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Endotracheal Intubation Among the Critically Ill: Protocol for a Multicenter, Observational, Prospective Study.

ABSTRACT: 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.

SUBMITTER: Smischney N

PROVIDER: S-EPMC6303735 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Endotracheal Intubation Among the Critically Ill: Protocol for a Multicenter, Observational, Prospective Study.

Smischney Nathan N Kashyap Rahul R Seisa Mohamed M Schroeder Darrell D Diedrich Daniel D

JMIR research protocols 20181207 12

<h4>Background</h4>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 o ...[more]

PMID: 30530463

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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: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:INTRODUCTION:Haemophagocytic lymphohistiocytosis (HLH) in adults is characterised by toxic immune activation and a sepsis-like syndrome, leading to high numbers of undiagnosed cases and mortality rates of up to 68%. Early diagnosis and specific immune suppressive treatment are mandatory to avoid fatal outcome, but the diagnostic criteria (HLH-2004) are adopted from paediatric HLH and have not been validated in adults. Experimental studies suggest biomarkers to sufficiently diagnose HLH. However, biomarkers for the diagnosis of adult HLH have not yet been investigated. METHODS AND ANALYSIS:The HEMICU (Diagnostic biomarkers for adult haemophagocytic lymphohistiocytosis in critically ill patients) study aims to estimate the incidence rate of adult HLH among suspected adult patients in intensive care units (ICUs). Screening for HLH will be performed in 16 ICUs of Charité - Universitätsmedizin Berlin. The inclusion criteria are bicytopaenia, hyperferritinaemia (?500?µg/L), fever or when HLH is suspected by the clinician. Over a period of 2?years, we expect inclusion of about 100 patients with suspected HLH. HLH will be diagnosed if at least five of the HLH-2004 criteria are fulfilled, together with an expert review; all other included patients will serve as controls. Second, a panel of potential biomarker candidates will be explored. DNA, plasma and serum will be stored in a biobank. The primary endpoint of the study is the incidence rate of adult HLH among suspected adult patients during ICU stay. Out of a variety of measured biomarkers, this study furthermore aims to find highly potential biomarkers for the diagnosis of adult HLH in ICU. The results of this study will contribute to improved recognition and patient outcome of adult HLH in clinical routine. ETHICS AND DISSEMINATION:The institutional ethics committee approved this study on 1 August 2018 (Ethics Committee of Charité - Universitätsmedizin Berlin, EA4/006/18). The results of the study will be disseminated in an international peer-reviewed journal and presented at international conferences. TRIAL REGISTRATION NUMBER:NCT03510650.

Dataset Information

Endotracheal Intubation Among the Critically Ill: Protocol for a Multicenter, Observational, Prospective Study.

Publications

Endotracheal Intubation Among the Critically Ill: Protocol for a Multicenter, Observational, Prospective Study.

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