Oto399711 891.893

Assessing the Efficacy of Tragal Pumping : A Randomized Controlled Trial
2011 144: 891 originally published online 18 February 2011 Otolaryngology -- Head and Neck Surgery The online version of this article can be found at: can be found at:
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Original Research—General Otolaryngology Assessing the Efficacy of Tragal Pumping: Otolaryngology—Head and NeckSurgery Foundation 2011Reprints and permission:sagepub.com/journalsPermissions.navDOI: 10.1177/0194599811399711http://otojournal.org Nathan H. Boyd, MD1, and Joshua A. Gottschall, MD1 No sponsorships or competing interests have been disclosed for this article.
pumping—the practice of pushing on the tragus to raisepressure within the external auditory canal (EAC)—is a commonly recommended adjunctive maneuver believed tofacilitate the introduction of ototopical medications into the Objective. Tragal pumping is the practice of pushing on the middle ear via a patent PET. Review of the medical litera- tragus to raise pressure in the external auditory canal. This ture revealed a small number of nonclinical studies support- is a study to determine if tragal pumping improves middle ing the efficacy of tragal pumping.3,4 No clinical studies ear penetration of ototopical medications via a patent pres- were found. This is a prospective, blinded, randomized con- trolled trial to determine if tragal pumping improves the Study Design. Prospective, randomized controlled trial.
middle ear penetration of ototopical medications.
Subjects and Methods. Children with chronic otitis media Children younger than 8 years of age scheduled for routine scheduled for routine placement of bilateral pressure equal- bilateral PET placement for chronic otitis media were ization tubes were offered enrollment in the study. After offered enrollment in the study (Figure 1). Patients with pressure equalization tube insertion, an otic preparation of stenotic ear canals, middle ear atelectasis, middle ear granu- 0.3% ofloxacin solution dyed with methylene blue was lation, or cholesteatoma were excluded from the study.
applied sequentially to both ear canals by the operating sur- Patients served as their own control, with 1 experimental geon. Tragal pumping was performed on the experimental and 1 control ear. The experimental ear was randomized by ear, and the opposite ear served as a control. A second coin flip. The EAC was dilated to the largest size aural operator, blinded to the randomization process, used an speculum possible, and a standard myringotomy was per- operating microscope to determine if otic drops had formed in the anterior-inferior quadrant. The middle ear was entered the middle ear as demonstrated by methylene blue aspirated and a Medtronic (Minneapolis, Minnesota) 1.27- mm fluoroplastic collar-button tube was placed. Four drops Results. Twenty-four patients with a mean age of 3.6 years of methylene blue–impregnated 0.3% ofloxacin otic solution were enrolled in the study. Middle ear penetration of otic (0.1 mL/5 mL) were placed in the ear canal without an drops was present in 33% (8/24) of control ears and in 75% aural speculum. On the experimental side, 4 tragal pumps (18/24) of experimental ears, resulting in a statistically signif- were performed. On the control side, 4 tragal pumps were simulated. A second operator, blinded to the randomizationprocess, suctioned the EAC and determined if the otic drops Conclusion. Tragal pumping improves the middle ear penetra- had entered the middle ear. A result was considered positive tion of ototopical medications via a patent pressure equal- if the promontory mucosa was stained with blue dye. P values were calculated with the McNemar test. This studywas approved by the Kaiser Permanente Northern California general otolaryngology, otitis media, pressure equalizationtubes, myringotomy, tragal pumping, ototopicals, otorrhea Received July 25, 2010; accepted January 12, 2011.
1Department of Head & Neck Surgery, Kaiser Permanente Medical Center, Otorrhea after pressure equalization tube (PET) Oakland,CA,USA insertion is a common complication with an incidence of 10% to 29% in some series to as high Nathan H. Boyd, MD, Kaiser Permanente Medical Center, Department of as 74% in others.1,2 Ototopical medications are the corner- Head & Neck Surgery, 280 W. MacArthur Blvd, Oakland, CA 94611, USA stone of treatment for PET-associated otorrhea. Tragal Otolaryngology–Head and Neck Surgery 144(6) resulted in a near 100% transmission rate of ototopicalsinto the middle ear.
The current study is the first to evaluate tragal pumping in vivo. Enrollment was limited to patients younger than 8years of age to control for age-related variations in auriculargrowth that could affect tragal pumping via changes in earcanal volume or soft tissue elasticity. Ofloxacin 3% oticsolution was chosen as the experimental ototopical agentbecause it is often prescribed for PET-related otorrhea andhas chemical properties that are representative of manyother ototopicals.
A direct comparison of control and experimental ears showed tragal pumping to significantly improve the penetra- Figure 1. Flow diagram demonstrating patient enrollment and tion of ototopicals into the middle ear (P = .0094).
progress in the randomized controlled trial.5 Although spontaneous middle ear penetration was noted in33% of control ears, tragal pumping increased penetrationto 75%. This result was further validated by examining cases in which the control and experimental ears differedwith respect to middle ear penetration of dye within the Twenty-four patients were enrolled in the study. The mean same individual (ie, the results were discordant). In all but 1 age of study participants was 3.6 years. Of the participants, case of discordance, it was the experimental ear that 62% (15/24) were male and 38% (9/24) were female.
resulted in middle ear penetration of dye. The NNT for the Middle ear penetration of otic drops was positive in 33% tragal pumping maneuver was calculated to be 3. This (8/24) of control ears and in 75% (18/24) of experimental ears, resulting in a statistically significant difference (P = otorrhea—administration of ear drops 2 times a day for 5 .0094, McNemar test). The number needed to treat (NNT) days (10 separate administrations of ototopicals)—tragal for the tragal pumping maneuver was calculated to be pumping will result in middle ear penetration in 3 or 4 3.0 6 1.5 to 6.2. Subset analysis was performed to evalu- applications that would not have otherwise occurred ate whether maximum speculum size (ie, ear canal size) or the presence of a middle ear effusion affected the efficacy One potential confounding factor was the potential for of tragal pumping. However, no such trend was noted.
ear drops to enter the middle ear via the myringotomy Results for a given patient were considered discordant rather than the PET. In certain cases, it was noted that the when the middle ear penetration of dye differed in the con- promontory was stained blue with no evidence of dye trol and experimental ears. Discordance was noted in 50% within the PET. This factor would tend to lessen the (12/24) of patients, and it was the experimental ear that observed effect of tragal pumping by creating false positives showed middle ear penetration of dye in 92% (11/12) of within the control group. Although our study did not specifi- cally look at clinical outcomes for treating PET-associatedotorrhea, it is reasonable to assume that improved middle ear penetration of ototopical medications is desirable and Surface tension in a hollow tube is inversely related to the tube’s radius. Standard PETs have a radius of about 1.3 The mechanism of action of tragal pumping may be mm, making surface tension a potentially formidable barri- inferred by the experimental data and real-time observations er to the passage of ototopical medications. Pashley and made with a rigid endoscope. Tragal pumping results in Scholl6 demonstrated in vitro that spontaneous passage of a rise in EAC pressure. The extent of this rise in pressure liquids through a PET occurs only after a significant pres- depends on the total volume of the EAC, the amount to sure gradient (11 cm of H2O) between the EAC and which this volume is reduced by tragal pumping, and the middle ear has been achieved. Multiple studies have con- elasticity of the surrounding tissues. In the presence of firmed this finding, although the pressure gradient needed a patent PET, the starting EAC volume includes the middle to promote passage of liquids through PETs has varied ear and mastoid spaces and is large. Tragal pumping does (0.1-60 cm of H2O) according to the liquid and in vitro not result in a significant rise in pressure within the EAC model employed.4,7-10 Saunders and Robinson10 demon- when the starting volume is large. However, when the PET strated that tragal pumping can create a pressure gradient is covered by a ‘‘puddle’’ of ototopical drops, the starting of up to 20 cm of H2O between the EAC and middle ear EAC volume is small, and tragal pumping results in a large and suggested that this would be sufficient to propel most rise in EAC pressure. As EAC pressure rises, it will either liquids through a PET. Hebert et al4 tested the efficacy of exceed the force of surface tension within the PET, propel- tragal pumping in vitro with a variety of common ototopi- ling the ototopical drops into the middle ear, or be dissipat- cals as well as plain and soapy water—tragal pumping ed into the soft tissues surrounding the EAC.
2. Myer CM. Post-tympanostomy tube otorrhea. Ear Nose Throat Tragal pumping significantly improves the middle ear pene- tration of ototopical medications via a patent PET. Tragal 3. Hebert RL, Vick ML, King GE, et al. Tympanostomy tubes pumping should be recommended to patients whenever oto- and otic suspensions: do they reach the middle ear space? topical medications are used for the treatment of tube- Otolaryngol Head Neck Surg. 2000;122:330-333.
4. Hebert RL, King GE, Bent JP. Tympanostomy tubes and water exposure: a practical model. Arch Otolaryngol Head Neck 5. Schulz KF, Altman DG, Moher D; CONSORT Group.
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allel group randomised trials. Ann Int Med. 2010;152:726-732.
Gottschall, study design, institutional review board application, 6. Pashley NRT, Scholl PD. Tympanostomy tubes and liquids: an data gathering, analysis, article editing.
in vitro study. J Otolaryngol. 1984;13:296-298.
7. Mills RP, Albizzati C, Todd AS. Ear drops and grommets.
8. Smith LP, Smullen JL, Younis RT. Differential penetration of 9. Arnold DJ, Bressler KL. Permeability of tympanotomy tubes in ototopical preparations. Otolaryngol Head Neck Surg. 1999;121:35-37.
1. Hochman J, Blakley B, Abdoh A, et al. Post-tympanostomy 10. Saunders MW, Robinson PJ. How easily do topical antibiotics tube otorrhea: a meta-analysis. Otolaryngol Head Neck Surg.
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