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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR017433-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The goal of this study is to learn more about voice and airway problems that patients experience during and after the time patients have an oral endotracheal tube in patients' airway to help patients breathe while receiving mechanical ventilation in an intensive care unit (ICU).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laryngoscopy | Diagnostic Test | A flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway. |
| Measure | Description | Time Frame |
|---|---|---|
| Laryngeal injury as assessed by 4-point categorical scale | Characterize injuries to the larynx and surrounding tissues/anatomy after mechanical ventilation is no longer required and the oral endotracheal tube is removed. Injuries will be graded on a 4-point categorical scale ranging from 0 (no injury) to 3 (severe injury). | Within 72 hours post-extubation |
| Laryngeal injury symptom grading by Laryngeal Hypersensitivity Questionnaire (LHQ) | Characterize patient symptoms of laryngeal injury within 48 hours of anticipated extubation. Symptoms will be assessed using a 4-point ordinal scale based on the LHQ, ranging from 1 (all of the time) to 4 (none of the time). | Within 48 hours of anticipated extubation |
| Laryngeal injury symptom grading by LHQ | Characterize patient symptoms of laryngeal injury within 72 hours post-extubation. Symptoms will be assessed using a 4-point ordinal scale based on the LHQ, ranging from 1 (all of the time) to 4 (none of the time). | Within 72 hours post-extubation |
| Laryngeal injury symptom grading by LHQ | Characterize patient symptoms of laryngeal injury at 7 days post-extubation or at discharge whichever comes first. Symptoms will be assessed using a 4-point ordinal scale based on the LHQ, ranging from 1 (all of the time) to 4 (none of the time). | 7 days post-extubation or hospital discharge, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Oral endotracheal tube size | Size of the endotracheal tube | At the time of intubation (directly following study enrollment) |
| Duration of orotracheal intubation | Number of days from placement to extubation of the oral endotracheal tube |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the intensive care unit (ICU) who are orally intubated with mechanical ventilaton meeting inclusion/exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dale M. Needham, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20934212 | Background | Adhikari NK, Fowler RA, Bhagwanjee S, Rubenfeld GD. Critical care and the global burden of critical illness in adults. Lancet. 2010 Oct 16;376(9749):1339-46. doi: 10.1016/S0140-6736(10)60446-1. Epub 2010 Oct 11. | |
| 22467611 | Background | Balas MC, Vasilevskis EE, Burke WJ, Boehm L, Pun BT, Olsen KM, Peitz GJ, Ely EW. Critical care nurses' role in implementing the "ABCDE bundle" into practice. Crit Care Nurse. 2012 Apr;32(2):35-8, 40-7; quiz 48. doi: 10.4037/ccn2012229. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D007818 | Laryngeal Diseases |
| D014947 | Wounds and Injuries |
| D014133 | Tracheal Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007828 | Laryngoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| From date of intubation to date of extubation or placement of a tracheostomy tube, whichever occurs first, assessed up to 14 days |
| Perceptual voice characteristics as assessed by Grade Rough Breathy Asthenic Strained (GRBAS) method | Assessed from standardized voice samples and digital recordings using the grade, rough, breathy, asthenic, and strained (GRBAS) method with a 4-point ordinal scale ranging from 0 (normal) to 3 (severe). | Within 72 hours post-extubation |
