The Distribution of Normal Saline Delivered by Large-Particle Nasal Nebulizer versus Large-Volume/Low-Pressure Squeeze Bottle

November 28, 2010

Rhinologists at the Texas Sinus Institute of the Department of Otorhinolaryngology-Head and Neck Surgery at The University of Texas Medical School at Houston and Memorial Hermann-Texas Medical Center are engaged in research efforts that drive the innovation that provides tomorrow’s advances. The following report was presented at the 56th Annual Meeting of the American Rhinologic Society, held in Boston on September 25, 2010.

Implicit in the increasing interest in the topical administration of medications for postoperative treatment of chronic rhinosinusitis (CRS) is the assumption that the numerous devices available deliver the agent effectively.  “But the information we have about whether medications are actually reaching the paranasal sinuses is slim,” says Martin J. Citardi, MD, who is professor and chair of the Department of Otorhinolaryngology-Head and Neck Surgery at The University of Texas Medical School at Houston and chief of otorhinolaryngology at Memorial Hermann-Texas Medical Center and  “Our goal in this study was to assess the distribution patterns of MedInvent’s Nasoneb 9070 large-particle nasal nebulizer (LPNN) and a widely accepted large-volume/low-pressure squeeze bottle called Sinus Rinse, produced by Neil Med Pharmaceuticals.” The study was begun at the end of November 2009; data analysis was completed in the spring of 2010.

The researchers selected fluorescein, a fluorescent yellow dye, as a marker for both arms of the study.  Trial 1 was a test run of LPNN, followed by delivery of fluorescein-saline solution by LPNN.  Trial 2 used the same fluorescein-saline solution delivered by the large-volume/low-pressure (LVLP) squeeze bottle.  Nasal endoscopy was performed before and after each trial for comparison.  The study was completed under the auspices of UTHealth’s Texas Sinus Institute.

Ten patients completed both trials, providing 18 sides for review.  “Both devices delivered dye into all areas of the nose and paranasal sinuses,” Dr. Citardi says.  “We videotaped each examination and asked a panel of four reviewers to score the distribution of the fluorescein, looking for patterns showing concentrations of the marker in relation to the volume delivered.  Each reviewer recorded a similar score at each site for each patient.”

The researchers concluded that both the large-particle nasal nebulizer and the large-volume/low-pressure squeeze bottle achieved good sinus penetration, with no significant difference between LPNN and LVLP at all sites.  “From the delivery patterns, we developed the notion that LPNN is probably the better choice for high concentrations of the agent delivered in low volumes, while LVLP is probably the better choice for large volumes of the agent at low concentrations,” Dr. Citardi says.  The investigators also noted that LVLP may provide greater delivery at the frontal recess.

“We also learned that endoscopic assessment of dilute fluorescein solutions is a practical way to assess intrasinus drug delivery,” he says.  “It proved to be reliable, and all 10 patients tolerated it well.”

Drs. Citardi, Fakhri and Luong are the core physicians for the Texas Sinus Institute. For more information, visit www.texassinus.rog.

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