Linear versus Turbulent Airflow Tracheostomy Heat and Moisture Exchangers: A Crossover Study.

OBJECTIVE: This study aimed to evaluate the impact of two tracheostomy heat and moisture exchangers (HMEs), namely the Shikani Oxygen HME™ (S-O2 HME, ball type, turbulent airflow) and Mallinckrodt Tracheolife II DAR HME (M-O2 HME; flapper type, linear airflow) on tracheobronchial mucosal health, oxygenation, humidification, and patient preference. METHODS: A randomized cross-over study was conducted with HME-naïve long-term tracheostomy subjects at two academic medical centers. Bronchoscopy assessments of mucosal health were performed at baseline and day 5 of HME application, along with oxygen saturation (SpO2 ) and breathed air humidity at four oxygen flow rates (1, 2, 3, and 5 lpm). Patient preference was assessed on study conclusion. RESULTS: Both HMEs were associated with improved mucosal inflammation and decreased mucus production (p < 0.0002), with greater improvements in the S-O2 HME group (p < 0.007). Both HMEs improved humidity concentration at each oxygen flow rate (p < 0.0001), without significant differences between groups. SpO2 was greater for the S-O2 HME versus the M-O2 HME across all measured oxygen flow rates (p = 0.003). At low oxygen flow rates (1 or 2 lpm), the SpO2 in the S-O2 HME group was similar to that of the M-O2 HME at higher oxygen flow rates (3 or 5 lpm; p = 0.6). Ninety percent of subjects preferred the S-O2 HME. CONCLUSION: Tracheostomy HME uses correlated with improved indicators of tracheobronchial mucosal health, humidity, and oxygenation. The S-O2 HME outperformed the M-O2 HME with respect to tracheobronchial inflammation, SpO2 , and patient preference. Regular HME use by tracheostomy patients is recommended to optimize pulmonary health. Newer ball-type speaking valve technology additionally allows concomitant HME and speaking valve application. LEVEL OF EVIDENCE: 2 Laryngoscope, 133:3422-3428, 2023.

The Shikani HME: A New Tracheostomy Heat and Moisture Exchanger.

Purpose Tracheostomy patients face many adversities including loss of phonation and essential airway functions including air filtering, warming, and humidification. Heat and moisture exchangers (HMEs) facilitate humidification and filtering of inspired air. The Shikani HME (S-HME) is a novel turbulent airflow HME that may be used in-line with the Shikani Speaking Valve (SSV), allowing for uniquely preserved phonation during humidification. The aims of this study were to (a) compare the airflow resistance (R airflow) and humidification efficiency of the S-HME and the Mallinckrodt Tracheolife II tracheostomy HME (M-HME) when dry (time zero) and wet (after 24 hr) and (b) determine if in-line application of the S-HME with a tracheostomy speaking valve significantly increases R airflow over a tracheostomy speaking valve alone (whether SSV or Passy Muir Valve [PMV]). Method A prospective observational ex vivo study was conducted using a pneumotachometer lung simulation unit to measure airflow (Q) amplitude and R airflow, as indicated by a pressure drop (P Drop) across the device (S-HME, M-HME, SSV + S-HME, and PMV). Additionally, P Drop was studied for the S-HME and M-HME when dry at time zero (T0) and after 24 hr of moisture testing (T24) at Q of 0.5, 1, and 1.5 L/s. Results R airflow was significantly less for the S-HME than M-HME (T0 and T24). R airflow of the SSV + S-HME in series did not significant increase R airflow over the SSV or PMV alone. Moisture loss efficiency trended toward greater efficiency for the S-HME; however, the difference was not statistically significant. Conclusions The turbulent flow S-HME provides heat and moisture exchange with similar or greater efficacy than the widely used laminar airflow M-HME, but with significantly lower resistance. The S-HME also allows the innovative advantage of in-line use with the SSV, hence allowing concurrent humidification and phonation during application, without having to manipulate either device.

Topical therapy for refractory rhinosinusitis caused by methicillin-resistant Staphylococcus aureus: First report in a prospective series.

