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Sinonasal Gas Exchange Dynamics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671098
First Posted: August 23, 2012
Last Update Posted: August 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anil Gungor MD, Louisiana State University Health Sciences Center Shreveport
  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:


Further study details as provided by Anil Gungor MD, Louisiana State University Health Sciences Center Shreveport:

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


Enrollment: 12
Study Start Date: August 2013
Study Completion Date: August 2015
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671098


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

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
First Submitted: August 20, 2012
First Posted: August 23, 2012
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Anil Gungor MD, 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