Post-extubation Assessment of Laryngeal Symptoms and Severity

NCT03726086 | Completed

• 2 other identifiers: IRB00151643R01NR017433-01A1
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

larynx; injury; voice; trachea

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (11)

• Oral endotracheal tube size

  At the time of intubation (directly following study enrollment)

• Duration of orotracheal intubation

  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

  Within 72 hours post-extubation

• Perceptual voice characteristics as assessed by GRBAS method

  7 days post-extubation or hospital discharge, whichever occurs first

• Acoustic voice measurement as assessed by voice analysis software

  Within 72 hours post-extubation

Interventions

laryngoscopy DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the intensive care unit (ICU) who are orally intubated with mechanical ventilaton meeting inclusion/exclusion criteria

You may qualify if:

• ≥18 years old
• Required mechanical ventilation via an oral endotracheal tube
• Anticipated intubation ≥8 hours

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related 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.

  PMID: 20934212 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.

  PMID: 22467611 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.

  PMID: 23269131 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.

  PMID: 8470867 BACKGROUND

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

  PMID: 6367543 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.

  PMID: 3718696 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.

  PMID: 30096101 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.

  PMID: 2791687 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.

  PMID: 1736742 BACKGROUND

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

  PMID: 5347141 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.

  PMID: 569990 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.

  PMID: 3766091 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.

  PMID: 17511179 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.

  PMID: 16905292 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.

  PMID: 8633963 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.

  PMID: 25072754 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.

  PMID: 23804513 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.

  PMID: 2589761 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.

  PMID: 7936678 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.

  PMID: 26215724 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.

  PMID: 20237758 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.

  PMID: 23755732 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Laryngeal Diseases; Wounds and Injuries; Tracheal Diseases

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Dale M. Needham, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 31, 2018
• Study Start: February 12, 2019
• Primary Completion: June 10, 2023
• Study Completion: June 10, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)