OBJECTIVE: The incidence of refractory chronic rhinosinusitis (CRS) associated with methicillin-resistant Staphylococcus aureus (MRSA) is rising and remains a therapeutic challenge. The goal of this study is to demonstrate the efficacy of a non-invasive topical therapy against MRSA in these patients. METHODS: Seventeen patients with refractory CRS caused by MRSA were treated with a topical therapy protocol. Treatment consisted of weekly endoscopic sinus debridement followed by intra-sinus installation of a hydroxyl-ethylcellulose gel that releases mometasone and a culture-directed antibiotic for a period of 6 weeks, along with daily nasal nebulization of mometasone with the same antibiotic and saline rinses. Clinical outcome was assessed using the Lund-Kennedy (LK) symptom and endoscopic appearance scores. Sinus mucosal tissue was homogenized and cultured, and microbial biofilm burden was assessed based on colony forming units (CFUs) counts. RESULTS: Rhinotopic therapy resulted in clearance of MRSA in 13 of 16 patients (81.2%). Treated patients also demonstrated significant improvement clinically as measured by the LK scores. In addition, a significant decrease in mucosal CFUs was observed post-therapy. CONCLUSION: Our findings demonstrate that topical therapy is an effective method for treating MRSA-associated refractory CRS.

Experimental Assessment and Future Applications of the Shikani Tracheostomy Speaking Valve.

PURPOSE: Tracheostomy speaking valve use may increase airflow resistance and work of breathing. It remains unclear which valve offers the best performance characteristics. We compared the performance characteristics of the Shikani speaking valve (SSV; unidirectional-flow ball valve) with those of the Passy-Muir valve (PMV; bias-closed flapper valve). METHOD: Airflow resistance was measured for both the SSV and the PMV at 8 flow amplitudes and in 3 orientations (-15°, 0°, +20°) in the bias-open and bias-closed configurations. RESULTS: Significantly lower airflow resistance was observed for the SSV (bias open) compared with the PMV at -15° (p < .001), 0° (p < .001), and +20° (p = .006) from the horizon. No significant difference was observed between the PMV and the SSV (bias-closed) configuration at any of the tested angles. A nonsignificant trend toward decreased airflow resistance was observed between the SSV bias-open and bias-closed configurations at each of the angles tested. CONCLUSIONS: The SSV demonstrated lower airflow resistance compared with the PMV across 8 flow amplitudes in the bias-open configuration at -15°, 0°, and +20° from the horizon. Further investigation is needed to determine the clinical impact of these findings on patient comfort, work of breathing, phonation, and airway protection during swallowing.

Patents and Recent Innovations in Topical Membrane Therapy of Refractory Rhinosinusitis.

Chronic Rhinosinusitis (CRS), one of the commonest chronic inflammatory disorders, is encountered daily in all healthcare settings. In its refractory form, CRS seems to prevail over most up-to-date surgical interventions and systemic medical remedies, owing to our poor understanding of its perplexing pathophysiology. Although several systemic influences impinge on the progression of inflammation, the true interplay between offensive and defensive factors takes place on-site, i.e. across the sinonasal epithelial coating. Therefore, current treatment strategies shift the weight of CRS management toward topical modalities, which combine the benefits of surgical approach with the healing effect of conventional medications. An explosive emergence of relevant patents is still in progress, emphasizing the need for classification and comparison. Novel delivery methods of medications into the sinus cavities include modifications of traditional rinses, state-of-the-art nebulizing devices, and the revolutionary concept of sustained drug application utilizing carrier gels or nasal implants. As far as the introduction of new medications is concerned, recent patents propose alterations to the physical and chemical properties of irrigating solutions, as well as the local use of antiseptics, hydragogues, and anti-biofilm agents. This review focuses on the local pathophysiologic events of CRS and the most exciting innovations regarding its topical management.

Rhinotopic therapy for refractory chronic rhinosinusitis: a study of 20 cases.

