Dataset Information

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.

SUBMITTER: Lowery AS

PROVIDER: S-EPMC6661707 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Early medical therapy for acute laryngeal injury (ALgI) following endotracheal intubation: a protocol for a prospective single-centre randomised controlled trial.

Lowery Anne S AS Kimura Kyle K Shinn Justin J Shannon Chevis C Gelbard Alexander A

BMJ open 20190727 7

<h4>Introduction</h4>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 sig ...[more]

PMID: 31352415

Similar Datasets

Project description:BACKGROUND:Endotracheal intubation can occur in up to 60% of critically ill patients. Despite the frequency with which endotracheal intubation occurs, the current practice is largely unknown. This is relevant, as advances in airway equipment (ie, video laryngoscopes) have become more prevalent, leading to possible improvement of care delivered during this process. In addition to new devices, a greater emphasis on airway plans and choices in sedation have evolved, although the influence on patient morbidity and mortality is largely unknown. OBJECTIVE:This study aims to derive and validate prediction models for immediate airway and hemodynamic complications of intensive care unit intubations. METHODS:A multicenter, observational, prospective study of adult critically ill patients admitted to both medical and surgical intensive care units (ICUs) was conducted. Participating ICU sites were located throughout eight health and human services regions of the United States for which endotracheal intubation was needed. A steering committee composed of both anesthesia and pulmonary critical care physicians proposed a core set of data variables. These variables were incorporated into a data collection form to be used within the multiple, participating ICUs across the United States during the time of intubation. The data collection form consisted of two basic components, focusing on airway management and hemodynamic management. The form was generated using RedCap and distributed to the participating centers. Quality checks on the dataset were performed several times with each center, such that they arrived at less than 10% missing values for each data variable; the checks were subsequently entered into a database. RESULTS:The study is currently undergoing data analysis. Results are expected in November 2018 with publication to follow thereafter. The study protocol has not yet undergone peer review by a funding body. CONCLUSIONS:The overall goal of this multicenter prospective study is to develop a scoring system for peri-intubation, hemodynamic, and airway-related complications so we can stratify those patients at greatest risk for decompensation as a result of these complications. This will allow critical care physicians to be better prepared in addressing these occurrences and will allow them to improve the quality of care delivered to the critically ill. TRIAL REGISTRATION:ClinicalTrials.gov NCT02508948; https://clinicaltrials.gov/ct2/show/NCT02508948 (Archived by WebCite at http://www.webcitation.org/73Oj6cTFu). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/11101.

Project description:INTRODUCTION:Tracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established. METHODS AND ANALYSIS:The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes. ETHICS AND DISSEMINATION:The study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57'". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications. TRIAL REGISTRATION DETAILS:ClinicalTrials.gov Identifier: NCT04079387; Pre-results.

Project description:ImportancePatients with laryngeal injury after endotracheal intubation often present long after initial injury with mature fibrosis compromising cricoarytenoid joint mobility and glottic function.ObjectiveTo compare functional outcomes between early and late intervention for intubation-related laryngeal injury.Design, setting, and participantsThis retrospective cohort study involved 29 patients with laryngeal injury resulting from endotracheal intubation who were evaluated at a tertiary care center between May 1, 2014, and June 1, 2018. Ten patients with intubation injury to the posterior glottis who received early treatment were compared with 19 patients presenting with posterior glottic stenosis who received late treatment. Statistical analysis was performed from May 1 to July 1, 2019.ExposuresEarly intervention, defined as a procedure performed 45 days or less after intubation, and late treatment, defined as an intervention performed greater than 45 days after intubation.Main outcomes and measuresPatient-specific and intervention-specific covariates were compared between the 2 groups, absolute differences with 95% CIs were calculated, and time to tracheostomy decannulation was compared using log-rank testing.ResultsThe 2 groups had similar demographic characteristics and a similar burden of comorbid disease. Ten patients who received early intervention (7 women [70%]; median age, 59.7 years [range, 31-72 years]; median, 34.7 days to presentation [IQR, 1.5-44.8 days]) were compared with 19 patients who received late intervention (11 women [58%]; median age, 53.8 years [range, 34-73 years]; median, 341.9 days to presentation [IQR, 132.7-376.3 days]). Nine of 10 patients (90%) who received early intervention and 11 of 19 patients (58%) who received late interventions were decannulated at last follow-up (absolute difference, 32%; 95% CI, -3% to 68%). Patients who received early treatment required fewer total interventions than patients with mature lesions (mean, 2.2 vs 11.5; absolute difference, 9.3; 95% CI, 6.4-12.1). In addition, none of the patients who received early treatment required an open procedure, whereas 17 patients (90%) with mature lesions required open procedures to pursue decannulation.Conclusions and relevanceThis study suggests that early intervention for patients with postintubation laryngeal injury was associated with a decreased duration of tracheostomy dependence, a higher rate of decannulation, and fewer surgical procedures compared with late intervention. Patients who underwent early intervention also avoided open reconstruction. These findings may bear relevance to the management of patients requiring extended durations of endotracheal intubation during recovery for critical illness related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Project description:BACKGROUND:The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version of the mask has been introduced. We compared the Fastrach single use with the new, low-priced single use intubating laryngeal mask Ambu Aura-i™. We hypothesised that the LMA Ambu Aura-i and the LMA Fastrach are comparable with respect to success rates for mask placement and blind tracheal intubation through the LMA device. METHODS:A prospective, randomised clinical trial. University Hospital Schleswig-Holstein, Campus Kiel, from April 2011 to April 2012. Eighty patients undergoing general anaesthesia with planned tracheal intubation were randomised and enrolled in the study. Blind intubation was performed with either laryngeal mask using two different tracheal tubes (Rüsch Super Safety Silk™ and LMA ETT™). A crossover-design was performed after an unsuccessful procedure. Primary outcome measure was the overall success rate of blind intubation. Secondary outcome measures were the time to the first adequate ventilation, a subjective handling score, and a fibreoptic control of placement, as well as the success rate of mask placement, time for mask removal after successful intubation, differences in airway leak pressure, and the incidence of postoperative sore throat and hoarseness. RESULTS:The success rate of tracheal intubation with the Fastrach for the first and second attempt was significantly better compared with the Ambu Aura-i. Tracheal intubation was also significantly faster (14.1 s. ±4.4 versus 21.3 s. ±9.0; p < 0.01), and the time interval for mask removal after successful intubation was significantly shorter using the Fastrach device (24.0 s. ±8.2 versus 29.4 s. ±7.5; p < 0.001). There were no significant differences between groups regarding the incidence of postoperative sore throat and hoarseness. CONCLUSION:Both laryngeal mask devices are suitable for ventilation and oxygenation. Blind intubation remains the domain of the LMA Fastrach, the Ambu Aura-i is not suitable for blind intubation. TRIAL REGISTRATION:Clinicaltrials.gov Identification Number NCT03109678 , retrospectively registered on April 12, 2017.

Dataset Information

Early medical therapy for acute laryngeal injury (ALgI) following endotracheal intubation: a protocol for a prospective single-centre randomised controlled trial.

Publications

Early medical therapy for acute laryngeal injury (ALgI) following endotracheal intubation: a protocol for a prospective single-centre randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure