Pulmonary Function, Voice and Swallowing Symptoms After Parathyroidectomy

NCT04267965 | Completed

• 1 other identifier: 201601901B0
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, investigators measure patient's voice frequency, swallowing function, and O2 desaturation of the 6 mins walking test before surgery and 4 months after surgery, to find the increase of voice frequency, and swallowing function and the decrease of O2 desaturation.

Conditions

Secondary Hyperparathyroidism Due to Renal Causes

Keywords

Voice impairment; airway invasion; respiratory function

Outcome Measures

Primary Outcomes (9)

• Successful surgery is defined as iPTH levels less than 72 pg/dL within one week after surgery

  After successful surgery, patients were recruited in the study, and we excluded patients with a surgical failure.

  one week after surgery

• Voice impairment(GRBAS)

  speech impairment and speech quality were evaluated with GRBAS on a scale (0-3), VHI-10 (\>11, abnormal) and (EAT-10) (≥ 3, abnormal) . \*GRBAS (grade, roughness, breathiness, asthenia, strain) scale grades hoarseness, roughness, breathiness, aesthenia (weakness), and strain on a scale of 0-3 0 = normal, 1 = mild degree, 2 = moderate degree, and 3 = high degree

  4 months after surgery

• Voice impairment(VH1-10)

  speech impairment and speech quality were evaluated with voice handicap index (VHI-10) (\>11, abnormal) 0-4 Rating Scale 0 = Normal 1. = Almost Normal 2. = Sometimes 3. = Abnormal 4. = Always

  4 months after surgery

• Voice impairment(EAT-10)

  speech impairment and speech quality were evaluated with EAT-10 (≥ 3, abnormal) . \*eating assessment tool (EAT-10) 0 - 4 Rating Scale 0 = No problem 1. = Mild Problem 2. = Mild to moderate 3. = Moderate problem 4. = Severe problem

  4 months after surgery

• Acoustic voice analysis

  mean frequency (F0, Hz); Noise-to-Harmonic Ratio (NHR), jitter(%), and shimmer (%)

  4 months after surgery

• Vocal cord examination

  The maximal phonation time (sec) and s/z ratio were measured with circumferentially vented pneumotachography mask and differential transducers of the Aerophone system .

  4 months later

• Fiber optic endoscopic evaluation of swallowing (FEES)

  Vocal cord mobility, vocal cord closure (complete or incomplete), airway invasion during swallowing were inspected with fiber-optic endoscopy to show premature spillage, penetration-aspiration scale levels . The Yale pharyngeal residue severity rating scale for vallecula and pyriform sinus (0-4) (non-trace-mild-moderate-severe) and pyriform sinus (0-4) were also performed.

  4 months later.

• Pulmonary function test

  Forced vital capacity (FVC) (L), forced expiratory volume in 1 second (FEV1), bronchodilator test (BDT) (a positive response to BDT defined by the American Thoracic Society as an increase in FEV1 or FVC ≥ 12% and 200 ml), total lung capacity (TLC) (L), and alveolar volume (VA) using MasterScope (Jaeger, VIASYS healthcare GmbH, Höchberg, Germany), and diffusion capacity of the lung for carbon monoxide (DLCO) (%) using Vmax Autobox (SensorMedics, a subsidiary of VIASYS healthcare, California, USA).

  4 months later

• 6MWT were performed.

  The 6 minutes walking test (6MWT) was also performed to evaluate distance (meter) and O2 desaturation (differences of O2 saturation between pre- and post-tests) (defined as positive if O2 desaturation ≧ 4%).

  4 months later

Study Arms (2)

Group A

Patients who have been successfully operated on with total parathyroidectomy for symptomatic secondary hyperparathyroidism and their PTH levels are below 72 pg/dL within one week after surgery.

