Early medical therapy for acute laryngeal injury (ALgI) following endotracheal intubation: a protocol for a prospective single-centre randomised controlled trial.
ABSTRACT: INTRODUCTION:Respiratory failure requiring endotracheal intubation accounts for a significant proportion of intensive care unit (ICU) admissions. Little attention has been paid to the laryngeal consequences of endotracheal intubation. Acute laryngeal injury (ALgI) after intubation occurs at the mucosal interface of the endotracheal tube and posterior larynx and although not immediately manifest at extubation, can progress to mature fibrosis, restricted glottic mobility and clinically significant ventilatory impairment. A recent prospective observational study has shown that >50% of patients intubated >24 hours in an ICU develop ALgI. Strikingly, patients with AlgI manifest significantly worse subjective breathing at 12 weeks. Current ALgI treatments are largely surgical yet offer a marginal improvement in symptoms. In this study, we will examine the ability of a postextubation medical regime (azithromycin and inhaled budesonide) to improve breathing 12 weeks after ALgI. METHODS AND ANALYSIS: A prospective, single-centre, double-blinded, randomised, control trial will be conducted at Vanderbilt Medical Center. Participants will be recruited from adult patients in ICUs. Participants will undergo a bedside flexible nasolaryngoscopy for the identification of ALgI within 72 hours postextubation. In addition, participants will be asked to complete peak expiratory flow measurements immediately postintubation. Patients found to have ALgI will be randomised to the placebo control or medical therapy group (azithromycin 250 mg and budesonide 0.5 mg for 14 days). Repeat peak expiratory flow, examination of the larynx and patient-reported Clinical COPD (chronic obstructive pulmonary disease) Questionnaire, Voice Handicap Index and 12-Item Short Form Health Survey questionnaires will be conducted at 12 weeks postextubation. Consented patients will also have patient-specific, disease-specific and procedure-specific covariates abstracted from their medical record. ETHICS AND DISSEMINATION:The Institutional Review Board (IRB) Committee of the Vanderbilt University Medical Center has approved this protocol (IRB #171066). The findings of the trial will be disseminated through peer-reviewed journals, national and international conferences. TRIAL REGISTRATION NUMBER:NCT03250975.
Project description:OBJECTIVES:To systematically review the symptoms and types of laryngeal injuries resulting from endotracheal intubation in mechanically ventilated patients in the ICU. DATA SOURCES:PubMed, Embase, CINAHL, and Cochrane Library from database inception to September 2017. STUDY SELECTION:Studies of adult patients who were endotracheally intubated with mechanical ventilation in the ICU and completed postextubation laryngeal examinations with either direct or indirect visualization. DATA EXTRACTION:Independent, double-data extraction and risk of bias assessment followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Risk of bias assessment followed the Cochrane Collaboration's criteria. DATA SYNTHESIS:Nine studies (seven cohorts, two cross-sectional) representing 775 patients met eligibility criteria. The mean (SD; 95% CI) duration of intubation was 8.2 days (6.0 d; 7.7-8.7 d). A high prevalence (83%) of laryngeal injury was found. Many of these were mild injuries, although moderate to severe injuries occurred in 13-31% of patients across studies. The most frequently occurring clinical symptoms reported post extubation were dysphonia (76%), pain (76%), hoarseness (63%), and dysphagia (49%) across studies. CONCLUSIONS:Laryngeal injury from intubation is common in the ICU setting. Guidelines for laryngeal assessment and postextubation surveillance do not exist. A systematic approach to more robust investigations could increase knowledge of the association between particular injuries and corresponding functional impairments, improving understanding of both time course and prognosis for resolution of injury. Our findings identify targets for future research and highlight the long-known, but understudied, clinical outcomes from endotracheal intubation with mechanical ventilation in ICU.