The management of refractory chronic rhinosinusitis (CRS) after endoscopic sinus surgery is complex and challenging. We conducted a prospective clinical pilot study to evaluate the effectiveness of a rhinotopic protocol for the treatment of refractory CRS. Our study population was made up of 20 patients--8 men and 12 women, aged 31 to 76 years (mean: 50.1)--who were treated in our tertiary care rhinology fellowship training program. The rhinotopic protocol consisted of twice-daily saline rinses, each of which was followed by the administration of a nebulized corticosteroid and then a nebulized antibiotic. This regimen was administered for 6 weeks. Thereafter, patients underwent a once-weekly endoscopic sinus debridement followed by topical intrasinus installation of a corticosteroid and antibiotic. The duration of follow-up was 24 weeks, and thus the total study duration was 30 weeks. Treatment outcomes were based on Lund-Kennedy symptom scores and Lund-Kennedy endoscopic appearance scores. We found a 56% improvement in the mean symptom score after 3 weeks of therapy and 77% after 6 weeks. Subsequent follow-up revealed 90% improvement 4 weeks following the completion of therapy and 95% at 8 weeks post-therapy. Thereafter, we saw a small decrease in improvement: 73% at 16 weeks of follow-up and 65% at 24 weeks. Analysis of endoscopic appearance scores revealed a 55% improvement at 3 weeks of therapy and 84% at 6 weeks. The same general pattern emerged during follow-up, with 94% improvement 4 weeks after the cessation of therapy, 96% at 8 weeks, 76% at 16 weeks, and 75% at 24 weeks. Sinus cultures performed 4 weeks after the cessation of therapy found no growth in 13 patients (65%), normal respiratory flora in 5 patients (25%), a persistent pathogen in 1 patient (5%), and the emergence of a new pathogen in another (5%). Analysis of symptom scores and endoscopic appearance scores revealed that the rhinotopic protocol resulted in statistically significant improvement (p < 0.001) throughout the treatment period and follow-up period, although the improvement gradually declined over time. We therefore conclude that a rhinotopic protocol can be an effective treatment for refractory CRS.

Mucosal expression of aquaporin 5 and epithelial barrier proteins in chronic rhinosinusitis with and without nasal polyps.

OBJECTIVES: The purpose of this study is to characterize the association between altered epithelial barrier function, represented by changes in histology and differential expression of the mucosal water membrane permeability protein aquaporin 5 (AQP5), and the pathophysiology of chronic refractory sinusitis (CRS) in patients with and without nasal polyposis. STUDY DESIGN: Prospective clinical study. SETTING: Tertiary rhinology referral center. PARTICIPANTS: Sinonasal samples were obtained from seven CRS subjects with nasal polyps (CRSwNP), seven CRS without nasal polyposis (CRSsNP), and five control healthy patients. METHODS: Mucosal membrane changes were evaluated through hematoxylin and eosin staining of the membrane barrier and immunohistochemical staining of AQP5 expression, a membrane channel protein that affects trans-epithelial water permeability and tissue edema. AQP5 expression was confirmed by real-time PCR (rt-PCR) and western blot. Levels of other membrane proteins, including E-cadherin and Septin-2, were also assessed. RESULTS: CRSwNP patients showed substantial histologic evidence of membrane remodeling with increased edema and glandular hyperplasia. The epithelial expression of AQP5 was significantly lower in CRSwNP as compared to CRSsNP or control. There was no significant difference in the expression of E-cadherin and Septin-2. CONCLUSIONS: Collectively, these data suggest that the mucosal epithelial barrier is compromised in the context of CRS (predominantly in CRSwNP) when compared to control and that AQP5 acts as a key tight junction protein in the maintenance of mucosal water homeostasis. We hypothesize that AQP5 plays a possible role in the pathophysiology of mucosal edema and polyp formation.

Topical gel therapy for sinonasal polyposis in Samter's triad: preliminary report.

OBJECTIVES: Rhinosinusitis and polyposis are difficult to treat in patients with Samter's triad; they commonly recur despite sinus surgery, antibiotics, and/or nasal steroids. The present study assesses the efficacy of a multimodal regimen that includes topical corticosteroids and antibiotics delivered through a hydroxyethyl cellulose gel and by nebulization. METHODS: Eleven patients with Samter's triad who had polyposis and rhinosinusitis that recurred despite endoscopic sinus surgery were treated with a 6-week course of multimodal topical therapy consisting of a hydroxyethyl cellulose gel that releases corticosteroids and antibiotics, topical nebulization of corticosteroids and antibiotics, saline solution rinses, and sinus debridement. Clinical outcomes were evaluated by Lund-Kennedy endoscopic and symptom scores. Histologic assessment was evaluated by hematoxylin and eosin staining before and after treatment. RESULTS: Both Lund-Kennedy symptom and endoscopic scores showed.a progressive and statistically significant decline throughout the course of treatment, reaching at 6 weeks 42% of the pretreatment values (p = 0.005) for the Lund-Kennedy symptom score and 34% (p = 0.002) for the endoscopic score, respectively; however, the significance of the improvement was lost with time. CONCLUSIONS: Topical gel therapy improves clinical symptoms, endoscopic findings, and sinus membrane histologic features in patients with refractory Samter's triad, but the improvement is transient, suggesting that a longer therapeutic period might be needed.

