Sinonasal Gas Exchange Dynamics

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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: January 10, 2014
Last verified: January 2014

August 20, 2012
January 10, 2014
August 2013
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01671098 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Sinusitis
Not Provided
  • Control
    Healthy adults
  • Balloon Sinuplasty
    Patients who had balloon sinuplasty
  • FESS-Uncinectomy
    Patients who had FESS-Uncinectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact: Anil A Gungor, MD 3186756262 agungo@lsuhsc.edu
United States
 
NCT01671098
06301998
No
Anil Gungor MD, Louisiana State University Health Sciences Center Shreveport
Louisiana State University Health Sciences Center Shreveport
Not Provided
Principal Investigator: Anil A Gungor, MD Louisiana State University Health Sciences Center in New Orleans
Louisiana State University Health Sciences Center Shreveport
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP