Preoperative laboratory measurements as a predictor for nasal steroid irrigations after sinus surgery for chronic rhinosinusitis with nasal polyps.

PURPOSE: To assess whether preoperative C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), immunoglobulin E (IgE), and blood eosinophil percentage (EOS) can predict need for steroid irrigations after FESS. MATERIALS AND METHODS: Adult patients at BIDMC from inception until September 8, 2023 with chronic rhinosinusitis with nasal polyps who underwent FESS and had preoperative CRP (n = 129), ESR (n = 79), IgE (n = 107), or EOS (n = 125) were included. Labs were divided into normal (CRP: 0-5.0 mg/L; ESR: 0-15 mm/h; IgE: 150-300Ul/mL; EOS: 1-7 %) and high groups (CRP: >5.0 mg/L; ESR: >15 mm/h; IgE: >300Ul/mL; EOS: >7 %). The primary outcome was need for intranasal steroid irrigations after FESS (≤4 weeks, 4-12 weeks, 12-26 weeks, 26-52 weeks, 1-3 years, 3-5 years, and > 5 years). Receiver operating characteristic curves were created to determine thresholds for predicting postoperative steroid irrigations. RESULTS: Elevated IgE required intranasal steroid irrigation at 1-3 years (normal 34 %, high 62 %, p = 0.02), 3-5 years (normal 24 %, high 48 %, p = 0.04), and > 5 years (normal 19 %, high 43 %, p = 0.02). Elevated EOS required intranasal steroid irrigation at 26-52 weeks (normal 7 %, high 25 %, p = 0.009) and > 5 years (normal 19 %, high 46 %, p = 0.005). The area under the curve for IgE at 1-3 years was 0.696 (95 % CI: 0.597-0.795) with cutoff at 144-148 Ul/mL. CRP and ESR were not predictive of postoperative intranasal steroid treatment. CONCLUSIONS: Elevated IgE and EOS (but not CRP or ESR) may predict need for intranasal steroid treatment after FESS.

Evaluating the efficacy of nasal irrigation in postoperative functional endoscopic sinus surgery patients: a systematic review and meta-analysis.

PURPOSE: Functional endoscopic sinus surgery (FESS) is a mainstay surgical intervention for chronic rhinosinusitis with nasal polyposis (CRSwNP). Nasal irrigation, particularly with normal saline, is a widely recommended postoperative care modality. This systematic review and meta-analysis aimed to assess the efficacy of various nasal irrigation solutions in postoperative FESS patients. METHODS: A comprehensive search was conducted in multiple databases for randomized controlled trials investigating normal saline and various substances for nasal irrigation post-FESS. The systematic review followed PRISMA guidelines, and the meta-analysis used R software for data synthesis. Outcome measures included SNOT-22 and LKES scores. The Cochrane tool was employed to evaluate the potential for bias. RESULTS: Results from 14 studies, focusing on six each for SNOT-22 and LKES, revealed a significant reduction in symptoms and endoscopic scores with various solutions compared to normal saline. The meta-analysis using the random-effects model indicated a negative standardized mean difference (SMD) of - 0.69(95% CI [- 1.64; 0.27], p = 0.157) for symptoms and endoscopic scores (SMD = - 0.48, 95% CI [- 1.32; 0.36], z = - 1.12, p = 0.264). Subgroup analyses highlighted budesonide's efficacy over normal saline, but substantial heterogeneity and potential publication bias were noted. CONCLUSION: Nasal irrigation with various solutions postoperative FESS patients demonstrated significant improvements in patient-reported symptoms and endoscopic scores compared to normal saline. Budesonide appeared particularly effective. However, high heterogeneity and potential publication bias warrant cautious interpretation. Standardized outcome measures and further research are needed to strengthen the evidence.

Seawater nasal wash to reduce symptom duration and viral load in COVID-19 and upper respiratory tract infections: a randomized controlled multicenter trial.