| Perceptual voice characteristics as assessed by GRBAS method | Assessed from standardized voice samples and digital recordings using the grade, rough, breathy, asthenic, and strained (GRBAS) method with a 4-point ordinal scale ranging from 0 (normal) to 3 (severe). | 7 days post-extubation or hospital discharge, whichever occurs first |
| Acoustic voice measurement as assessed by voice analysis software | Assessed from standardized voice samples and digital recordings using the Computerized Speech Lab (PENTAX Medical) with voice analysis software (viz., Multi-Dimensional Voice Program (MDVP); Analysis of Dysphonia in Speech and Voice (ADSV)) to quantify voice characteristics across a number of parameters | Within 72 hours post-extubation |
| Acoustic voice measurement as assessed by voice analysis software | Assessed from standardized voice samples and digital recordings using the Computerized Speech Lab (PENTAX Medical) with voice analysis software (viz., Multi-Dimensional Voice Program (MDVP); Analysis of Dysphonia in Speech and Voice (ADSV)) to quantify voice characteristics across a number of parameters. | 7 days post-extubation or hospital discharge, whichever occurs first |
| Patient perception of voice and voice symptoms assessed by the Voice Symptom Scale (VoiSS) | a 30-item questionnaire that uses scaled scores across 3 domains-impairment (15 items), physical symptoms (8 items), and emotional response (7 items). | Within 72 hours post-extubation and at 7 days post-extubation or hospital discharge, whichever occurs first |
| Isometric Hand Grip Strength-Dynamometry | Grip strength provides a measure of distal muscle strength that has important functional application for patients. Grip strength, tested by hand grip dynamometry, will be assessed in each hand using a Jamar Preston hand dynamometer | Within 48 hours of anticipated extubation, within 72 hours post-extubation, and at 7 days post-extubation or hospital discharge, whichever occurs first |
| Peak tongue strength assessed using the Iowa Oral Performance Instrument (IOPI) | Tongue strength, tested using tongue bulb pressure, will be assessed using the Iowa Oral Performance Instrument (IOPI) | Within 48 hours of anticipated extubation, within 72 hours post-extubation, and at 7 days post-extubation or hospital discharge, whichever occurs first |
| Yale Swallow Protocol | A cognitive screen and administration of a cup containing 3 oz. (90 ml) of water handed to the patient for uninterrupted continuous consumption via cup or straw. Interrupted consumption (i.e., stopping, resting), and/or coughing, choking, throat clearing, or a change in vocal quality (i.e., a wet, gurgly quality after consumption is completed) signifies a failed screening. | Within 72 hours post-extubation |
| Function Oral Intake Scale (FOIS) | A 7-point clinical scale to document change in functional oral intake of food and liquid in patients. | Within 90 days of extubation or at ICU discharge, whichever occurs first |
| 23269131 | Background | Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72. |
| 8470867 | Background | Benjamin B. Prolonged intubation injuries of the larynx: endoscopic diagnosis, classification, and treatment. Ann Otol Rhinol Laryngol Suppl. 1993 Apr;160:1-15. doi: 10.1177/00034894931020s401. |
| 6367543 | Background | Bishop MJ, Weymuller EA Jr, Fink BR. Laryngeal effects of prolonged intubation. Anesth Analg. 1984 Mar;63(3):335-42. No abstract available. |
| 3718696 | Background | Brandwein M, Abramson AL, Shikowitz MJ. Bilateral vocal cord paralysis following endotracheal intubation. Arch Otolaryngol Head Neck Surg. 1986 Aug;112(8):877-82. doi: 10.1001/archotol.1986.03780080077018. |