Project description:PURPOSE:Upper airway stenosis is one of the most formidable situations in medicine and is frequently encountered in the ENT clinic. We introduce here our method of emergency endonasal endotracheal intubation under videoendoscopic observation. METHODS:Transnasal endoscopic observation was done, and the region of airway stenosis was detected. Then, the endotracheal tube was prepared and the endoscope was inserted into the tube. The endoscope with tube was inserted up to the larynx. Immediately after the administration of lidocaine to the larynx, the endoscope with tube was inserted to the endolarynx and then to the trachea. The endotracheal tube was tightly held in the nostril, and the endoscope was removed. RESULTS:We have encountered four cases this year. The primary disease developing airway stenosis was acute epiglottitis due to pharyngeal and deep neck abscesses in three cases and laryngeal edema due to Ludwig's angina. All patients underwent uneventful intubation, and dyspnea was immediately ceased. CONCLUSION:In cases showing severe suffocation, the clinician should perform airway maintenance even in an outpatient setting apart from a more monitored setting like the operation room. This technique resembles the usual nasal endoscopic laryngeal observation and is done even in the usual ENT office and/or emergency room. The supine position tends to worsen airway stenosis in patients with upper airway stenosis; however, this technique can be performed in a sitting or semi-sitting position. This method is less invasive for patients and also reduces the risk to the medical staff, especially in this COVID-19 era.
Project description:We evaluated the effect of two drugs with anti-inflammatory action, dexamethasone and ketorolac, on reduction of postoperative sore throat (POST) after general anesthesia with endotracheal intubation in patients undergoing thyroidectomy.One hundred and ninety-two female patients scheduled to undergo general anesthesia with endotracheal intubation for thyroidectomy were enrolled in this prospective study. Participants were randomly allocated to receive intravenous medication; placebo (Group C, n = 45), ketorolac 30 mg immediately before intubation (Group Kpre, n = 47), ketorolac 30 mg at the end of surgery (Group Kpost, n = 45) and dexamethasone 10 mg (Group D, n = 43). The incidence and severity of POST and hoarseness were evaluated at 1, 6 and 24 hours after surgery.Incidences and severities of POST at rest and during swallowing in first 6 hours after extubation were comparable among 4 groups. At 24 hours postextubation, the incidence (P = 0.002, 95% CI of proportion differences; 0.05-0.39) and severity (P = 0.008) of POST during swallowing were significantly lower in group D than in group C. Kpre and Kpost groups did not show a greater reduction in POST than group C, despite lower rescue analgesic requirement at 1 hour after extubation in group Kpre (P = 0.006; 95% CI of proportion differences; 0.07-0.38). No intergroup differences were observed in incidences of hoarseness or adverse events.Intravenous administration of dexamethasone 10 mg, but not ketorolac, before induction of anesthesia reduces the incidence and severity of POST during swallowing at 24 hours after thyroidectomy.
Project description: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.
Project description:OBJECTIVE:Hypotension following endotracheal intubation in the ICU is associated with poor outcomes. There is no formal prediction tool to help estimate the onset of this hemodynamic compromise. Our objective was to derive and validate a prediction model for immediate hypotension following endotracheal intubation. METHODS:A multicenter, prospective, cohort study enrolling 934 adults who underwent endotracheal intubation across 16 medical/surgical ICUs in the United States from July 2015-January 2017 was conducted to derive and validate a prediction model for immediate hypotension following endotracheal intubation. We defined hypotension as: 1) mean arterial pressure <65 mmHg; 2) systolic blood pressure <80 mmHg and/or decrease in systolic blood pressure of 40% from baseline; 3) or the initiation or increase in any vasopressor in the 30 minutes following endotracheal intubation. RESULTS:Post-intubation hypotension developed in 344 (36.8%) patients. In the full cohort, 11 variables were independently associated with hypotension: increasing illness severity; increasing age; sepsis diagnosis; endotracheal intubation in the setting of cardiac arrest, mean arterial pressure <65 mmHg, and acute respiratory failure; diuretic use 24 hours preceding endotracheal intubation; decreasing systolic blood pressure from 130 mmHg; catecholamine and phenylephrine use immediately prior to endotracheal intubation; and use of etomidate during endotracheal intubation. A model excluding unstable patients' pre-intubation (those receiving catecholamine vasopressors and/or who were intubated in the setting of cardiac arrest) was also developed and included the above variables with the exception of sepsis and etomidate. In the full cohort, the 11 variable model had a C-statistic of 0.75 (95% CI 0.72, 0.78). In the stable cohort, the 7 variable model C-statistic was 0.71 (95% CI 0.67, 0.75). In both cohorts, a clinical risk score was developed stratifying patients' risk of hypotension. CONCLUSIONS:A novel multivariable risk score predicted post-intubation hypotension with accuracy in both unstable and stable critically ill patients. STUDY REGISTRATION:Clinicaltrials.gov identifier: NCT02508948 and Registered Report Identifier: RR2-10.2196/11101.
