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Sinonasal Gas Exchange Dynamics

This study is not yet open for participant recruitment.
Verified April 2013 by Louisiana State University Health Sciences Center Shreveport
Sponsor:
Information provided by (Responsible Party):
Anil Gungor MD, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT01671098
First received: August 20, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Sinusitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sinonasal Gas Exchange Dynamics The Aerodynamic Theory of the Sinonasal Interface

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Further study details as provided by Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • Sinonasal gas exchange rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • NO production rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    ANALYZE AND DEFINE NITRIC OXIDE PRODUCTION RATE AND VARIABLES IN NORMAL AND SURGICALLY ALTERED MAXILLARY SINUSES


Estimated Enrollment: 45
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Healthy adults
Balloon Sinuplasty
Patients who had balloon sinuplasty
FESS-Uncinectomy
Patients who had FESS-Uncinectomy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671098

Contacts
Contact: Anil A Gungor, MD 3186756262 agungo@lsuhsc.edu

Locations
United States, Louisiana
LSU Not yet recruiting
Shreveport, Louisiana, United States, 71130
Sub-Investigator: Stewart Little, MD            
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Investigators
Principal Investigator: Anil A Gungor, MD Louisiana State University Health Sciences Center in New Orleans
  More Information

No publications provided

Responsible Party: Anil Gungor MD, Associate Professor, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT01671098     History of Changes
Other Study ID Numbers: 06301998
Study First Received: August 20, 2012
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Louisiana State University Health Sciences Center Shreveport:
nitric oxide
sinuplasty

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013