Sinonasal Gas Exchange Dynamics

Sinonasal Gas Exchange Dynamics The Aerodynamic Theory of the Sinonasal Interface

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.

Study Overview

• Status: Completed
• Conditions: Sinusitis

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71130
      • LSU Health ACC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who had balloon sinuplasty of traditional endoscopic uncinectomy for treatment of chronic maxillary sinusitis

Description

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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Control; Healthy adults
Balloon Sinuplasty; Patients who had balloon sinuplasty
FESS-Uncinectomy; Patients who had FESS-Uncinectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sinonasal gas exchange rate	ANALYZE AND DEFINE GAS EXCHANGE PATTERNS IN THE MAXILLARY SINUS DURING NASAL RESPIRATION IN NORMAL SINUSES AND COMPARE WITH SURGICALLY MODIFIED SUBJECTS THAT WILL INCLUDE MAXILLARY SINUSES AFTER ENDOSCOPIC SINUS SURGERY AND BALLOON SINUPLASTY.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NO production rate	ANALYZE AND DEFINE NITRIC OXIDE PRODUCTION RATE AND VARIABLES IN NORMAL AND SURGICALLY ALTERED MAXILLARY SINUSES	2 years

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center Shreveport
• Investigators: Principal Investigator: Anil A Gungor, MD, Louisiana State University Health Sciences Center in New Orleans

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (ESTIMATE): August 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: nitric oxide; sinuplasty
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: 06301998