PURPOSE: The objective was to assess the efficacy of seawater nasal wash on symptom duration, intranasal viral load, household transmission in COVID-19 and URTIs. METHODS: This prospective, randomized, controlled, multicentric, parallel study included 355 mild/moderate COVID-19 and URTI adults with rhinologic symptoms ≤ 48h. Active group performed 4-daily nasal washes with undiluted isotonic seawater versus control group (without nasal wash). Symptoms were self-assessed daily using the WURSS-21 questionnaire for 3 weeks. Viral load was measured by RT-PCR on nasopharyngeal swabs collected on Day 0, Day 5, Day 14 and Day 21. Digital droplet PCR was additionally performed for SARS-CoV-2. RESULTS: Overall COVID-19 subjects recovered earlier the ability to accomplish daily activities in the active group (- 1.6 day, p = 0.0487) with earlier improvement of taste (- 2 days, p = 0.0404). COVID-19 subjects with severe nasal symptoms at D0 showed the earliest resolution of anosmia (- 5.2 days, p = 0.0281), post-nasal drip (- 4.1 days, p = 0.0102), face pain/heaviness (- 4.5 days, p = 0.0078), headache (- 3.1 days, p = 0.0195), sore throat (- 3.3 days, p = 0.0319), dyspnea (- 3.1 days, p = 0.0195), chest congestion (- 2.8 days, p = 0.0386) and loss of appetite (- 4.5 days, p = 0.0186) with nasal wash. In URTIs subjects, an earlier resolution of rhinorrhea (- 3.5 days, p = 0.0370), post-nasal drip (- 3.7 days, p = 0.0378), and overall sickness (- 4.3 days, p = 0.0248) was reported with nasal wash. Evolution towards more severe COVID-19 was lower in active vs control, with earlier viral load reduction in youngest subjects (≥ 1.5log10 copies/10000 cells at Day 5: 88.9% vs 62.5%, p = 0.0456). In the active group, a lower percentage of SARS-CoV-2 positive household contacts (0-10.7%) was reported vs controls (3.2-16.1%) among subjects with Delta variant (p = 0.0413). CONCLUSION: This trial showed the efficacy and safety of seawater nasal wash in COVID-19 and URTIs. TRIAL REGISTRATION: Trial registry ClinicalTrials.gov: NCT04916639. Registration date: 04.06.2021.

The effect of nasal douching by hypertonic 2.3 per cent sea water with algae extracts on the concentration of epidermal growth factor, transforming growth factor-α and interleukin-8 in nasal secretions of patients with nasal polyposis following endoscopic surgical treatment.

OBJECTIVE: To investigate epidermal growth factor, transforming growth factor-α and interleukin-8 production in nasal mucosa irrigated with hypertonic 2.3 per cent solution with algae extracts, in comparison to 0.9 per cent NaCl during the first two weeks after surgery for nasal polyposis, in relation to symptoms and local findings. METHODS: This prospective study included 20 nasal polyposis patients postoperatively irrigated with hypertonic solution and 20 nasal polyposis patients postoperatively irrigated with isotonic solution. We evaluated nasal symptom score, endoscopic score and mediator levels in nasal secretions before and after irrigation. RESULTS: Following treatment, nasal symptom score and endoscopic score were significantly lower in the hypertonic solution group (p = 0.023; p < 0.001, respectively). The increase in the epidermal growth factor and the decrease in the transforming growth factor-α and interleukin-8 concentration were higher in the hypertonic group (p < 0.001 for all mediators). CONCLUSION: Irrigation with a hypertonic solution was found to be more effective than an isotonic solution in nasal mucosa reparation.

Nasal lavage microbiome, but not nasal swab microbiome, correlates with sinonasal inflammation in children with cystic fibrosis.

