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Comparative Treatment Outcomes for Patients With Idiopathic Subglottic Stenosis.
Gelbard A, Anderson C, Berry LD, Amin MR, Benninger MS, Blumin JH, Bock JM, Bryson PC, Castellanos PF, Chen SC, Clary MS, Cohen SM, Crawley BK, Dailey SH, Daniero JJ, de Alarcon A, Donovan DT, Edell ES, Ekbom DC, Fernandes-Taylor S, Fink DS, Franco RA, Garrett CG, Guardiani EA, Hillel AT, Hoffman HT, Hogikyan ND, Howell RJ, Huang LC, Hussain LK, Johns MM, Kasperbauer JL, Khosla SM, Kinnard C, Kupfer RA, Langerman AJ, Lentz RJ, Lorenz RR, Lott DG, Lowery AS, Makani SS, Maldonado F, Mannion K, Matrka L, McWhorter AJ, Merati AL, Mori MC, Netterville JL, O'Dell K, Ongkasuwan J, Postma GN, Reder LS, Rohde SL, Richardson BE, Rickman OB, Rosen CA, Rutter MJ, Sandhu GS, Schindler JS, Schneider GT, Shah RN, Sikora AG, Sinard RJ, Smith ME, Smith LJ, Soliman AMS, Sveinsdóttir S, Van Daele DJ, Veivers D, Verma SP, Weinberger PM, Weissbrod PA, Wootten CT, Shyr Y, Francis DO
(2020) JAMA Otolaryngol Head Neck Surg 146: 20-29
MeSH Terms: Adult, Cricoid Cartilage, Female, Humans, Laryngoscopy, Laryngostenosis, Male, Middle Aged, Prospective Studies, Quality of Life, Reoperation, Surveys and Questionnaires, Treatment Outcome
Show Abstract · Added July 30, 2020
Importance - Surgical treatment comparisons in rare diseases are difficult secondary to the geographic distribution of patients. Fortunately, emerging technologies offer promise to reduce these barriers for research.
Objective - To prospectively compare the outcomes of the 3 most common surgical approaches for idiopathic subglottic stenosis (iSGS), a rare airway disease.
Design, Setting, and Participants - In this international, prospective, 3-year multicenter cohort study, 810 patients with untreated, newly diagnosed, or previously treated iSGS were enrolled after undergoing a surgical procedure (endoscopic dilation [ED], endoscopic resection with adjuvant medical therapy [ERMT], or cricotracheal resection [CTR]). Patients were recruited from clinician practices in the North American Airway Collaborative and an online iSGS community on Facebook.
Main Outcomes and Measures - The primary end point was days from initial surgical procedure to recurrent surgical procedure. Secondary end points included quality of life using the Clinical COPD (chronic obstructive pulmonary disease) Questionnaire (CCQ), Voice Handicap Index-10 (VHI-10), Eating Assessment Test-10 (EAT-10), the 12-Item Short-Form Version 2 (SF-12v2), and postoperative complications.
Results - Of 810 patients in this cohort, 798 (98.5%) were female and 787 (97.2%) were white, with a median age of 50 years (interquartile range, 43-58 years). Index surgical procedures were ED (n = 603; 74.4%), ERMT (n = 121; 14.9%), and CTR (n = 86; 10.6%). Overall, 185 patients (22.8%) had a recurrent surgical procedure during the 3-year study, but recurrence differed by modality (CTR, 1 patient [1.2%]; ERMT, 15 [12.4%]; and ED, 169 [28.0%]). Weighted, propensity score-matched, Cox proportional hazards regression models showed ED was inferior to ERMT (hazard ratio [HR], 3.16; 95% CI, 1.8-5.5). Among successfully treated patients without recurrence, those treated with CTR had the best CCQ (0.75 points) and SF-12v2 (54 points) scores and worst VHI-10 score (13 points) 360 days after enrollment as well as the greatest perioperative risk.
Conclusions and Relevance - In this cohort study of 810 patients with iSGS, endoscopic dilation, the most popular surgical approach for iSGS, was associated with a higher recurrence rate compared with other procedures. Cricotracheal resection offered the most durable results but showed the greatest perioperative risk and the worst long-term voice outcomes. Endoscopic resection with medical therapy was associated with better disease control compared with ED and had minimal association with vocal function. These results may be used to inform individual patient treatment decision-making.
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13 MeSH Terms
The impact of social determinants of health on laryngotracheal stenosis development and outcomes.
Dang S, Shinn JR, Campbell BR, Garrett G, Wootten C, Gelbard A
(2020) Laryngoscope 130: 1000-1006
MeSH Terms: Adult, Aged, Aged, 80 and over, Critical Care, Female, Follow-Up Studies, Humans, Laryngoscopy, Laryngostenosis, Male, Middle Aged, Retrospective Studies, Risk Factors, Social Determinants of Health, Time Factors, Tracheal Stenosis, Treatment Outcome, Young Adult
Show Abstract · Added July 30, 2020
OBJECTIVES - The social determinants of health affect a wide range of health outcomes and risks. To date, there have been no studies evaluating the impact of social determinants of health on laryngotracheal stenosis (LTS). We sought to describe the social determinants in a cohort of LTS patients and explore their association with treatment outcome.
METHODS - Subjects diagnosed with LTS undergoing surgical procedures between 2013 and 2018 were identified. Matched controls were identified from intensive care unit (ICU) patients who underwent intubation for greater than 24 hours. Medical comorbidities, stenosis characteristics, and patient demographics were abstracted from the clinical record. Tracheostomy at last follow-up was recorded from the medical record and phone calls. Socioeconomic data was obtained from the American Community Survey.
RESULTS - One hundred twenty-two cases met inclusion criteria. Cases had significantly lower education compared to Tennessee (P = .009) but similar education rates as ICU controls. Cases had significantly higher body mass index (odds ratio [OR]: 1.04, P = .035), duration of intubation (OR: 1.21, P < .001), and tobacco use (OR: 1.21, P = .006) in adjusted analysis when compared to controls. Tracheostomy dependence within the case cohort was significantly associated with public insurance (OR: 1.33, P = .016) and chronic obstructive pulmonary disease (OR: 1.34, P = .018) in adjusted analysis.
CONCLUSION - Intubation practices, medical comorbidities and social determinants of health may influence the development of LTS and tracheostomy dependence after treatment. Identification of at-risk populations in ICUs may allow for prevention of tracheostomy dependence through the use of early tracheostomy and specialized follow-up.
LEVEL OF EVIDENCE - Level 3, retrospective review comparing cases and controls Laryngoscope, 130:1000-1006, 2020.
© 2019 The American Laryngological, Rhinological and Otological Society, Inc.
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18 MeSH Terms
Early Surgical Management of Thermal Airway Injury: A Case Series.
Jayawardena A, Lowery AS, Wootten C, Dion GR, Summitt JB, McGrane S, Gelbard A
(2019) J Burn Care Res 40: 189-195
MeSH Terms: Adrenal Cortex Hormones, Adult, Anti-Bacterial Agents, Azithromycin, Burns, Inhalation, Cicatrix, Humans, Immunity, Mucosal, Interleukin-17, Laryngoscopy, Male, Reconstructive Surgical Procedures, Skin Transplantation, Stents, Tracheostomy
Show Abstract · Added July 30, 2020
Inhalation injury is an independent risk factor in burn mortality, imparting a 20% increased risk of death. Yet there is little information on the natural history, functional outcome, or pathophysiology of thermal injury to the laryngotracheal complex, limiting treatment progress. This paper demonstrates a case series (n = 3) of significant thermal airway injuries. In all cases, the initial injury was far exceeded by the subsequent immune response and aggressive fibroinflammatory healing. Serial examination demonstrated progressive epithelial injury, mucosal inflammation, airway remodeling, and luminal compromise. Histologic findings in the first case demonstrate an early IL-17A response in the human airway following thermal injury. This is the first report implicating IL-17A in the airway mucosal immune response to thermal injury. Their second and third patients received Azithromycin targeting IL-17A and showed clinical responses. The third patient also presented with exposed tracheal cartilage and underwent mucosal reconstitution via split-thickness skin graft over an endoluminal stent in conjunction with tracheostomy. This was associated with rapid abatement of mucosal inflammation, resolution of granulation tissue, and return of laryngeal function. Patients who present with thermal inhalation injury should receive a thorough multidisciplinary airway evaluation, including early otolaryngologic evaluation. New early endoscopic approaches (scar lysis and mucosal reconstitution with autologous grafting over an endoluminal stent), when combined with targeted medical therapy aimed at components of mucosal airway inflammation (local corticosteroids and systemic Azithromycin targeting IL-17A), may have potential to limit chronic cicatricial complications.
© American Burn Association 2018. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults.
Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW, Check-UP Investigators*, Pragmatic Critical Care Research Group
(2018) Chest 153: 816-824
MeSH Terms: Airway Management, Checklist, Critical Care, Critical Illness, Female, Humans, Intubation, Intratracheal, Laryngoscopy, Male, Middle Aged, Oxygen, Partial Pressure, Patient Positioning, Treatment Outcome
Show Abstract · Added May 17, 2021
BACKGROUND - Hypoxemia and hypotension are common complications during endotracheal intubation of critically ill adults. Verbal performance of a written, preintubation checklist may prevent these complications. We compared a written, verbally performed, preintubation checklist with usual care regarding lowest arterial oxygen saturation or lowest systolic BP experienced by critically ill adults undergoing endotracheal intubation.
METHODS - A multicenter trial in which 262 adults undergoing endotracheal intubation were randomized to a written, verbally performed, preintubation checklist (checklist) or no preintubation checklist (usual care). The coprimary outcomes were lowest arterial oxygen saturation and lowest systolic BP between the time of procedural medication administration and 2 min after endotracheal intubation.
RESULTS - The median lowest arterial oxygen saturation was 92% (interquartile range [IQR], 79-98) in the checklist group vs 93% (IQR, 84-100) with usual care (P = .34). The median lowest systolic BP was 112 mm Hg (IQR, 94-133) in the checklist group vs 108 mm Hg (IQR, 90-132) in the usual care group (P = .61). There was no difference between the checklist and usual care in procedure duration (120 vs 118 s; P = .49), number of laryngoscopy attempts (one vs one attempt; P = .42), or severe life-threatening procedural complications (40.8% vs 32.6%; P = .20).
CONCLUSIONS - The verbal performance of a written, preprocedure checklist does not increase the lowest arterial oxygen saturation or lowest systolic BP during endotracheal intubation of critically ill adults compared with usual care.
TRIAL REGISTRY - ClinicalTrials.gov; No.: NCT02497729; URL: www.clinicaltrials.gov.
Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
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A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults.
Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW, Check-UP Investigators(∗), Pragmatic Critical Care Research Group
(2017) Chest 152: 712-722
MeSH Terms: Adult, Aged, Critical Illness, Female, Follow-Up Studies, Humans, Hypoxia, Intensive Care Units, Intubation, Intratracheal, Laryngoscopy, Male, Middle Aged, Patient Positioning, Posture, Retrospective Studies, Treatment Outcome
Show Abstract · Added May 17, 2021
BACKGROUND - Hypoxemia is the most common complication during endotracheal intubation of critically ill adults. Intubation in the ramped position has been hypothesized to prevent hypoxemia by increasing functional residual capacity and decreasing the duration of intubation, but has never been studied outside of the operating room.
METHODS - Multicenter, randomized trial comparing the ramped position (head of the bed elevated to 25°) with the sniffing position (torso supine, neck flexed, and head extended) among 260 adults undergoing endotracheal intubation by pulmonary and critical care medicine fellows in four ICUs between July 22, 2015, and July 19, 2016. The primary outcome was lowest arterial oxygen saturation between induction and 2 minutes after intubation. Secondary outcomes included Cormack-Lehane grade of glottic view, difficulty of intubation, and number of laryngoscopy attempts.
RESULTS - The median lowest arterial oxygen saturation was 93% (interquartile range [IQR], 84%-99%) with the ramped position vs 92% (IQR, 79%-98%) with the sniffing position (P = .27). The ramped position appeared to increase the incidence of grade III or IV view (25.4% vs 11.5%, P = .01), increase the incidence of difficult intubation (12.3% vs 4.6%, P = .04), and decrease the rate of intubation on the first attempt (76.2% vs 85.4%, P = .02), respectively.
CONCLUSIONS - In this multicenter trial, the ramped position did not improve oxygenation during endotracheal intubation of critically ill adults compared with the sniffing position. The ramped position may worsen glottic view and increase the number of laryngoscopy attempts required for successful intubation.
TRIAL REGISTRY - ClinicalTrials.gov; No.: NCT02497729; URL: www.clinicaltrials.gov.
Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
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Randomized Trial of Video Laryngoscopy for Endotracheal Intubation of Critically Ill Adults.
