Complication of Ventilation Therapy, Critical Illness, Intubation, Intratracheal, Mechanical Ventilation Complication
Conditions
Keywords
larynx, injury, voice, trachea
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).
Interventions
DIAGNOSTIC_TESTlaryngoscopy
A flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway.
Sponsors
National Institute of Nursing Research (NINR)
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laryngeal injury as assessed by 4-point categorical scale | 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) | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceptual voice characteristics as assessed by GRBAS method | 7 days post-extubation or hospital discharge, whichever occurs first | 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). |
| Acoustic voice measurement as assessed by voice analysis software | Within 72 hours post-extubation | 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 |
| Patient perception of voice and voice symptoms assessed by the Voice Symptom Scale (VoiSS) | Within 72 hours post-extubation and at 7 days post-extubation or hospital discharge, whichever occurs first | a 30-item questionnaire that uses scaled scores across 3 domains-impairment (15 items), physical symptoms (8 items), and emotional response (7 items). |
| Oral endotracheal tube size | At the time of intubation (directly following study enrollment) | Size of the endotracheal tube |
| Peak tongue strength 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 | Tongue strength, tested using tongue bulb pressure, will be assessed using the Iowa Oral Performance Instrument (IOPI) |
| Yale Swallow Protocol | Within 72 hours post-extubation | 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. |
| Function Oral Intake Scale (FOIS) | Within 90 days of extubation or at ICU discharge, whichever occurs first | A 7-point clinical scale to document change in functional oral intake of food and liquid in patients. |
| Isometric Hand Grip Strength-Dynamometry | Within 48 hours of anticipated extubation, within 72 hours post-extubation, and at 7 days post-extubation or hospital discharge, whichever occurs first | 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 |
| 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 | Number of days from placement to extubation of the oral endotracheal tube |
| Perceptual voice characteristics as assessed by Grade Rough Breathy Asthenic Strained (GRBAS) method | Within 72 hours post-extubation | 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). |
Countries
United States
Outcome results
None listed