BACKGROUND: Cystic fibrosis (CF) is characterized by highly viscous mucus obstructing the lower and upper airways, chronic neutrophil inflammation and infection resulting not only in lung destruction but also in paranasal sinus involvement. The pathogenesis of CF-associated chronic rhinosinusitis (CRS) is still not well understood, and it remains unclear how the microbiome in the upper airways (UAW) influences paranasal sinus inflammation. METHODS: In a cross-sectional study in pediatric patients with CF under stable disease conditions, we examined the microbiome in relation to inflammation by comparing nasal swabs (NS) and nasal lavage (NL) as two UAW sampling methods. The microbiota structure of both NS and NL was determined by 16S rRNA gene amplicon sequencing. In addition, pro-inflammatory cytokines (IL-1ß, IL-6, IL-8, TNF-α) and proteases (SLPI, TIMP-1, NE/A1-AT complex) as well as neutrophil elastase activity were measured in NL. RESULTS: Simultaneous NS and NL samples were collected from 36 patients with CF (age range: 7 - 19 years). The microbiome of NS samples was shown to be significantly lower in α-diversity and evenness compared to NL samples. NS samples were particularly found to be colonized with Staphylococcus species. NL microbiome was shown to correlate much better with the sinonasal inflammation status than NS microbiome. Especially the detection of Moraxella in NL was associated with increased inflammatory response. CONCLUSION: Our results show that the NL microbiome reflects sinonasal inflammation better than NS and support NL as a promising tool for simultaneous assessment of the UAW microbiome and inflammation in children with CF.

A large-volume low-pressure nasal irrigation delivers drug into the nasal cavity? An in vivo study.

The nasal administration route emerged as an interesting route in systemic and brain drug delivery, and different modalities of nasal delivery are available. The nasal irrigation is one of them, but there is a lack of studies investigating the distribution of a large-volume irrigation. The main aim of this study was to assess the deposition of radiolabeled saline in the nasal cavities and paranasal sinuses following nasal irrigation by imaging. Five healthy males volunteered to perform large-volume low-pressure nasal irrigation, with a douching device containing 50 mL of radiolabeled isotonic saline. Participants underwent a scintigraphy immediately after. Both the nasal cavities and maxillary sinuses were systematically reached by the solution during nasal irrigation. The sinuses set in a lower position during nasal irrigation showed a tendency to be more irrigated than the sinuses set in a higher position (7.67% vs 22.72%; p = 0.086). Moreover, substantial inter- and intraindividual heterogeneity regarding solution deposition was observed. Large-volume low-pressure nasal irrigation is a good modality to reach the maxillary sinuses as well as the nasal cavities. In order to ensure adequate reaching of both nasal cavities and paranasal sinuses, nasal irrigation should be performed bilaterally.

Nasal Irrigation Delivery in Three Post-FESS Models From a Squeeze-bottle Using CFD.

PURPOSE: Nasal saline irrigation is highly recommended in patients following functional endoscopic sinus surgery (FESS) to aid the postoperative recovery. Post-FESS patients have significantly altered anatomy leading to markedly different flow dynamics from those found in pre-op or non-diseased airways, resulting in unknown flow dynamics. METHODS: This work investigated how the liquid stream disperses through altered nasal cavities following surgery using Computational Fluid Dynamics (CFD). A realistic squeeze profile was determined from physical experiments with a 27-year-old male using a squeeze bottle with load sensors. The administration technique involved a head tilt of 45-degrees forward to represent a head position over a sink. After the irrigation event that lasted 4.5 s, the simulation continued for an additional 1.5 s, with the head orientation returning to an upright position. RESULTS: The results demonstrated that a large maxillary sinus ostium on the right side allows saline penetration into this sinus. The increased volume of saline entering the maxillary sinus limits the saline volume available to the rest of the sinonasal cavity and reduces the surface coverage of the other paranasal sinuses. The average wall shear stress was higher on the right side than on the other side for two patients. The results also revealed that head position alters the sinuses' saline residual, especially the frontal sinuses. CONCLUSION: While greater access to sinuses is achieved through FESS surgery, patients without a nasal septum limits posterior sinus penetration due to the liquid crossing over to the contralateral cavity and exiting the nasal cavity early.

Development of an apparatus and procedure for evaluating the efficiency of nasal irrigation.

