and geometric distributions within the PES. The biomechanical model identify mathematical dependencies and analyse extracted time signals of the PES opening and contours (i.e. the opening and closing of the vibrating mucosa of the PES). The PES waveform allowed us to calculate the fundamental frequency (Hz).