Comparison of speech parameters and olfaction using different tracheotomy speaking valves.

BACKGROUND: The objective of this work was to obtain a controlled subjective and objective in vivo clinical comparison of the Passy-Muir, Shiley, and Ball speaking valves. METHODS: Ten patients free of laryngeal pathology but dependent on tracheotomy for respiration were tested with each of the speaking valves. Olfaction was assessed for each patient using the University of Pennsylvania Smell Identification Test (UPSIT). Acoustic and perceptual analyses included subjective assessments, noninstrumental objective assessments (including maximum phonation time, and S:Z ratio), and instrumental objective assessments (including fundamental frequency:maximum phonation range, vocal intensity, perturbation, naturalness, and turbulence). Oxygen saturation was assessed by pulse oximetry. RESULTS: There was a highly significant statistical difference in olfaction and speech naturalness, in favor of the Ball valve (The Airway Company, Forest Hill, MD). The Ball valve's speech parameters were generally better than with the Passy-Muir and Shiley valves, including maximum phonation, S:Z ratio, jitter, noise, and turbulence, although the differences were not statistically significant. There were no differences among the valves in oxygen saturation levels. CONCLUSION: This study illustrates that olfaction and certain speech parameters, most noticeably speech naturalness, are significantly improved with the Ball valve as compared to the Passy-Muir and Shiley valves.

Endoscopically guided chitosan nasal packing for intractable epistaxis.

BACKGROUND: The purpose of this study was to evaluate the effectiveness and safety of endoscopically guided chitosan packing in controlling intractable epistaxis. A prospective case series was performed. METHODS: This is a prospective clinical study conducted in a tertiary rhinology fellowship training hospital between January 2009 and November 2009. The study population consisted of patients with intractable epistaxis that failed to respond to traditional anterior-posterior nasal packing using either a 10-cm Pope PVA Merocel or a Rapid-Rhino. The bleeding site was identified using a nasal endoscope and controlled using a pack made of a ChitoFlex chitosan dressing wrapped around a polyvinyl acetal nasal sponge. RESULTS: The intent-to-treat population consisted of 20 severe epistaxis subjects (8 men and 12 women) who continued to bleed despite traditional anterior-posterior nasal packing. The mean age was 67 years (±19 years). Sixteen subjects were on antiplatelets and/or anticoagulants. Eleven subjects (55%) presented with anterior epistaxis, and 7 subjects (35%) presented with posterior epistaxis. Chitosan nasal packing was performed on an outpatient basis and resulted in effective and immediate hemostasis in 19/20 subjects (95%). One subject had persistent bleeding after the first packing attempt and was successfully repacked within 30 minutes. Time to complete cessation of bleeding was 3.6 ± 2.2 minutes in the 19 subjects; the pack was removed after 48 hours, without any evidence of rebleeding or any serious side effects. CONCLUSION: Endoscopically guided chitosan packing is a safe, effective, and well-tolerated outpatient treatment for the management of intractable epistaxis.

Propagation of human nasal chondrocytes in microcarrier spinner culture.

OBJECTIVE: The aim of this study was to test the effectiveness of nasal septal chondrocytes, propagated in microcarrier spinner culture, as an alternative tissue source of chondrocytic cells for cartilage grafts for head and neck surgery and for articular cartilage repair. METHODS: We harvested chondrocytes from 159 patients, ranging in age from 15 to 80 years and undergoing repair of a deviated nasal septum, and propagated the cells in a microcarrier spinner culture system. The nasal chondrocytes proliferated and produced extracellular matrix components similar to that produced by articular chondrocytes. RESULTS: In microcarrier spinner culture on collagen beads, chondrocyte numbers increased up to 14-fold in 2 weeks. After a month, the microcarriers seeded with nasal chondrocytes began to aggregate, producing a dense cartilage-like material. The newly synthesized extracellular matrix was rich in high molecular weight proteoglycans, and the chondrocytes expressed type II collagen and aggrecan but not type I collagen. CONCLUSION: These studies support the feasibility of engineering cartilage tissue using chondrocytes harvested from the nasal septum. Injectable and solid formulations based on this technology are being evaluated for applications in craniomaxillofacial reconstructive surgery and for plastic and orthopedic surgery practices.