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Completed

NCT Number: NCT01671098

Sinonasal Gas Exchange Dynamics

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.

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LSU Health ACC

Shreveport, Louisiana, 71130, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. NO production rate

    Time frame: 2 years

    ANALYZE AND DEFINE NITRIC OXIDE PRODUCTION RATE AND VARIABLES IN NORMAL AND SURGICALLY ALTERED MAXILLARY SINUSES

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center Shreveport

Other

Registry information

Official study title

Sinonasal Gas Exchange Dynamics The Aerodynamic Theory of the Sinonasal Interface

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2012
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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