The Prognostic Value of Olfactory Dysfunction in Patients with COVID-19: The COVIDORA Study.

BACKGROUND: Among all studies describing COVID-19 clinical features during the first wave of the pandemic, only a few retrospective studies have assessed the correlation between olfac-tory dysfunction (OD) and the evolution of disease severity. The main aim was to assess whether OD is a predictive factor of COVID-19 severity based on the patient's medical management (outpa-tient care, standard hospital admission, and ICU admission). METHODS: A national, prospective, mul-ticenter cohort study was conducted in 20 public hospitals and a public center for COVID-19 screen-ing. During the first wave of the pandemic, from 6 April to 11 May 2020, all patients tested positive for COVID-19 confirmed by RT-PCR underwent two follow-up ENT consultations within 10 days of symptom onset. The main outcome measures were the evolution of medical management (out-patient care, standard hospital admission, and ICU admission) at diagnosis and along the clinical course of COVID-19 disease. RESULTS: Among 481 patients included, the prevalence of OD was 60.7%, and it affected mostly female patients (74.3%) under 65 years old (92.5%), with fewer comor-bidities than patients with normal olfactory function. Here, 99.3% (290/292) of patients with OD presented with non-severe COVID-19 disease. Patients reporting OD were significantly less hospi-talized than the ones managed as outpatients, in either a standard medical unit or an ICU. Conclu-sions: As regards the clinical course of COVID-19 disease, OD could predict a decreased risk of hospitalization during the first wave of the pandemic.

Efficacy of local budesonide therapy in the management of persistent hyposmia in COVID-19 patients without signs of severity: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: To assess the efficacy of local intranasal treatment with budesonide (nasal irrigation), in addition to olfactory rehabilitation, in the management of loss of smell in COVID-19 patients without signs of severity and with persistent hyposmia 30 days after the onset of symptoms. To search for an association between the presence of an obstruction on MRI and the severity of olfactory loss, at inclusion and after 30 days of treatment. TRIAL DESIGN: Two center, open-label, 2-arm (1:1 ratio) parallel group randomized controlled superiority trial. PARTICIPANTS: Inclusion criteria - Patient over 18 years of age; - Patient with a suspected SARS-CoV-2 infection, whether or not confirmed by PCR, or close contact with a PCR-confirmed case, typical chest CT scan (unsystematic frosted glass patches with predominantly sub-pleural appearance, and at a later stage, alveolar condensation without excavation or nodules or masses) or positive serology ; - Patient with isolated sudden onset hyposmia persisting 30 days after the onset of symptoms of CoV-2 SARS infection; - Affiliate or beneficiary of a social security scheme; - Written consent to participate in the study. Non-inclusion criteria - Known hypersensitivity to budesonide or any of the excipients; - Hemostasis disorder or epistaxis; - Oral-nasal and ophthalmic herpes virus infection; - Long-term corticosteroid treatment; - Treatment with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors); - Severe forms of SARS-CoV-2 with respiratory or other signs; - Hyposmia persisting for more than 90 days after the onset of symptoms - Other causes of hyposmia found on interrogation or MRI; - Patient benefiting from a legal protection measure; - Pregnant or breastfeeding women. The participants will be recruited from: Hôpital Fondation Adolphe de Rothschild and Hôpital Lariboisière in Paris, France INTERVENTION AND COMPARATOR: Intervention: Experimental group: Nasal irrigation with budesonide and physiological saline (Budesonide 1mg/2mL diluted in 250mL of physiological saline 9°/00): 3 syringes of 20mL in each nasal cavity, morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day. CONTROL GROUP: Nasal irrigation with physiological saline 9°/00 only: 3 syringes of 20cc in each nasal cavity, morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day. MAIN OUTCOMES: Percentage of patients with an improvement of more than 2 points on the ODORATEST score after 30 days of treatment. RANDOMISATION: Patients will be randomized (1:1) between the experimental and control groups, using the e-CRF. The randomization list will be stratified by centre. BLINDING (MASKING): Participants and caregivers are aware of the group assignment. People assessing the outcomes are blinded to the group assignment Numbers to be randomised (sample size) 120 patients are planned to be randomized into two groups of 60 patients. TRIAL STATUS: MDL_2020_10. Version number 2, May 22, 2020. Recruitment started on May 22, 2020. The trial will finish recruiting by August 2020. TRIAL REGISTRATION: EUDRACT number: 2020-001667-85; date of trial registration: 15 May 2020 Protocol registered on ClinicalTrial.gov, registration number: NCT04361474 ; date of trial registration: 24 April 2020. 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.

Cartilage Ossiculoplasty from Stapes to Tympanic Membrane in One-Stage Intact Canal Wall Tympanoplasty for Cholesteatoma.

OBJECTIVE: To report hearing results of cartilage interposition ossiculoplasty in one-stage intact canal wall (ICW) tympanoplasty for cholesteatoma with intact stapes. MATERIALS AND METHODS: A retrospective study of pre and postoperative hearing status was conducted at a tertiary referral otologic center in a series of 61 patients having undergone one-stage ICW tympanoplasty for cholesteatoma with intact stapes and cartilage ossiculoplasty during the same procedure. RESULTS: In the preoperative period, the mean air conduction thresholds (AC), air-bone gap (ABG), and speech reception thresholds (SRT) were 35.3, 20.14, and 35.6 dB, respectively. Postoperatively, with a mean follow-up of 29 months, AC, ABG, and SRT were 27.8, 13.34, and 28.8 dB, respectively. Mean hearing gain was 6.8 dB and mean SRT improvement was 6.8 dB. Mean bone conduction thresholds for 1, 2, and 4 kHz remained stable after surgery (17.6 dB preoperatively vs. 18 dB postoperatively). CONCLUSION: Cartilage ossiculoplasty from stapes to tympanic membrane in one-stage ICW tympanoplasty for cholesteatoma is a safe, reliable, easy, and effective procedure, with no additional cost.

Cochlear implantation and congenital deafness: perceptive and lexical results in 2 genetically pediatric identified population.

OBJECTIVE: To evaluate the perceptive and linguistic results in 2 predefined genetic population of children with implants. STUDY DESIGN: Retrospective cohort study. SETTING: Otolaryngology department of a tertiary referral hospital. PATIENTS: Among 336 children with prelingual deafness who underwent implantation in our department between 1997 and 2007, 85 with GJB2 gene-related (Cx) deafness and 30 patients with Waardenburg syndrome (WaardS) were included. Mean age at implantation was 4.7 years (range, 15 mo to 16.5 yr) in the Cx group and 4.8 years (range, 16 mo to 16 yr) in the WaardS group. The mean follow-up period was 6.5 years (range, 19 mo to 12 yr) in the Cx group and 7.1 years (range, 27 mo to 13.5 yr) in the WaardS group. More than 75% of the families in both groups scored 4 and 5 when using the Mary Pat Moeller rating (p > 0.05). A psychoneurological evaluation was performed in one third of the patients in both groups. MAIN OUTCOME MEASURES: Patients underwent linguistic and perceptive evaluations at 12, 24, 36, and 48 months: speech perception with closed-set and open-set words, speech production (Level 1 = vocalizations to Level 5 = complex sentences), and lexical comprehension with EVIP/GaelP (Peabody Picture Vocabulary Test) tests that ranged in 5 levels (-2 SD to +2 SD). RESULTS: Score results for open-set words were 38.5%, 57.5%, 69%, and 75% in the Cx group and 30.5%, 59%, 67.5%, and 78% in the WaardS group (p > 0.05) at 12, 24, 36, and 48 months. The proportion of children in Levels 4 and 5 of speech production was 27%, 42%, 57.5%, and 58% in the Cx group and 23%, 33%, 55%, and 66% in the WaardS group (p > 0.05). Lexical result at Level -2 SD at 1 year was 90% in the Cx group and 85% in the WaardS group and that at 4 years was 70% in the Cx group and 65% in the WaardS group (p > 0.05). CONCLUSION: Perceptive and linguistic evolutions for both populations were of good quality, but lexical evaluation showed residual language difficulties in both groups.

Lengthening temporalis myoplasty versus hypoglossal-facial nerve coaptation in the surgical rehabilitation of facial palsy: evaluation by medical and nonmedical juries and patient-assessed quality of life.

BACKGROUND: To compare the results of 2 techniques of facial rehabilitation, lengthening temporalis myoplasty and 2 types of hypoglossal-facial (XII-VII) coaptation as evaluated by medical and nonmedical teams and patient self-assessment of quality of life (QOL). MATERIALS AND METHODS: Videos of 42 consecutive patients with complete facial palsy who underwent surgery from 1998 to 2005 were reviewed. Facial rehabilitation was by temporalis myoplasty (n = 10) or by XII-VII coaptation (n = 32) either end-to-end (n = 16) or end-to-side with a jump interpositional graft (n = 16). Evaluation was by (i) a medical jury using 4 facial nerve grading systems and 3 other measurements for the face at rest and during voluntary and emotional motions, (ii) a nonmedical jury using the 3 measures described above, and (iii) patient self-assessment of QOL by questionnaires. RESULTS: Whatever the grading systems used, the medical jury rated facial rehabilitation with XII-VII coaptation better than myoplasty. Scores did not differ between the 2 types of coaptation: synkinesis was severe with end-to-end and almost absent with end-to-side coaptation. However, muscle tone was stronger in the end-to-end than end-to-side coaptation. The nonmedical jury considered that XII-VII coaptation, whatever the type, led to better results than myoplasty. Patients in all groups considered their QOL improved by surgery, whatever the format, with no significant differences between the groups. CONCLUSION: This study revealed XII-VII coaptation with better results than myoplasty. End-to-end coaptation should be restricted to patients with a strong emotional expression or those with a long-standing facial palsy because it provides a strong muscle tone but significant synkinesis.

Inlay butterfly cartilage tympanoplasty in children.

OBJECTIVE: To assess the results of inlay butterfly cartilage tympanoplasty in children. STUDY DESIGN: Before-and-after trial; follow-up duration, 26.6 +/- 19.9 months (mean +/- standard deviation). SETTING: Tertiary referral center. PATIENTS: Fifty-nine pediatric cases of tympanic membrane perforation. INTERVENTION: Inlay butterfly cartilage tympanoplasty was performed under general anesthesia according to the technique originally described by Eavey and modified by Lubianca-Neto (i.e., without any associated split-thickness skin graft). MAIN OUTCOME MEASURES: Percentage of perforation closures, surgical complications, preoperative and postoperative puretone hearing thresholds; the results of inlay butterfly cartilage tympanoplasty were compared with those obtained in a retrospective series of 29 underlay fascia temporalis myringoplasties. RESULTS: The 71% "take rate" of inlay butterfly cartilage tympanoplasty was not significantly different from the 83% take rate obtained with underlay fascia temporalis tympanoplasty (p = 0.23, chi test). The anatomic results were improved when the graft diameter was at least 2 mm larger than the size of the perforation (81% take rate) (p = 0.009, chi test). No iatrogenic cholesteatoma was observed. Pure-tone hearing thresholds were improved at 0.5, 1, and 2 kHz, and stable at 4 kHz. Hearing levels were not different from those obtained with underlay fascia temporalis tympanoplasty. CONCLUSION: Inlay butterfly cartilage tympanoplasty is a safe, efficient, time-saving, and easy technique of tympanoplasty in children. Anatomic results may be improved by associating a split-thickness skin graft and/or by trimming a tragal graft much larger than the size of the perforation.