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| ID | Type | Description | Link |
|---|---|---|---|
| 5K24HL089223 | U.S. NIH Grant/Contract | View source | |
| 1R21NR015886-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Boston University | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FEES & Bedside Swallow Evaluation (BSE) | Other | Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FEES | Procedure | A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Aspiration | Aim: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently diagnose aspiration in ARF survivors. Aspiration (PAS score of ≥6) on the FEES with any of the five feedings. This outcome measure will report the percentage of participants experiencing silent and non-silent aspiration, as visualized on the FEES. The FEES is a flexible fiberoptic camera that allows the investigators to visualize the patient swallowing each of the 5 different consistencies of food. | from extubation Day 1 through hospital discharge, expected to be within 28 days |
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Inclusion Criteria:
Subjects will be eligible to participate in the study if they meet all of the following criteria:
Exclusion Criteria:
Subjects will be ineligible to participate in the study if they meet any of the following criteria
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| Name | Affiliation | Role |
|---|---|---|
| Marc Moss, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11956839 | Background | Ekberg O, Hamdy S, Woisard V, Wuttge-Hannig A, Ortega P. Social and psychological burden of dysphagia: its impact on diagnosis and treatment. Dysphagia. 2002 Spring;17(2):139-46. doi: 10.1007/s00455-001-0113-5. | |
| 11228282 | Background | Marik PE. Aspiration pneumonitis and aspiration pneumonia. N Engl J Med. 2001 Mar 1;344(9):665-71. doi: 10.1056/NEJM200103013440908. No abstract available. |
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Overall, 213 patients were included in the final analysis
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FEES & Bedside Swallow Evaluation (BSE) | Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE). FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed. BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FEES & Bedside Swallow Evaluation (BSE) | Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE). FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed. BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing Aspiration | Aim: To develop a BSE-based non-invasive clinical prediction rule (CPR) that will accurately and efficiently diagnose aspiration in ARF survivors. Aspiration (PAS score of ≥6) on the FEES with any of the five feedings. This outcome measure will report the percentage of participants experiencing silent and non-silent aspiration, as visualized on the FEES. The FEES is a flexible fiberoptic camera that allows the investigators to visualize the patient swallowing each of the 5 different consistencies of food. | Overall, 213 patients were included in the final analysis. | Posted | Number | percentage of participants | from extubation Day 1 through hospital discharge, expected to be within 28 days |
|
Through study completion, about 28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FEES & Bedside Swallow Evaluation (BSE) | Subjects will receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), followed by a speech language pathologist (SLP) performing a bedside swallowing evaluation (BSE). FEES: A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed. BSE: Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | other | Non-systematic Assessment | Subject vomited the night of the BSE and FEES |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Higgins | University of Colorado | 7205603037 | carrie.higgins@cuanschutz.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2015 | Apr 20, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005249 | Fees and Charges |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
Not provided
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|
|
| BSE | Procedure | Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test. |
|
|
