Sinonasal Gas Exchange Dynamics

Sinusitis Clinical Trial

Official title:

Sinonasal Gas Exchange Dynamics The Aerodynamic Theory of the Sinonasal Interface

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671098
• Other study ID #: 06301998
• Status: Completed
• Phase: N/A
• First received: August 20, 2012
• Last updated: August 18, 2015
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Louisiana State University Health Sciences Center Shreveport
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sinusitis

Locations

Country	Name	City	State
United States	LSU Health ACC	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center Shreveport

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	NO production rate	ANALYZE AND DEFINE NITRIC OXIDE PRODUCTION RATE AND VARIABLES IN NORMAL AND SURGICALLY ALTERED MAXILLARY SINUSES	2 years	No