BACKGROUND: Although different methods of nasal irrigation have been utilized, irrigation efficiency in nasal cavities has not been well assessed. The objective of this study was to develop an apparatus and procedure for evaluating the irrigation efficiency and to explore the optimal head position during irrigation. METHODS: Casts of the left sinonasal cavity from a healthy volunteer were made from high-resolution-computed tomography data using 3D printing with composite materials. An adjustable apparatus that allowed cast fixation at the different head positions was built. The yogurt was used to simulate mucus. The cast with 5 ml yogurt filled around the superior, middle, and inferior turbinate was fixed in six head positions including head tilt 10°, 45°, and 60° forward with or without leaning 30° to the right. The cast was irrigated with 120 ml, 175 ml, and 240 ml dyed water and was video recorded. The irrigation efficiency was calculated based on the weight difference of the cast before and after the irrigation. RESULTS: Most residual yogurt was located around the superior meatus after the irrigation under different volumes and head positions. The irrigation efficiency of the rinse bottle or the pulsatile device was volume dependent, with the highest irrigation efficiency under 240 ml water. When the left sinonasal cavity was irrigated, the head position of tilt 45° forward with leaning 30° to the right was the optimal head position for these two devices when compared to other positions. The pulsatile device with 240 ml water performed better than the rinse bottle with 240 ml water regarding the irrigation efficiency under the optimal head position (0.8700 ± 0.0138 vs 0.7536 ± 0.0099, p = 0.003). CONCLUSIONS: The developed apparatus provided a potential method for evaluating the irrigation efficiency. The head position of tilt 45° forward with leaning 30° was suitable for patients to perform the nasal irrigation.

Effect of hypochlorous acid nasal spray as an adjuvant therapy after functional endoscopic sinus surgery.

OBJECTIVES: To evaluate the efficacy of hypochlorous acid (HOCl) nasal spray as an adjuvant therapy after functional endoscopic sinus surgery (FESS). MATERIAL AND METHODS: Patients with chronic rhinosinusitis who had received FESS for treatment were recruited and assigned to one of two groups at random at one month post-surgery. In the HOCl group, patients received 0.02% HOCl nasal spray three times a day for two months. In the control group, normal saline (NS) nasal irrigation was given. Before FESS and before and after nasal spray or irrigation, patients completed the Taiwanese version of the 22-item Sino-Nasal Outcome Test (TWSNOT-22). In addition, patients received endoscopic examination, acoustic rhinometry, smell test, saccharine transit test, and bacterial cultures obtained from their middle meatus. RESULTS: Seventy-eight patients completed the study. Among them, 41 received HOCl nasal spray, and 37 received NS irrigation. Endoscopic score significantly decreased after 2-month HOCl nasal spray (p = 0.036). TWSNOT-22 score also decreased, although insignificantly (p = 0.285). In contrast, TWSNOT-22 score significantly decreased after NS nasal irrigation (p = 0.017), but endoscopic score did not significantly decrease (p = 0.142). CONCLUSIONS: Our results showed that HOCl nasal spray had a similar effect to that of NS nasal irrigation in post-FESS care. It can be an alternative of NS nasal irrigation for its convenient application.

Efficacy of Povidone-Iodine Nasal Irrigation Solution After Sinonasal Surgery: A Randomized Controlled Study.

OBJECTIVES/HYPOTHESIS: To evaluate the efficacy of postoperative nasal irrigation with povidone-iodine (PVP-I) solution in patients undergoing sinonasal surgery. STUDY DESIGN: Single-blind, randomized controlled study. METHODS: This is a prospective, single-blind, randomized controlled study. Patients with chronic rhinosinusitis (CRS) and hypertrophic inferior turbinates who underwent endoscopic sinus surgery (ESS) and inferior turbinate reduction were enrolled in the study. Patients were evaluated using the Taiwanese version of the 22-item Sino-Nasal Outcome Test (TWSNOT-22), rhinomanometry, endoscopic examination, and bacterial cultures. One week after the operation, patients were randomly assigned to either a 0.1% PVP-I nasal irrigation group or a control (normal saline) irrigation group. We then compared the two groups' results to illustrate the effects of nasal irrigation with PVP-I solution following sinonasal surgery. RESULTS: Of the 55 patients that completed the study, 27 patients were in the PVP-I group and 28 were in the control group. In both groups, the TWSNOT-22 scores, Lund-Kennedy endoscopic scores, and total nasal resistance (TNR) all revealed significant improvements at 3 months postoperatively compared with preoperative measurements (all, P < .05). However, there were no significant differences between the two groups in TWSNOT-22, endoscopic, or TNR scores 3 months after the operation (all, P > .05). CONCLUSIONS: A dilute 0.1% PVP-I nasal irrigation as a postoperative care modality after sinonasal surgery did not provide additional benefit compared with normal saline irrigation. LEVEL OF EVIDENCE: 2 Laryngoscope, 132:1148-1152, 2022.