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Boston University Medical Center | Boston | Massachusetts | United States |
| 16269630 | Background | Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3. |
| 20713754 | Background | Altman KW, Yu GP, Schaefer SD. Consequence of dysphagia in the hospitalized patient: impact on prognosis and hospital resources. Arch Otolaryngol Head Neck Surg. 2010 Aug;136(8):784-9. doi: 10.1001/archoto.2010.129. |
| Background | Report on the ASHA Speech-Language Pathology Health Care Survey American Speech-Language-Hearing Association. 2011 SLP health care survey summary report: Number and type ofresponses. Available from: http://www.asha.org/uploadedFiles/HC11-Summary-Report.pdf. 2011; 1-49. |
| 20202948 | Background | Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823. |
| 11035684 | Background | Behrendt CE. Acute respiratory failure in the United States: incidence and 31-day survival. Chest. 2000 Oct;118(4):1100-5. doi: 10.1378/chest.118.4.1100. |
| 11790214 | Background | Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345. |
| 21958475 | Background | Macht M, Wimbish T, Clark BJ, Benson AB, Burnham EL, Williams A, Moss M. Postextubation dysphagia is persistent and associated with poor outcomes in survivors of critical illness. Crit Care. 2011;15(5):R231. doi: 10.1186/cc10472. Epub 2011 Sep 29. |
| 10984854 | Background | Goldsmith T. Evaluation and treatment of swallowing disorders following endotracheal intubation and tracheostomy. Int Anesthesiol Clin. 2000 Summer;38(3):219-42. doi: 10.1097/00004311-200007000-00013. No abstract available. |
| 18058175 | Background | Suiter DM, Leder SB. Clinical utility of the 3-ounce water swallow test. Dysphagia. 2008 Sep;23(3):244-50. doi: 10.1007/s00455-007-9127-y. Epub 2007 Dec 4. |
| 12897564 | Background | Hiss SG, Postma GN. Fiberoptic endoscopic evaluation of swallowing. Laryngoscope. 2003 Aug;113(8):1386-93. doi: 10.1097/00005537-200308000-00023. |
| 11213241 | Background | Lim SH, Lieu PK, Phua SY, Seshadri R, Venketasubramanian N, Lee SH, Choo PW. Accuracy of bedside clinical methods compared with fiberoptic endoscopic examination of swallowing (FEES) in determining the risk of aspiration in acute stroke patients. Dysphagia. 2001 Winter;16(1):1-6. doi: 10.1007/s004550000038. |
| 10341109 | Background | O'Neil KH, Purdy M, Falk J, Gallo L. The Dysphagia Outcome and Severity Scale. Dysphagia. 1999 Summer;14(3):139-45. doi: 10.1007/PL00009595. |
| 10594257 | Background | Aviv JE, Kaplan ST, Thomson JE, Spitzer J, Diamond B, Close LG. The safety of flexible endoscopic evaluation of swallowing with sensory testing (FEESST): an analysis of 500 consecutive evaluations. Dysphagia. 2000 Winter;15(1):39-44. doi: 10.1007/s004559910008. |
| 12514376 | Background | Cohen MA, Setzen M, Perlman PW, Ditkoff M, Mattucci KF, Guss J. The safety of flexible endoscopic evaluation of swallowing with sensory testing in an outpatient otolaryngology setting. Laryngoscope. 2003 Jan;113(1):21-4. doi: 10.1097/00005537-200301000-00004. |
| 18939710 | Background | Nacci A, Ursino F, La Vela R, Matteucci F, Mallardi V, Fattori B. Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent. Acta Otorhinolaryngol Ital. 2008 Aug;28(4):206-11. |
| Background | Langmore SE, Pelletier C, Nelson. Results of FEES survey on safety of endoscopy for swallowing assessment. Presented at Fourth Annual Meeting of the Dysphagia Research Society, McLean, VA, October 28, 1995. |
| 22006561 | Background | Leder SB, Suiter DM, Warner HL, Acton LM, Siegel MD. Safe initiation of oral diets in hospitalized patients based on passing a 3-ounce (90 cc) water swallow challenge protocol. QJM. 2012 Mar;105(3):257-63. doi: 10.1093/qjmed/hcr193. Epub 2011 Oct 17. |
| Background | Guidelines and procedures for monitoring VAP. 2011. United States Centers for Disease Control and Prevention (CDC) and National Healthcare Safety Network (NHSN). 22 December 2011. http://www.cdc.gov/nhsn/psc_da.html. 2011; 1-12. |
| 2841893 | Background | Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDC definitions for nosocomial infections, 1988. Am J Infect Control. 1988 Jun;16(3):128-40. doi: 10.1016/0196-6553(88)90053-3. |
| 11934711 | Background | Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078. |
