Airway Obstruction, Vocal Cord Paralysis
Conditions
Keywords
Vocal cords, Vocal cord paralysis, Arytenoid cartilage
Brief summary
Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss than other operations performed for bilateral vocal fold paralysis (BVFP). However, objective evidence for such conclusion is lacking. There is no study comparing swallowing and voice after total and partial arytenoidectomy.
Detailed description
Design: Prospective, randomized, double-blind, case-control Setting: Tertiary, referral, university Patients: Twenty patients with BVFP Intervention: Endoscopic total and partial arytenoidectomy
Interventions
PROCEDURETotal arytenoidectomy
Endoscopic total arytenoidectomy was performed on patients with bilateral vocal fold paralysis
PROCEDUREPartial arytenoidectomy
Endoscopic partial arytenoidectomy was performed on patients with bilateral vocal fold paralysis
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Bilateral vocal fold paralysis
Exclusion criteria
* Previously operated patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decannulation | From the day of operation until 52 weeks after arytenoidectomy | Preoperative examinations were repeated 1 year after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of operation | At the day of operation | The duration of operation was measured in minutes at the day of operation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Aerodynamic analysis | From the day of operation until 52 weeks after arytenoidectomy | Maximum phonation time (seconds), mean flow rate (liters/second), mean resistance (cmH20/liter/second), mean power (Watt), mean efficiency (ppm) and mean pressure (cmH2O)are obtained as physical measures of aerodynamic analysis. |
| Postoperative breathing ability | 52 weeks after arytenoidectomy | Breathing ability was evaluated on a scale of -2 to +2 (-2: significantly worse; -1: somewhat worse; 0: no change; +1: somewhat better; +2: significantly better). |
| Voice Handicap Index | From the day of operation until 52 weeks after arytenoidectomy | Voice Handicap Index is a 30-item questionnaire. Possible points change between 0 to 120. Zero means normal voice, 120 means the worst voice. Preoperative examinations were repeated 1 year after surgery. |
| Speech intensity | 52 weeks after arytenoidectomy | Speech intensity is measured in decibels. |
| Functional outcome swallowing scale | 52 weeks after arytenoidectomy | Functional Outcome Swallowing Scale: 0-5 (0: Normal function and asymptomatic; 1: Normal function with episodic or daily symptoms of dysphagia; 2: Compensated abnormal function manifested by significant dietary modifications or prolonged mealtime (without weight loss or aspiration); 3: Decompensated abnormal function with weight loss of \<10% of body weight over 6 months due to dysphagia; or daily cough, gagging or aspiration during meals; 4: Severely decompensated abnormal function with weight loss of \>10% of body weight over 6 months due to dysphagia; or severe aspiration with bronchopulmonary complications. Non oral feeding for most nutrition; 5: Non oral feeding for all nutrition). |
| Subjective comparison of pre- and postoperative voice by a phoniatrician | From the day of operation until 52 weeks after arytenoidectomy | Subjective comparison of pre- and postoperative voice on a scale of -2 to +2 (-2: significantly worse; -1: somewhat worse; 0: no change; +1: somewhat better; +2: significantly better). |
| Acoustic analysis | From the day operation until 52 weeks after arytenoidectomy | Fundamental frequency (Hertz), absolute jitter (microseconds), shimmer percent (%), noise to harmonic ratio will be measured as physical measures of voice. |
Countries
Turkey (Türkiye)
Outcome results
None listed