Intubation, IntratrachealPALSSNCT03726086
Post-extubation Assessment of Laryngeal Symptoms and Severity
An observational study of Intubation, Intratracheal and Critical Illness, run by Johns Hopkins University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Intratracheal, Critical Illness, Mechanical Ventilation Complication
- What is being tested?
- laryngoscopy
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 10 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the intensive care unit (ICU) who are orally intubated with mechanical ventilaton meeting inclusion/exclusion criteria
Who may be able to join
- ≥18 years old
- Required mechanical ventilation via an oral endotracheal tube
- Anticipated intubation ≥8 hours
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- laryngoscopy
- Keywords
- larynx, injury, voice, trachea
- Medical subject headings
- Critical Illness, Laryngeal Diseases, Wounds and Injuries, Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngoscopyDiagnostic test
A flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 7 days post-extubation or hospital discharge, whichever occurs first
Secondary outcomes (11)
Oral endotracheal tube size
Size of the endotracheal tube
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Within 90 days of extubation or at ICU discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start12 Feb 2019
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Dale M. Needham, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726086
- Sponsor's protocol ID
- IRB00151643
- Other IDs
- R01NR017433-01A1
- Acronym
- PALSS
- Status last verified
- Jul 2023
- First submitted
- 26 Oct 2018
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20934212Balas 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.
PubMed 22467611Barr 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.
PubMed 23269131Benjamin 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.
PubMed 8470867Bishop MJ, Weymuller EA Jr, Fink BR. Laryngeal effects of prolonged intubation. Anesth Analg. 1984 Mar;63(3):335-42. No abstract available.
PubMed 6367543Brandwein 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.
PubMed 3718696Brodsky 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.
PubMed 30096101Colice GL, Stukel TA, Dain B. Laryngeal complications of prolonged intubation. Chest. 1989 Oct;96(4):877-84. doi: 10.1378/chest.96.4.877.
PubMed 2791687Colice 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.
PubMed 1736742Donnelly WH. Histopathology of endotracheal intubation. An autopsy study of 99 cases. Arch Pathol. 1969 Nov;88(5):511-20. No abstract available.
PubMed 5347141Dubick 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.
PubMed 569990Eckerbom 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.
PubMed 3766091Hamdan AL, Sabra O, Rameh C, El-Khatib M. Persistant dysphonia following endotracheal intubation. Middle East J Anaesthesiol. 2007 Feb;19(1):5-13.
PubMed 17511179Hamdan 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.
PubMed 16905292Massard 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.
PubMed 8633963
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-extubation Assessment of Laryngeal Symptoms and Severity
- ClinicalTrials.gov ID
- NCT03726086
- Acronym / sponsor ID
- PALSS / IRB00151643
- Conditions
- Intubation, Intratracheal, Critical Illness, Mechanical Ventilation Complication, Complication of Ventilation Therapy
- Keywords
- larynx, injury, voice, trachea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care unit (ICU) who are orally intubated with mechanical ventilaton meeting inclusion/exclusion criteria
Key inclusion criteria (3 listed)
- ≥18 years old
- Required mechanical ventilation via an oral endotracheal tube
- Anticipated intubation ≥8 hours
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laryngoscopyA flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway. | Diagnostic test | – |
Primary outcome
Laryngeal injury as assessed by 4-point categorical scale
Time frame: Within 72 hours post-extubation
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).
Laryngeal injury symptom grading by Laryngeal Hypersensitivity Questionnaire (LHQ)
Time frame: Within 48 hours of anticipated extubation
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).
Laryngeal injury symptom grading by LHQ
Time frame: Within 72 hours post-extubation
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).
Laryngeal injury symptom grading by LHQ
Time frame: 7 days post-extubation or hospital discharge, whichever occurs first
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).
11 secondary outcomes
Oral endotracheal tube size
Time frame: At the time of intubation (directly following study enrollment)
Duration of orotracheal intubation
Time frame: 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
Time frame: Within 72 hours post-extubation
Perceptual voice characteristics as assessed by GRBAS method
Time frame: 7 days post-extubation or hospital discharge, whichever occurs first
Acoustic voice measurement as assessed by voice analysis software
Time frame: Within 72 hours post-extubation
Acoustic voice measurement as assessed by voice analysis software
Time frame: 7 days post-extubation or hospital discharge, whichever occurs first
Patient perception of voice and voice symptoms assessed by the Voice Symptom Scale (VoiSS)
Time frame: Within 72 hours post-extubation and at 7 days post-extubation or hospital discharge, whichever occurs first
Isometric Hand Grip Strength-Dynamometry
Time frame: 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)
Time frame: 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
Time frame: Within 72 hours post-extubation
Function Oral Intake Scale (FOIS)
Time frame: Within 90 days of extubation or at ICU discharge, whichever occurs first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 20934212Adhikari 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.
- Background: PubMed 22467611Balas 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.
- Background: PubMed 23269131Barr 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.
- Background: PubMed 8470867Benjamin 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.
- Background: PubMed 6367543Bishop MJ, Weymuller EA Jr, Fink BR. Laryngeal effects of prolonged intubation. Anesth Analg. 1984 Mar;63(3):335-42. No abstract available.
- Background: PubMed 3718696Brandwein 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.
- Background: PubMed 30096101Brodsky 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.
- Background: PubMed 2791687Colice GL, Stukel TA, Dain B. Laryngeal complications of prolonged intubation. Chest. 1989 Oct;96(4):877-84. doi: 10.1378/chest.96.4.877.
- Background: PubMed 1736742Colice 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.
- Background: PubMed 5347141Donnelly WH. Histopathology of endotracheal intubation. An autopsy study of 99 cases. Arch Pathol. 1969 Nov;88(5):511-20. No abstract available.
- Background: PubMed 569990Dubick 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.
- Background: PubMed 3766091Eckerbom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale M. Needham, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, Intratracheal and Critical Illness, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laryngeal injury as assessed by 4-point categorical scale (time frame: Within 72 hours post-extubation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03726086, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.