| 14625336 | Background | Chastre J, Wolff M, Fagon JY, Chevret S, Thomas F, Wermert D, Clementi E, Gonzalez J, Jusserand D, Asfar P, Perrin D, Fieux F, Aubas S; PneumA Trial Group. Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial. JAMA. 2003 Nov 19;290(19):2588-98. doi: 10.1001/jama.290.19.2588. |
| 15699079 | Background | American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available. |
| 8630626 | Background | Hospital-acquired pneumonia in adults: diagnosis, assessment of severity, initial antimicrobial therapy, and preventive strategies. A consensus statement, American Thoracic Society, November 1995. Am J Respir Crit Care Med. 1996 May;153(5):1711-25. doi: 10.1164/ajrccm.153.5.8630626. No abstract available. |
| 16714767 | Background | National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21. |
| 1593914 | Background | Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. |
| 11448365 | Background | Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, Goepfert H. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001 Jul;127(7):870-6. |
| 8306032 | Background | Bousquet J, Knani J, Dhivert H, Richard A, Chicoye A, Ware JE Jr, Michel FB. Quality of life in asthma. I. Internal consistency and validity of the SF-36 questionnaire. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):371-5. doi: 10.1164/ajrccm.149.2.8306032. |
| 9014540 | Background | Chrispin PS, Scotton H, Rogers J, Lloyd D, Ridley SA. Short Form 36 in the intensive care unit: assessment of acceptability, reliability and validity of the questionnaire. Anaesthesia. 1997 Jan;52(1):15-23. doi: 10.1111/j.1365-2044.1997.015-az014.x. |
| 3558716 | Background | Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. |
| 12421743 | Background | Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138. |
| 8948561 | Background | Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502. |
| 33635374 | Derived | Langmore SE, Krisciunas GP, Warner H, White SD, Dvorkin D, Fink D, McNally E, Scheel R, Higgins C, Levitt JE, McKeehan J, Deane S, Siner JM, Vojnik R, Moss M. Correction to: Abnormalities of Aspiration and Swallowing Function in Survivors of Acute Respiratory Failure. Dysphagia. 2021 Oct;36(5):842-853. doi: 10.1007/s00455-020-10226-8. |
| 33156398 | Derived | Langmore SE, Krisciunas GP, Warner H, White SD, Dvorkin D, Fink D, McNally E, Scheel R, Higgins C, Levitt JE, McKeehan J, Deane S, Siner JM, Vojnik R, Moss M. Abnormalities of Aspiration and Swallowing Function in Survivors of Acute Respiratory Failure. Dysphagia. 2021 Oct;36(5):831-841. doi: 10.1007/s00455-020-10199-8. Epub 2020 Nov 6. |
| 32804785 | Derived | Krisciunas GP, Langmore SE, Gomez-Taborda S, Fink D, Levitt JE, McKeehan J, McNally E, Scheel R, Rubio AC, Siner JM, Vojnik R, Warner H, White SD, Moss M. The Association Between Endotracheal Tube Size and Aspiration (During Flexible Endoscopic Evaluation of Swallowing) in Acute Respiratory Failure Survivors. Crit Care Med. 2020 Nov;48(11):1604-1611. doi: 10.1097/CCM.0000000000004554. |
| 32721404 | Derived | Moss M, White SD, Warner H, Dvorkin D, Fink D, Gomez-Taborda S, Higgins C, Krisciunas GP, Levitt JE, McKeehan J, McNally E, Rubio A, Scheel R, Siner JM, Vojnik R, Langmore SE. Development of an Accurate Bedside Swallowing Evaluation Decision Tree Algorithm for Detecting Aspiration in Acute Respiratory Failure Survivors. Chest. 2020 Nov;158(5):1923-1933. doi: 10.1016/j.chest.2020.07.051. Epub 2020 Jul 25. |
| 28259057 | Derived | Lynch YT, Clark BJ, Macht M, White SD, Taylor H, Wimbish T, Moss M. The accuracy of the bedside swallowing evaluation for detecting aspiration in survivors of acute respiratory failure. J Crit Care. 2017 Jun;39:143-148. doi: 10.1016/j.jcrc.2017.02.013. Epub 2017 Feb 15. |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 248 |
| 0 |
| 248 |
| 3 |
| 248 |
|
| GI bleed | Gastrointestinal disorders | other | Non-systematic Assessment | subject re-intubated same day after GI bleed |
|
| penetration | Gastrointestinal disorders | other | Non-systematic Assessment | stopped study due to penetration combined with vomiting |
|
Not provided
Not provided
Not provided
| D010038 | Otorhinolaryngologic Diseases |