Effect of Postoperative Specific Immunotherapy Combined with Nasal Irrigation on Chronic Rhinosinusitis with Allergic Rhinitis.

Patients with chronic rhinosinusitis (CRS) and allergic rhinitis (AR) (CRSwAR) have a more severe condition with a higher rate of recurrence after endoscopic sinus surgery (ESS). This study aimed to explore the effect of specific subcutaneous immunotherapy (SCIT) and nasal irrigation on CRSwAR after ESS. Sixty-four patients who were diagnosed as CRSwAR and received ESS were enrolled and divided into groups A, B, and C to receive different postoperative treatment strategies (conventional medication, medication with nasal irrigation, and medication with nasal irrigation and SCIT), and their prognosis was evaluated by scoring, electron microscopy, and inflammatory factors. One year after ESS, the recurrence rate of group C was significantly reduced; and the scoring from baseline was significantly different among the three groups, which of group C were the best. The epithelium arrangement, cilia morphology, and inflammation of nasal mucosa in each group were better than those in the preoperative state; and those in group C were the best. After one year, the expression levels of eosinophil cationic protein (ECP), interleukin (IL)-8, and IL-17 in group B were lower than those of group A; and the expression levels of ECP, IL-8, IL-25, IL-33, IL-17 in group C were lower than those in group A. SCIT combined with nasal irrigation can improve the patients' symptoms and quality of life, promote the epithelialization of the mucosa in the surgical cavity, regulate the local immune response of the nasal cavity; thus improve the prognosis of patients with ESS after 1 year.

Ivacaftor Reduces Inflammatory Mediators in Upper Airway Lining Fluid From Cystic Fibrosis Patients With a G551D Mutation: Serial Non-Invasive Home-Based Collection of Upper Airway Lining Fluid.

In cystic fibrosis (CF) therapy, the recent approval of CF-transmembrane conductance regulator (CFTR) channel modulators is considered to be the major breakthrough. However, the current first-line approach based mainly on pulmonary function to measure effects of the novel therapy, tested by forced expiratory volumes in one second (FEV1), provides restricted sensitivity to detect early structural damages. Accordingly, there is a need for new sensitive surrogate parameters. Most interestingly, these should quantify inflammation that precedes a decline of pulmonary function. We present a novel method assessing inflammatory markers in the upper airways' epithelial lining fluid (ELF) obtained by nasal lavage (NL). In contrast to broncho-alveolar lavage, ELF sampling by NL is an attractive method due to its limited invasiveness which allows repeated analyses, even performed in a home-based setting. In a longitudinal cohort study (ClinicalTrials.gov, Identifier: NCT02311140), we assessed changes of inflammatory mediators in 259 serially obtained nasal lavages taken up to every second day before and during therapy with ivacaftor from ten CF patients carrying a G551D mutation. Patients were trained to sample NL-fluid at home, to immediately freeze and transfer chilled secretions to centers. Neutrophil Elastase, Interleukins IL-1ß, IL-6 and IL-8 in NL were quantified. During 8-12 weeks of ivacaftor-treatment, median values of IL-1ß and IL-6 significantly declined 2.29-fold (2.97→1.30 pg/mL), and 1.13-fold (6.48→5.72 pg/mL), respectively. In parallel, sweat tests and pulmonary function improved considerably. This is the first study assessing changes of airway inflammation on a day-to-day basis in CF patients receiving a newly administered CFTR-modulator therapy. It proves a decline of airway inflammation during ivacaftor-therapy.

Zero-Degree Endoscopic Visualization of the Frontal Sinus Predicts Improved Topical Irrigation Delivery.