Project description:Endotracheal intubation success rates in the prehospital setting are variable. Our objective was to describe the challenges encountered and corrective actions taken during the process of endotracheal intubation by paramedics.Analysis of prehospital airway management using a prospective registry that was linked to an emergency medical services administrative database.Emergency medical services system serving King County, Washington, 2006-2011. Paramedics in this system have the capability to administer neuromuscular blocking agents to facilitate intubation (i.e., rapid sequence intubation).A total of 7,523 patients more than 12 years old in whom paramedics attempted prehospital endotracheal intubation.None.An intubation attempt was defined as the introduction of the laryngoscope into the patient's mouth, and the attempt concluded when the laryngoscope was removed from the mouth. Endotracheal intubation was successful on the first attempt in 77% and ultimately successful in 99% of patients (7,433 of 7,523). Paramedics used a rapid sequence intubation strategy on 54% of first attempts. Among the subset with a failed first attempt (n = 1,715), bodily fluids obstructing the laryngeal view (50%), obesity (28%), patient positioning (17%), and facial or spinal trauma (6%) were identified as challenges to intubation. A variety of adjustments were made to achieve intubation success, including upper airway suctioning (used in 43% of attempts resulting in success), patient repositioning (38%), rescue bougie use (19%), operator change (16%), and rescue rapid sequence intubation (6%). Surgical cricothyrotomy (0.4%, n = 27) and bag-valve-mask ventilation (0.8%, n = 60) were rarely performed by paramedics as final rescue airway strategies.Airway management in the prehospital setting has substantial challenges. Success can require a collection of adjustments that involve equipment, personnel, and medication often in a simultaneous fashion.
Project description:Importance:The tracheal tube introducer, known as the bougie, is typically used to aid tracheal intubation in poor laryngoscopic views or after intubation attempts fail. The effect of routine bougie use on first-attempt intubation success is unclear. Objective:To compare first attempt intubation success facilitated by the bougie vs the endotracheal tube + stylet. Design, Setting, and Patients:The Bougie Use in Emergency Airway Management (BEAM) trial was a randomized clinical trial conducted from September 2016 through August 2017 in the emergency department at Hennepin County Medical Center, an urban, academic department in Minneapolis, Minnesota, where emergency physicians perform all endotracheal intubations. Included patients were 18 years and older who were consecutively admitted to the emergency department and underwent emergency orotracheal intubation with a Macintosh laryngoscope blade for respiratory arrest, difficulty breathing, or airway protection. Interventions:Patients were randomly assigned to undergo the initial intubation attempt facilitated by bougie (n = 381) or endotracheal tube + stylet (n = 376). Main Outcomes and Measures:The primary outcome was first-attempt intubation success in patients with at least 1 difficult airway characteristic (body fluids obscuring the laryngeal view, airway obstruction or edema, obesity, short neck, small mandible, large tongue, facial trauma, or the need for cervical spine immobilization). Secondary outcomes were first-attempt success in all patients, first-attempt intubation success without hypoxemia, first-attempt duration, esophageal intubation, and hypoxemia. Results:Among 757 patients who were randomized (mean age, 46 years; women, 230 [30%]), 757 patients (100%) completed the trial. Among the 380 patients with at least 1 difficult airway characteristic, first-attempt intubation success was higher in the bougie group (96%) than in the endotracheal tube + stylet group (82%) (absolute between-group difference, 14% [95% CI, 8% to 20%]). Among all patients, first-attempt intubation success in the bougie group (98%) was higher than the endotracheal tube + stylet group (87%) (absolute difference, 11% [95% CI, 7% to 14%]). The median duration of the first intubation attempt (38 seconds vs 36 seconds) and the incidence of hypoxemia (13% vs 14%) did not differ significantly between the bougie and endotracheal tube + stylet groups. Conclusions and Relevance:In this emergency department, use of a bougie compared with an endotracheal tube + stylet resulted in significantly higher first-attempt intubation success among patients undergoing emergency endotracheal intubation. However, these findings should be considered provisional until the generalizability is assessed in other institutions and settings. Trial Registration:clinicaltrials.gov Identifier: NCT02902146.
