Completed

Sinonasal Gas Exchange Dynamics The Aerodynamic Theory of the Sinonasal Interface

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Infections+4

+ Nose Diseases

+ Otorhinolaryngologic Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: August 2013
See protocol details

Summary

Principal SponsorLouisiana State University Health Sciences Center Shreveport
Last updated: August 20, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2013

Actual date on which the first participant was enrolled.

Sinonasal gas exchange is facilitated by the unique anatomy and topography of the sinonasal interface that represents a collection of airfoils creating an aerodynamic structure. The airflow during respiration generates positive and negative pressures that power the gas exchange between the sinuses and the nose. Major surgical alteration of the interface reduces the rate and velocity of the exchange. Minimally invasive procedures aimed at preserving the natural anatomy, topography and aerodynamic configuration of the interface will have negligible effects on sinonasal gas exchange.

Principal SponsorLouisiana State University Health Sciences Center Shreveport
Last updated: August 20, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsNose DiseasesOtorhinolaryngologic DiseasesParanasal Sinus DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsSinusitis

Criteria

Inclusion Criteria: Control: normal healthy adult volunteers ages 18-65, without allergies by history and allergy test, non-smoker, not using steroids. Study group 1: adult subjects who had maxillary sinus balloon sinuplasty (with intact uncinate and ethmoid complex) Study group 2: adult subjects who had endoscopic maxillary antrostomy and uncinectomy. Exclusion criteria: active acute or chronic infection, nasal polyps, severe nasal or septal deformity, cystic fibrosis, systemic illness (diabetes, hypertension etc.), vulnerable population (children, pregnant women, institutionalized individuals etc.) severe nasal and/or septal deviation, hypersensitivity or intolerance to study medications (topical and local anesthetics) any turbinate surgery.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

LSU Health ACC

Shreveport, United StatesOpen LSU Health ACC in Google Maps
CompletedOne Study Center