OBJECTIVE: Management of chronic frontal rhinosinusitis is challenging with high rates of treatment failure, exacerbated by limitations of topical irrigation delivery. We hypothesize that intraoperative zero-degree visualization of the frontal sinus predicts improved postoperative irrigation penetration. Extending a Draf IIa frontal sinusotomy with a limited resection of the middle turbinate axilla-agger nasi complex can allow zero-degree endoscopic visualization of the frontal sinus. This study investigates the change in frontal sinus irrigation delivery after standard Draf IIa frontal sinusotomy versus further resection to achieve zero-degree visualization. STUDY DESIGN: This is a prospective cohort study conducted in a surgical skills laboratory. METHODS: The extent of irrigant penetration into the frontal sinuses was evaluated in 10 cadaveric frontal sinuses following Draf IIa sinusotomy using a standardized trephine visualization model. Irrigant penetration was assessed by three blinded reviewers using the following scale: 0 = irrigation restricted to nasal cavity; 1 = irrigation reaches frontal recess; 2 = irrigation reaches frontal sinus proper; 3 = irrigation fills entire frontal sinus. These results were compared to irrigation after achieving zero-degree endoscopic visualization by performing limited resection of the middle turbinate axilla-agger nasi complex. RESULTS: Irrigant penetration following standard Draf IIa frontal sinusotomy improved after the axilla-agger nasi complex was resected to achieve zero-degree endoscopic visualization (median score 2 [interquartile range: 1-2] vs. 3 [interquartile range: 2-3], P < .01). CONCLUSION: This study demonstrates improved penetration of frontal sinus irrigation following limited resection of the middle turbinate axilla-agger nasi complex to achieve zero-degree endoscopic visualization of the frontal sinus as compared to standard Draf IIa frontal sinusotomy. LEVEL OF EVIDENCE: N/A Laryngoscope, 131:250-254, 2021.

Vivendo bem com DPOC: orientações para o autocuidado / Vivendo bem com DPOC: orientações para o autocuidado

Produto do projeto: Impacto da coordenação e acompanhamento do cuidado por telemonitoramento na qualidade da assistência prestada aos usuários do SUS portadores de doenças crônicas, egressos de internação hospitalar em Belo Horizonte, MG, Brasil.

Effects of oral desloratadine citrate disodium combined with physiological seawater nasal irrigation on IgE levels, IL-4, IL-6, IL-13 and IFN-γ expression and treatment of intermittent allergic rhinitis.

This experiment was performed to explore the effect of oral desloratadine citrate disodium combined with physiological seawater nasal irrigation in the treatment of intermittent allergic rhinitis and its effect on serum inflammatory factors and peripheral blood Th1 and Th2. For this purpose, 100 patients of intermittent allergic rhinitis admitted to our hospital from January 2018 to January 2020. Randomly divided into a control group (n=50) and an observation group (n=50). The control group was given oral desloratadine citrate disodium. The observation group was given physiological seawater nasal irrigation based on the control group. Both groups were treated for one month. Compare the effect of treatment, symptom and sign scores pre and posttreatment, serum immunoglobulin E (IgE) levels, serum interleukin 4 (IL-4), IL-6, IL-13 and interferon-gamma (IFN-γ) levels, peripheral blood helper T cells 1 (Th1) and Th2 and the recurrence rate of patients after 1 year between two groups. Results showed that after one month of continuous treatment, the total effective rate of the observation group was significantly higher than that of the control group (P <0.05). The symptoms and signs scores and serum IgE levels of the two groups pretreatment (before treatment) were not significantly different (P > 0.05). The symptoms and signs scores and serum IgE levels of the two groups decreased significantly posttreatment (after treatment) (P <0.05), and the observation group was significantly lower than the control group (P <0.05). Pretreatment, the levels of serum inflammatory factors (IL-4, IL-6, IL-13, and IFN-γ) and the ratio of peripheral blood Th1 and Th2 to CD4+T cells were not significantly different (P> 0.05). After one month of continuous treatment, the levels of serum IL-4, IL-6, IL-13, and the ratio of peripheral blood CD4+IL-4+/CD4+ in the observation group and the control group were significantly reduced and the ratio of CD4+IFN-γ+/CD4+ was significantly increased (P <0.05). Compared with the control group, those changes were more obvious in the observation group (P <0.05). The one-year recurrence rate of the observation group was 4% (2/50), which was significantly lower than that of the control group, which was 20% (10/50). There was a statistical difference between the two groups (P <0.05). It was concluded that oral desloratadine citrate disodium combined with physiological seawater nasal irrigation can effectively improve the symptoms and signs of intermittent allergic rhinitis and reduce the recurrence rate. This may be related to balancing T cell responses, promoting systemic Th1 responses and inhibiting Th2 responses, and down-regulating inflammatory response.