| 30096101 | Background | Brodsky MB, Levy MJ, Jedlanek E, Pandian V, Blackford B, Price C, Cole G, Hillel AT, Best SR, Akst LM. Laryngeal Injury and Upper Airway Symptoms After Oral Endotracheal Intubation With Mechanical Ventilation During Critical Care: A Systematic Review. Crit Care Med. 2018 Dec;46(12):2010-2017. doi: 10.1097/CCM.0000000000003368. |
| 2791687 | Background | Colice GL, Stukel TA, Dain B. Laryngeal complications of prolonged intubation. Chest. 1989 Oct;96(4):877-84. doi: 10.1378/chest.96.4.877. |
| 1736742 | Background | Colice GL. Resolution of laryngeal injury following translaryngeal intubation. Am Rev Respir Dis. 1992 Feb;145(2 Pt 1):361-4. doi: 10.1164/ajrccm/145.2_Pt_1.361. |
| 5347141 | Background | Donnelly WH. Histopathology of endotracheal intubation. An autopsy study of 99 cases. Arch Pathol. 1969 Nov;88(5):511-20. No abstract available. |
| 569990 | Background | Dubick MN, Wright BD. Comparison of laryngeal pathology following long-term oral and nasal endotracheal intubations. Anesth Analg. 1978 Nov-Dec;57(6):663-8. No abstract available. |
| 3766091 | Background | Eckerbom B, Lindholm CE, Alexopoulos C. Airway lesions caused by prolonged intubation with standard and with anatomically shaped tracheal tubes. A post-mortem study. Acta Anaesthesiol Scand. 1986 Jul;30(5):366-73. doi: 10.1111/j.1399-6576.1986.tb02432.x. |
| 17511179 | Background | Hamdan AL, Sabra O, Rameh C, El-Khatib M. Persistant dysphonia following endotracheal intubation. Middle East J Anaesthesiol. 2007 Feb;19(1):5-13. |
| 16905292 | Background | Hamdan AL, Sibai A, Rameh C, Kanazeh G. Short-term effects of endotracheal intubation on voice. J Voice. 2007 Nov;21(6):762-8. doi: 10.1016/j.jvoice.2006.06.003. Epub 2006 Aug 14. |
| 8633963 | Background | Massard G, Rouge C, Dabbagh A, Kessler R, Hentz JG, Roeslin N, Wihlm JM, Morand G. Tracheobronchial lacerations after intubation and tracheostomy. Ann Thorac Surg. 1996 May;61(5):1483-7. doi: 10.1016/0003-4975(96)00083-5. |
| 25072754 | Background | Pandian V, Thompson CB, Feller-Kopman DJ, Mirski MA. Development and validation of a quality-of-life questionnaire for mechanically ventilated ICU patients. Crit Care Med. 2015 Jan;43(1):142-8. doi: 10.1097/CCM.0000000000000552. |
| 23804513 | Background | Sadoughi B, Fried MP, Sulica L, Blitzer A. Hoarseness evaluation: a transatlantic survey of laryngeal experts. Laryngoscope. 2014 Jan;124(1):221-6. doi: 10.1002/lary.24178. Epub 2013 Jun 26. |
| 2589761 | Background | Santos PM, Afrassiabi A, Weymuller EA Jr. Prospective studies evaluating the standard endotracheal tube and a prototype endotracheal tube. Ann Otol Rhinol Laryngol. 1989 Dec;98(12 Pt 1):935-40. doi: 10.1177/000348948909801204. |
| 7936678 | Background | Santos PM, Afrassiabi A, Weymuller EA Jr. Risk factors associated with prolonged intubation and laryngeal injury. Otolaryngol Head Neck Surg. 1994 Oct;111(4):453-9. doi: 10.1177/019459989411100411. |
| 26215724 | Background | Scheel R, Pisegna JM, McNally E, Noordzij JP, Langmore SE. Endoscopic Assessment of Swallowing After Prolonged Intubation in the ICU Setting. Ann Otol Rhinol Laryngol. 2016 Jan;125(1):43-52. doi: 10.1177/0003489415596755. Epub 2015 Jul 26. |
| 20237758 | Background | Tadie JM, Behm E, Lecuyer L, Benhmamed R, Hans S, Brasnu D, Diehl JL, Fagon JY, Guerot E. Post-intubation laryngeal injuries and extubation failure: a fiberoptic endoscopic study. Intensive Care Med. 2010 Jun;36(6):991-8. doi: 10.1007/s00134-010-1847-z. Epub 2010 Mar 18. |
| 23755732 | Background | Tate JA, Sereika S, Divirgilio D, Nilsen M, Demerci J, Campbell G, Happ MB. Symptom communication during critical illness: the impact of age, delirium, and delirium presentation. J Gerontol Nurs. 2013 Aug;39(8):28-38. doi: 10.3928/00989134-20130530-03. Epub 2013 Jun 10. |
| D010038 | Otorhinolaryngologic Diseases |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |