Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy

NCT04581174 | Completed

• 1 other identifier: FNO-ENT-turbinates_hypertrophy
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 3

Brief Summary

The study examines the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy.

Conditions

Inferior Nasal Turbinate Hypertrophy; Extraesophageal Reflux

Keywords

Inferior nasal turbinate hypertrophy; Extraesophageal reflux; Oropharyngeal pH monitoring; Restech system

Outcome Measures

Primary Outcomes (1)

• Severity of extraesophageal reflux using oropharyngeal pH monitoring

  The primary outcome measure of the study is to examine the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy, assessed on the RYAN score.

  24 hours

Study Arms (4)

1st degree of hypertrophy according to Camacho

EXPERIMENTAL

Patients with 1st degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.

Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated

2nd degree of hypertrophy according to Camacho

EXPERIMENTAL

Patients with 2nd degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.

Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated

3rd degree of hypertrophy according to Camacho

EXPERIMENTAL

Patients with 3rd degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.

Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated

4th degree of hypertrophy according to Camacho

EXPERIMENTAL

Patients with 4th degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.

Diagnostic Test: 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated

Interventions

24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated DIAGNOSTIC_TEST

Patients with the 1st degree of hypertrophy according to Camacho, 2nd degree of hypertrophy according to Camacho, 3rd degree of hypertrophy according to Camacho, 4th degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values \<5.5 will be evaluated.

1st degree of hypertrophy according to Camacho; 2nd degree of hypertrophy according to Camacho; 3rd degree of hypertrophy according to Camacho; 4th degree of hypertrophy according to Camacho

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-80 years
• patients indicated for oropharyngeal pH-metry (Restech) with suspected extraesophageal reflux
• patients with 2nd - 4th degree hypertrophy of the lower turbinates (according to Camacho Classification)

You may not qualify if:

• patients with chronic rhinosinusitis with polyps
• patients who have had an acute upper respiratory tract infection in the last 8 weeks
• patients after previous surgery in the nasal cavity and nasopharynx
• patients after radiotherapy in the head and neck area
• non tolerance of pH catheter

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University Hospital Bratislava: collaborator
• Fortmedica Prague: collaborator

Study Sites (3)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Fortmedica Prague

Prague, 14300, Czechia

Location

Comenius University, University Hospital Bratislava

Bratislava, 85107, Slovakia

Location

Related Publications (7)

• Camacho M, Zaghi S, Certal V, Abdullatif J, Means C, Acevedo J, Liu S, Brietzke SE, Kushida CA, Capasso R. Inferior turbinate classification system, grades 1 to 4: development and validation study. Laryngoscope. 2015 Feb;125(2):296-302. doi: 10.1002/lary.24923. Epub 2014 Sep 12.

  PMID: 25215619 BACKGROUND

• Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.

  PMID: 17216738 BACKGROUND

• Camacho M, Zaghi S, Certal V, Abdullatif J, Modi R, Sridhara S, Tolisano AM, Chang ET, Cable BB, Capasso R. Predictors of Nasal Obstruction: Quantification and Assessment Using Multiple Grading Scales. Plast Surg Int. 2016;2016:6945297. doi: 10.1155/2016/6945297. Epub 2016 May 16.

  PMID: 27293885 BACKGROUND

• Ayazi S, Lipham JC, Hagen JA, Tang AL, Zehetner J, Leers JM, Oezcelik A, Abate E, Banki F, DeMeester SR, DeMeester TR. A new technique for measurement of pharyngeal pH: normal values and discriminating pH threshold. J Gastrointest Surg. 2009 Aug;13(8):1422-9. doi: 10.1007/s11605-009-0915-6. Epub 2009 May 7.

  PMID: 19421822 BACKGROUND

• Chheda NN, Seybt MW, Schade RR, Postma GN. Normal values for pharyngeal pH monitoring. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):166-71. doi: 10.1177/000348940911800302.

  PMID: 19374146 BACKGROUND

• Wiener GJ, Tsukashima R, Kelly C, Wolf E, Schmeltzer M, Bankert C, Fisk L, Vaezi M. Oropharyngeal pH monitoring for the detection of liquid and aerosolized supraesophageal gastric reflux. J Voice. 2009 Jul;23(4):498-504. doi: 10.1016/j.jvoice.2007.12.005. Epub 2008 May 12.

  PMID: 18468849 BACKGROUND

• Zelenik K, Matousek P, Formanek M, Urban O, Kominek P. Patients with chronic rhinosinusitis and simultaneous bronchial asthma suffer from significant extraesophageal reflux. Int Forum Allergy Rhinol. 2015 Oct;5(10):944-9. doi: 10.1002/alr.21560. Epub 2015 Jun 5.

  PMID: 26046448 BACKGROUND

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karol Zeleník, Ass.Prof.,MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking is being used in this study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be enrolled to a total of four study arms, depending on the degree of inferior turbinates hypertrophy (according to Camacho)

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 9, 2020
• Study Start: October 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1); CZ (2)