A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: 1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients. 2- To determine the salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL- 17 among COVID-19 patients subjected to 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline or Neem extract (Azardirachta indica) based gargles. TRIAL DESIGN: This will be a parallel group, quadruple blind-randomised controlled pilot trial with an add on laboratory based study. PARTICIPANTS: A non-probability, purposive sampling technique will be followed to identify participants for this study. The clinical trial will be carried out at the Aga Khan University Hospital (AKUH), Karachi, Pakistan. The viral PCR tests will be done at main AKUH clinical laboratories whereas the immunological tests (cytokine analysis) will be done at the Juma research laboratory of AKUH. The inclusion criteria are laboratory-confirmed COVID-19 positive patients, male or female, in the age range of 18-65 years, with mild to moderate disease, already admitted to the AKUH. Subjects with low Glasgow coma score, with a history of radiotherapy or chemotherapy, who are more than 7 days past the onset of COVID- 19 symptoms, or intubated or edentulous patients will be excluded. Patients who are being treated with any form of oral or parenteral antiviral therapy will be excluded, as well as patients with known pre-existing chronic mucosal lesions such as lichen planus. INTERVENTION AND COMPARATOR: Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene® by Aviro Health Inc./ Pyodine® by Brooks Pharma Inc.) for 20-30 seconds, thrice daily for 6 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (HP® by Karachi Chemicals Products Inc./ ActiveOxy® by Boumatic Inc.) for 20-30 seconds, thrice daily for 6 days. Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated by Karachi University (chemistry department laboratories) for 20-30 seconds, thrice daily for 6 days. Group D (n=10) patients will use 2% hypertonic saline (Plabottle® by Otsuka Inc.) gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days. For nasal lavage, a special douche syringe will be provided to each participant. Its use will be thoroughly explained by the data collection officer. After each use, the patient is asked not to eat, drink, or rinse their mouth for the next 30 minutes. MAIN OUTCOMES: The primary outcome is the reduction in the intra-oral viral load confirmed with real time quantitative PCR. RANDOMISATION: The assignment to the study group/ allocation will be done using the sealed envelope method under the supervision of Clinical Trial Unit (CTU) of Aga Khan University, Karachi, Pakistan. The patients will be randomised to their respective study group (1:1:1:1:1 allocation ratio) immediately after the eligibility assessment and consent administration is done. BLINDING (MASKING): The study will be quadruple-blinded. Patients, intervention provider, outcome assessor and the data collection officer will be blinded. The groups will be labelled as A, B, C, D or E. The codes of the intervention will be kept in lock & key at the CTU and will only be revealed at the end of study or if the study is terminated prematurely. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. The present study will serve as a pilot trial. We intend to study 50 patients in five study groups with 10 patients in each study group. For details, please refer to Fig. 1 for details. TRIAL STATUS: Protocol version is 7.0, approved by the department and institutional ethics committees and clinical trial unit of the university hospital. Recruitment is planned to start as soon as the funding is sanctioned. The total duration of the study is expected to be 6 months i.e. August 2020-January 2021. TRIAL REGISTRATION: This study protocol was registered at www.clinicaltrials.gov on 10 April 2020 NCT04341688 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). Fig. 1 Flow diagram of study-participants' timeline.

Effectiveness of micronized nasal irrigations with hyaluronic acid/isotonic saline solution in non-polipoid chronic rhinosinusitis: A prospective, randomized, double-blind, controlled study.

