Sinonasal Gas Exchange Dynamics

Sinonasal Gas Exchange Dynamics The Aerodynamic Theory of the Sinonasal Interface

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01671098

Enrollment

Registered

2012-08-23

Start date

2013-08-31

Completion date

2015-08-31

Last updated

2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis

Keywords

nitric oxide, sinuplasty

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Sinonasal gas exchange rate	2 years	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.

Secondary

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

Countries

United States

Outcome results