Post-extubation Assessment of Laryngeal Symptoms and Severity

Critical Illness Clinical Trial

— PALSS  

Official title:

Post-extubation Assessment of Laryngeal Symptoms and Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726086
• Other study ID #: IRB00151643
• Secondary ID: R01NR017433-01A1
• Status: Completed
• Start date: February 12, 2019
• Est. completion date: June 10, 2023

Study information

• Verified date: July 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: June 10, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years old

• Required mechanical ventilation via an oral endotracheal tube

• Anticipated intubation =8 hours

Exclusion Criteria:

• Pre-existing dysphonia, dysphagia

• Pre-existing central nervous system, neuromuscular, or connective tissue disease

• Prior tracheotomy and/or tracheotomy placed prior to enrollment

• History of major thoracic surgery (e.g., sternotomy, thoracotomy) prior to the current admission

• Head and/or neck disease

• Head and/or neck surgery other than tonsillectomy

• Known or suspected anatomical abnormalities or pre-intubation trauma of the oral cavity, pharynx, larynx, or esophagus

• Unlikely to be extubated (i.e., expected death)

Related Conditions & MeSH terms

• Complication of Ventilation Therapy
• Critical Illness
• Intubation, Intratracheal
• Mechanical Ventilation Complication

Intervention

Diagnostic Test:
• laryngoscopy
A flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Bishop MJ, Weymuller EA Jr, Fink BR. Laryngeal effects of prolonged intubation. Anesth Analg. 1984 Mar;63(3):335-42. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Donnelly WH. Histopathology of endotracheal intubation. An autopsy study of 99 cases. Arch Pathol. 1969 Nov;88(5):511-20. No abstract available. — View Citation

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. — View Citation

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. — View Citation

Hamdan AL, Sabra O, Rameh C, El-Khatib M. Persistant dysphonia following endotracheal intubation. Middle East J Anaesthesiol. 2007 Feb;19(1):5-13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Oral endotracheal tube size	Size of the endotracheal tube	At the time of intubation (directly following study enrollment)
Secondary	Duration of orotracheal intubation	Number of days from placement to extubation of the oral endotracheal tube	From date of intubation to date of extubation or placement of a tracheostomy tube, whichever occurs first, assessed up to 14 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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