Project description:INTRODUCTION:Idiopathic subglottic stenosis (iSGS) is an unexplained progressive obstruction of the upper airway that occurs almost exclusively in adult, Caucasian women. The disease is characterised by mucosal inflammation and localised fibrosis resulting in life-threatening blockage of the upper airway. Because of high recurrence rates, patients with iSGS will frequently require multiple procedures following their initial diagnosis. Both the disease and its therapies profoundly affect patients' ability to breathe, communicate and swallow. A variety of treatments have been advanced to manage this condition. However, comparative data on effectiveness and side effects of the unique approaches have never been systematically evaluated. This study will create an international, multi-institutional prospective cohort of patients with iSGS. It will compare three surgical approaches to determine how well the most commonly used treatments in iSGS 'work' and what quality of life (QOL) trade-offs are associated with each approach. METHODS AND ANALYSIS:A prospective pragmatic trial comparing the 'Standard of Care' for iSGS at multiple international institutions. Patients with a diagnosis of iSGS without clinical or laboratory evidence of vasculitis or a history of endotracheal intubation 2?years prior to symptom onset will be included in the study. Prospective evaluation of disease recurrence requiring operative intervention, validated patient-reported outcome (PRO) measures as well as patient-generated health data (mobile peak flow recordings and daily steps taken) will be longitudinally tracked for 36?months. The primary endpoint is treatment effectiveness defined as time to recurrent operative procedure. Secondary endpoints relate to treatment side effects and include PRO measures in voice, swallowing, breathing and global QOL as well as patient-generated health data. ETHICS AND DISSEMINATION:This protocol was approved by the local IRB Committee of the Vanderbilt University Medical Center in July 2015. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and directly to patient with iSGS via social media-based support groups. TRIAL REGISTRATION NUMBER:NCT02481817.
Project description: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.To determine if apneic oxygenation increases the lowest arterial oxygen saturation experienced by patients undergoing endotracheal intubation in the intensive care unit.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.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.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).
Project description:OBJECTIVES:Premedication practices for neonatal tracheal intubations have not yet been described for neonatal transport teams. Our objective is to describe the use of sedation/analgesia (SA) for tracheal intubations and to assess its tolerance in neonates transported by medical transport teams in France. SETTING:This prospective observational study was part of the EPIPPAIN 2 project and collected around-the-clock data on SA practices in neonates intubated by all five paediatric medical transport teams of the Paris region during a 2-month period. Intubations were classified as emergent, semiemergent and non-emergent. Sedation level and conditions of intubation were assessed with the Tonus, Reactivity, Awareness and Conditions of intubation to Help in Endotracheal intubation Assessment (TRACHEA score). The scores range from 0 to 10 representing an increasing ladder from adequate to inadequate sedation, and from excellent to very poor conditions of intubation. PARTICIPANTS:40 neonates intubated in 28 different centres. RESULTS:The mean (SD) age was 34.9 (3.9) weeks, and 62.5% were intubated in the delivery room. 30/40 (75%) of intubations were performed with the use of SA. In 18/30 (60.0%) intubations performed with SA, the drug regimen was the association of sufentanil and midazolam. Atropine was given in 19/40 intubations. From the 16, 21 and 3 intubations classified as emergent, semiemergent and non-emergent, respectively, 8 (50%), 19 (90.5%) and 3 (100%) were performed with SA premedication. 79.3% of intubations performed with SA had TRACHEA scores of 3 or less. 22/40 (55%) infants had at least one of the following adverse events: muscle rigidity, bradycardia below 100/min, desaturation below 80% and nose or pharynx-larynx bleeding. 7/24 (29.2%) of those who had only one attempt presented at least one of these adverse events compared with 15/16 (93.8%) of those who needed two or more attempts (p<0.001). CONCLUSION:SA premedication is largely feasible for tracheal intubations performed in neonates transported by medical transport teams including intubations judged as emergent or semiemergent. TRIAL REGISTRATION NUMBER:NCT01346813; Results.