Procedure: parathyroidectomy plus bilateral thymectomy and autotransplantation

Group B

Patients who have had regular dialysis and their iPTH levels are around 500 pg/dL

Interventions

parathyroidectomy plus bilateral thymectomy and autotransplantation PROCEDURE

Patients should receive total parathyroidectomy plus bilateral thymectomy and autotransplantation

Group A

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We included patients who had symptomatic secondary hyperparathyroidism and were successfully operated during the two years period (Aug 1 2017 - July 31 2019).

You may qualify if:

• age over 20 years
• chronic renal failure with regular dialysis
• iPTH\> 800pg/mL, Ca \> 10.1 mg/dL, and P \> 5.5 mg/dL
• symptoms of bone pain, skin itching, general weakness, insomnia and osteoporosis (T score\< -2.5)

You may not qualify if:

• pregnancy women
• patients after kidney transplantation
• a failure in surgery

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Fong-Fu Chou

Kaohsiung City, 833, Taiwan

Location

Related Publications (10)

• Okada M, Tominaga Y, Yamamoto T, Hiramitsu T, Narumi S, Watarai Y. Location Frequency of Missed Parathyroid Glands After Parathyroidectomy in Patients with Persistent or Recurrent Secondary Hyperparathyroidism. World J Surg. 2016 Mar;40(3):595-9. doi: 10.1007/s00268-015-3312-1.

  PMID: 26563219 RESULT

• Wood JM, Athanasiadis T, Allen J. Laryngitis. BMJ. 2014 Oct 9;349:g5827. doi: 10.1136/bmj.g5827. No abstract available.

  PMID: 25300640 RESULT

• Arffa RE, Krishna P, Gartner-Schmidt J, Rosen CA. Normative values for the Voice Handicap Index-10. J Voice. 2012 Jul;26(4):462-5. doi: 10.1016/j.jvoice.2011.04.006. Epub 2011 Aug 4.

  PMID: 21816570 RESULT

• Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.

  PMID: 19140539 RESULT

• Eckel FC, Boone DR. The S/Z ratio as an indicator of laryngeal pathology. J Speech Hear Disord. 1981 May;46(2):147-9. doi: 10.1044/jshd.4602.147.

  PMID: 7253591 RESULT

• Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.

  PMID: 8721066 RESULT

• Neubauer PD, Rademaker AW, Leder SB. The Yale Pharyngeal Residue Severity Rating Scale: An Anatomically Defined and Image-Based Tool. Dysphagia. 2015 Oct;30(5):521-8. doi: 10.1007/s00455-015-9631-4. Epub 2015 Jun 7.

  PMID: 26050238 RESULT

• Richter DC, Joubert JR, Nell H, Schuurmans MM, Irusen EM. Diagnostic value of post-bronchodilator pulmonary function testing to distinguish between stable, moderate to severe COPD and asthma. Int J Chron Obstruct Pulmon Dis. 2008;3(4):693-9. doi: 10.2147/copd.s948.

  PMID: 19281083 RESULT

• Single breath carbon monoxide diffusing capacity (transfer factor). Recommendations for a standard technique. Statement of the American Thoracic Society. Am Rev Respir Dis. 1987 Nov;136(5):1299-307. doi: 10.1164/ajrccm/136.5.1299. No abstract available.

  PMID: 3674590 RESULT

• Waatevik M, Johannessen A, Gomez Real F, Aanerud M, Hardie JA, Bakke PS, Lind Eagan TM. Oxygen desaturation in 6-min walk test is a risk factor for adverse outcomes in COPD. Eur Respir J. 2016 Jul;48(1):82-91. doi: 10.1183/13993003.00975-2015. Epub 2016 Apr 13.

  PMID: 27076586 RESULT

MeSH Terms

Conditions

Dysphonia; Respiratory Aspiration

Interventions

Parathyroidectomy; Transplantation, Autologous

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Chang Huang-Chih, MD

  Co-host

  STUDY DIRECTOR

• Chen Jib-Bor, MD

  Co-host

  STUDY DIRECTOR

• Lai Chi-Chih, MD

  Co-host

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant professor

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: February 13, 2020
• Study Start: August 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)