Janz DR, Semler MW, Lentz RJ, Matthews DT, Assad TR, Norman BC, Keriwala RD, Ferrell BA, Noto MJ, Shaver CM, Richmond BW, Zinggeler Berg J, Rice TW, Facilitating EndotracheaL intubation by Laryngoscopy technique and apneic Oxygenation Within the ICU Investigators and the Pragmatic Critical Care Research Group
(2016) Crit Care Med 44: 1980-1987
MeSH Terms: Academic Medical Centers, Aged, Carbon Dioxide, Critical Illness, Female, Hospital Mortality, Humans, Intensive Care Units, Intubation, Intratracheal, Laryngoscopy, Length of Stay, Male, Middle Aged, Oxygen, Prospective Studies, Respiration, Artificial, Time Factors, Video Recording
Show Abstract · Added March 30, 2020
OBJECTIVE - To evaluate the effect of video laryngoscopy on the rate of endotracheal intubation on first laryngoscopy attempt among critically ill adults.
DESIGN - A randomized, parallel-group, pragmatic trial of video compared with direct laryngoscopy for 150 adults undergoing endotracheal intubation by Pulmonary and Critical Care Medicine fellows.
SETTING - Medical ICU in a tertiary, academic medical center.
PATIENTS - Critically ill patients 18 years old or older.
INTERVENTIONS - Patients were randomized 1:1 to video or direct laryngoscopy for the first attempt at endotracheal intubation.
MEASUREMENTS AND MAIN RESULTS - Patients assigned to video (n = 74) and direct (n = 76) laryngoscopy were similar at baseline. Despite better glottic visualization with video laryngoscopy, there was no difference in the primary outcome of intubation on the first laryngoscopy attempt (video 68.9% vs direct 65.8%; p = 0.68) in unadjusted analyses or after adjustment for the operator's previous experience with the assigned device (odds ratio for video laryngoscopy on intubation on first attempt 2.02; 95% CI, 0.82-5.02, p = 0.12). Secondary outcomes of time to intubation, lowest arterial oxygen saturation, complications, and in-hospital mortality were not different between video and direct laryngoscopy.
CONCLUSIONS - In critically ill adults undergoing endotracheal intubation, video laryngoscopy improves glottic visualization but does not appear to increase procedural success or decrease complications.
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Novel application of the Sonopet for endoscopic posterior split and cartilage graft laryngoplasty.
Yawn RJ, Daniero JJ, Gelbard A, Wootten CT
(2016) Laryngoscope 126: 941-4
MeSH Terms: Adult, Aged, Cartilage, Cricoid Cartilage, Electrocoagulation, Female, Humans, Laryngoplasty, Laryngoscopy, Laryngostenosis, Male, Middle Aged, Retrospective Studies, Tracheotomy, Treatment Outcome
Added January 25, 2017
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15 MeSH Terms
Disease homogeneity and treatment heterogeneity in idiopathic subglottic stenosis.
Gelbard A, Donovan DT, Ongkasuwan J, Nouraei SA, Sandhu G, Benninger MS, Bryson PC, Lorenz RR, Tierney WS, Hillel AT, Gadkaree SK, Lott DG, Edell ES, Ekbom DC, Kasperbauer JL, Maldonado F, Schindler JS, Smith ME, Daniero JJ, Garrett CG, Netterville JL, Rickman OB, Sinard RJ, Wootten CT, Francis DO
(2016) Laryngoscope 126: 1390-6
MeSH Terms: Airway Obstruction, Female, Follow-Up Studies, Humans, Laryngoscopy, Laryngostenosis, Larynx, Male, Middle Aged, Recurrence, Retrospective Studies, Tracheostomy, Treatment Outcome
Show Abstract · Added February 1, 2016
OBJECTIVES/HYPOTHESIS - Idiopathic subglottic stenosis (iSGS) is a rare and potentially life-threatening disease marked by recurrent and progressive airway obstruction frequently requiring repeated surgery to stabilize the airway. Unknown etiology and low disease prevalence have limited the ability to characterize the natural history of iSGS and resulted in variability in surgical management. It is uncertain how this variation relates to clinical outcomes.
STUDY DESIGN - Medical record abstraction.
METHODS - Utilizing an international, multi-institutional collaborative, we collected retrospective data on patient characteristics, treatment, and clinical outcomes. We investigated variation between and within open and endoscopic treatment approaches and assessed therapeutic outcomes; specifically, disease recurrence and need for tracheostomy at last follow-up.
RESULTS - Strikingly, 479 iSGS patients across 10 participating centers were nearly exclusively female (98%, 95% confidence interval [CI], 96.1-99.6), Caucasian (95%, 95% CI, 92.2-98.8), and otherwise healthy (mean age-adjusted Charlson Comorbidity Index 1.5; 95% CI, 1.44-1.69). The patients presented at a mean age of 50 years (95% CI, 48.8-51.1). A total of 80.2% were managed endoscopically, whereas 19.8% underwent open reconstruction. Endoscopic surgery had a significantly higher rate of disease recurrence than the open approach (chi(2) = 4.09, P = 0.043). Tracheostomy was avoided in 97% of patients irrespective of surgical approach (95% CI, 94.5-99.8). Interestingly, there were outliers in rates of disease recurrence between centers using similar treatment approaches.
CONCLUSION - Idiopathic subglottic stenosis patients are surprisingly homogeneous. The heterogeneity of treatment approaches and the observed outliers in disease recurrence rates between centers raises the potential for improved clinical outcomes through a detailed understanding of the processes of care.
LEVEL OF EVIDENCE - 4. Laryngoscope, 126:1390-1396, 2016.
© 2015 The American Laryngological, Rhinological and Otological Society, Inc.
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13 MeSH Terms
Severe bradycardia associated with suspension laryngoscopy.
Latuska RF, Kuhl NO, Garrett CG, Berry JM, Gelbard A
(2016) Laryngoscope 126: 949-50
MeSH Terms: Bradycardia, Humans, Laryngoscopy, Male, Middle Aged
Show Abstract · Added January 25, 2017
Suspension laryngoscopy is one of the most common procedures performed for visualizing and diagnosing diseases of the larynx. A relatively uncommon yet potentially life-threatening complication is that of severe bradycardia or asystole during manipulation of the larynx. This case report highlights the occurrence of this complication during a routine removal of a true vocal fold lesion at a tertiary medical center and discusses the potential pathophysiological mechanisms and proposed management options for this phenomenon.
© 2015 The American Laryngological, Rhinological and Otological Society, Inc.
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5 MeSH Terms
Randomized Trial of Apneic Oxygenation during Endotracheal Intubation of the Critically Ill.
Semler MW, Janz DR, Lentz RJ, Matthews DT, Norman BC, Assad TR, Keriwala RD, Ferrell BA, Noto MJ, McKown AC, Kocurek EG, Warren MA, Huerta LE, Rice TW, FELLOW Investigators, Pragmatic Critical Care Research Group
(2016) Am J Respir Crit Care Med 193: 273-80
MeSH Terms: Aged, Arteries, Critical Illness, Female, Humans, Intensive Care Units, Intubation, Intratracheal, Laryngoscopy, Male, Middle Aged, Oxygen
Show Abstract · Added May 17, 2021
RATIONALE - Hypoxemia is common during endotracheal intubation of critically ill patients and may predispose to cardiac arrest and death. Administration of supplemental oxygen during laryngoscopy (apneic oxygenation) may prevent hypoxemia.
OBJECTIVES - To determine if apneic oxygenation increases the lowest arterial oxygen saturation experienced by patients undergoing endotracheal intubation in the intensive care unit.
METHODS - This was a randomized, open-label, pragmatic trial in which 150 adults undergoing endotracheal intubation in a medical intensive care unit were randomized to receive 15 L/min of 100% oxygen via high-flow nasal cannula during laryngoscopy (apneic oxygenation) or no supplemental oxygen during laryngoscopy (usual care). The primary outcome was lowest arterial oxygen saturation between induction and 2 minutes after completion of endotracheal intubation.
MEASUREMENTS AND MAIN RESULTS - Median lowest arterial oxygen saturation was 92% with apneic oxygenation versus 90% with usual care (95% confidence interval for the difference, -1.6 to 7.4%; P = 0.16). There was no difference between apneic oxygenation and usual care in incidence of oxygen saturation less than 90% (44.7 vs. 47.2%; P = 0.87), oxygen saturation less than 80% (15.8 vs. 25.0%; P = 0.22), or decrease in oxygen saturation greater than 3% (53.9 vs. 55.6%; P = 0.87). Duration of mechanical ventilation, intensive care unit length of stay, and in-hospital mortality were similar between study groups.
CONCLUSIONS - Apneic oxygenation does not seem to increase lowest arterial oxygen saturation during endotracheal intubation of critically ill patients compared with usual care. These findings do not support routine use of apneic oxygenation during endotracheal intubation of critically ill adults. Clinical trial registered with www.clinicaltrials.gov (NCT 02051816).
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