BACKGROUND: Sodium hyaluronate has been proposed as a treatment for improving the symptoms of chronic rhinosinusitis. The present study evaluated the effect of the intranasal administration of hyaluronic acid in a group of patients affected by chronic rhinosinusitis without nasal polyps (CRSsNP). MATERIALS AND METHODS: Thirty subjects aged 18-65 years affected by CRSsNP were enrolled. The subjects were randomly administered hyaluronic acid or isotonic saline solution by nasal nebulizer twice per day for 30 days. They were evaluated before (T0) and after the treatment (T1) with Sino-Nasal Outcome Test-22, visual analogue scale for rhinorrhea, nasal obstruction, facial pain and hyposmia/hypogeusia, nasal endoscopy, active anterior rhinomanometry, peak nasal inspiratory flow and nasal cytology. RESULTS: Comparing the study and the control group, at T1 no significant differences were observed in both objective and subjective parameters. Being included in the study group rather than in the control group did not have a significant effect on the variation of the considered parameters between T0 and T1. Considering the effects of the micronized douches independently from the type of solution used (either hyaluronic acid or isotonic saline solution), although no difference emerged between study and control group for any of the objective parameters, there was an improvement of Sino-Nasal Outcome Test-22 scores (p = .0005), visual analogue scale for nasal obstruction (p = .0006) and for hyposmia/hypogeusia (p = .04). CONCLUSIONS: The treatment with micronized nasal douches can improve the sino-nasal symptoms of CRSsNP, in particular nasal obstruction and olfactory ability. No advantage of the use of hyaluronic acid over isotonic saline solution emerged.

Latest developments on topical therapies in chronic rhinosinusitis.

PURPOSE OF REVIEW: Topical therapies play an important role in the management of chronic rhinosinusitis (CRS). A detailed literature review was undertaken to appraise recent evidence surrounding current topical therapies and novel treatments used in the setting of recalcitrant CRS. RECENT FINDINGS: Effective sinus surgery aids in the delivery of topical therapies. Budesonide nasal rinses delivered by saline irrigation offer clinical and symptomatic improvements pre and postoperatively with a well-proven safety profile. Topical steroids may additionally offer direct antibacterial effects as per in-vitro testing. Topical antibiotics are not recommended in routine practice; however, they may be of benefit for short-term eradication therapy. Novel treatments are under keen investigation and include bacteriophage, colloidal silver and manuka honey. The evidence base for these treatments is not robust enough to recommend their routine use at present. SUMMARY: Topical steroids delivered in conjunction with saline nasal irrigation offer the best combination of treatments in CRS and should be considered a standard of care. Wide surgical access and aggressive surgical debridement of polyposis facilitates the delivery of steroid irrigations to sinonasal mucosa and is associated with improved long-term outcomes following endoscopic sinus surgery. The use of novel treatments remains within the research setting alone.

Effects of nasal lavage with and without mupirocin after endoscopic endonasal skull base surgery: a randomised, controlled study.

BACKGROUND: Nasal lavage with mupirocin has the potential to reduce sinonasal morbidity in endoscopic endonasal approaches for skull base surgery. OBJECTIVE: To evaluate the effects of nasal lavage with and without mupirocin after endoscopic endonasal skull base surgery. METHODS: A pilot randomised, controlled trial was conducted on 20 adult patients who had undergone endoscopic endonasal approaches for skull base lesions. These patients were randomly assigned to cohorts using nasal lavages with mupirocin or without mupirocin. Patients were assessed in the out-patient clinic, one week and one month after surgery, using the 22-item Sino-Nasal Outcome Test questionnaire and nasal endoscopy. RESULTS: Patients in the mupirocin nasal lavage group had lower nasal endoscopy scores post-operatively, and a statistically significant larger difference in nasal endoscopy scores at one month compared to one week. The mupirocin nasal lavage group also showed better Sino-Nasal Outcome Test scores at one month compared to the group without mupirocin. CONCLUSION: Nasal lavage with mupirocin seems to yield better outcomes regarding patients' symptoms and endoscopic findings.