SinusitisNCT01671098
Sinonasal Gas Exchange Dynamics
An observational study of Sinusitis, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinusitis
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients who had balloon sinuplasty of traditional endoscopic uncinectomy for treatment of chronic maxillary sinusitis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sinusitis
- Keywords
- nitric oxide, sinuplasty
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy adults | |
| Balloon Sinuplasty | Patients who had balloon sinuplasty | |
| FESS-Uncinectomy | Patients who had FESS-Uncinectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinonasal gas exchange rate
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.
Measured: 2 years
Secondary outcomes (1)
NO production rate
ANALYZE AND DEFINE NITRIC OXIDE PRODUCTION RATE AND VARIABLES IN NORMAL AND SURGICALLY ALTERED MAXILLARY SINUSES
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Gungor MD, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Anil A Gungor, MD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671098
- Sponsor's protocol ID
- 06301998
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2012
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinonasal Gas Exchange Dynamics The Aerodynamic Theory of the Sinonasal Interface
- ClinicalTrials.gov ID
- NCT01671098
- Acronym / sponsor ID
- 06301998
- Conditions
- Sinusitis
- Keywords
- nitric oxide, sinuplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy adults |
| Balloon Sinuplasty | – | –Patients who had balloon sinuplasty |
| FESS-Uncinectomy | – | –Patients who had FESS-Uncinectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who had balloon sinuplasty of traditional endoscopic uncinectomy for treatment of chronic maxillary sinusitis
Key inclusion criteria (5 listed)
- Control:
- 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.
Key exclusion criteria (8 listed)
- active acute or chronic infection,
- nasal polyps,
- severe nasal or septal deformity,
- cystic fibrosis,
- systemic illness (diabetes, hypertension etc.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
NO production rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil A Gungor, MD principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinonasal gas exchange rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.