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Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial.

ABSTRACT: BACKGROUND:Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or a prolonged vegetative state requiring long-term institutionalisation. Despite employing current best practices during RSI, desaturation during intubation still occurs. High-flow nasal cannula (HFNC) oxygenation may potentially improve oxygenation during pre- and apnoeic oxygenation to allow a longer safe apnoeic time for RSI. OBJECTIVE:We aim to test the hypothesis that the use of humidified high-flow oxygenation via nasal cannula at 60?L/min maintains higher oxygen saturation compared with current usual care of non-rebreather mask and standard nasal cannula at an oxygen flow rate of 15?L/min for pre- and apnoeic oxygenation. METHODS:This is a multi-centre randomised controlled trial enrolling adult patients aged 21 years and older who require rapid sequence intubation due to medical, surgical, or traumatic conditions in the Emergency Departments (EDs) of the National University Hospital and the Ng Teng Fong General Hospital. Eligible patients will undergo randomisation at an equal ratio into intervention or control arms. The primary endpoint will be the lowest oxygen saturation achieved during the first intubation attempt from time of administration of paralytic agent until quantitative end-tidal carbon dioxide is detected if the first intubation attempt is successful, or until the start of the second attempt if it is not. DISCUSSION:Prolongation of safe apnoea time through maintenance of oxygen saturation above 90% using HFNC oxygenation during RSI could potentially change current clinical practice, improve standard of care, and translate to better outcomes for patients. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03396094 . Registered on 10 January 2018.

SUBMITTER: Chua MT

PROVIDER: S-EPMC6449991 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial.

Chua Mui Teng MT Khan Faheem Ahmed FA Ng Wei Ming WM Lu Qingshu Q Low Matthew Jian Wen MJW Yau Ying Wei YW Punyadasa Amila A Kuan Win Sen WS

Trials 20190404 1

<h4>Background</h4>Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or a prolonged vegetative state requiring long-term institutionalisation. Despite employing current best practices during RSI, desaturation during intubation still occurs. High-flow nasal cannula (HFNC) oxygenation may potentially improve oxygenation during pre- and apnoeic ...[more]

PMID: 30947740

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Project description:IntroductionApnoeic oxygenation is a process of delivering continuous oxygen through nasal cannula during direct laryngoscopy. The oxygen that is delivered through these nasal cannulas is either low flow or high flow. Although the effectiveness of apnoeic oxygenation has been shown through systematic reviews and randomised controlled trials, a comparison of high-flow versus low-flow oxygen delivery has not been tested through a superiority study design. In this study we propose to assess the effectiveness of giving low-flow oxygen with head side elevation versus high-flow oxygen with head side elevation against the usual practice of care in which no oxygen is provided during direct laryngoscopy.Methods and analysisThis will be a three-arm study instituting a block randomisation technique with a sample size of 46 in each arm (see table 1). Due to the nature of the intervention, no blinding will be introduced. The primary outcomes will be lowest non-invasive oxygen saturation measurement during direct laryngoscopy and during the 2 min after the placement of the tube and the first pass success rate. The intervention constitutes head side elevation up to 30° for improving glottis visualisation together with low-flow or high-flow oxygen delivery through nasal cannula to increase safe apnoea time for participants undergoing endotracheal intubation. Primary analysis will be intention to treat.Ethics and disseminationThe study is approved by the Ethical Review Committee of Aga Khan University Hospital (2019-0726-2463). The project is an institution University Research Committee grant recipient 192 002ER-PK. The results of the study will be disseminated among participants, patient communities and healthcare professionals in the institution through seminars, presentations and emails. Further, the findings will be published in a highly accessed peer-reviewed medical journal and will be presented at both national and international conferences.Trial registration numberClinicalTrials.gov Registry (NCT04242537).

Project description:The Toronto Western Hospital is an academic hospital in Toronto, Canada, with an annual Emergency Department (ED) volume of 64,000 patients. Despite increases in patient volumes of almost six percent per annum over the last decade, there have been no commensurate increases in resources, infrastructure, and staffing. This has led to substantial increase in patient wait times, most specifically for those patients with lower acuity presentations. Despite requiring only minimal care, these patients contribute disproportionately to ED congestion, which can adversely impact resource utilization and quality of care for all patients. We undertook a retrospective evaluation of a quality improvement initiative aimed at improving wait times experienced by patients with lower acuity presentations. A rapid improvement event was organized by frontline workers to rapidly overhaul processes of care, leading to the creation of the Rapid Medical Evaluation (RME) unit - a new pathway of care for patients with lower acuity presentations. The RME unit was designed by re-purposing existing resources and re-assigning one physician and one nurse towards the specific care of these patients. We evaluated the performance of the RME unit through measurement of physician initial assessment (PIA) times and total length of stay (LOS) times for multiple groups of patients assigned to various ED care pathways, during three periods lasting three months each. Weekly measurements of mean and 90th percentile of PIA and LOS times showed special cause variation in all targeted patient groups. Of note, the patients seen in the RME unit saw their median PIA and LOS times decrease from 98min to 70min and from 165min to 130min, respectively, from baseline. Despite ever-growing numbers of patient visits, wait times for all patients with lower acuity presentations remained low, and wait times of patients with higher acuity presentations assigned to other ED care pathways were not adversely affected. By specifically re-purposing a fraction of existing staff, resources, and infrastructure for patients with lower acuity presentations, we were able to streamline their care and decrease wait times in the ED. These results were achieved through the incremental improvements afforded by rapidly cycling through PDSA cycles, with strong frontline staff involvement and continuously eliciting feedback for improvement. We believe the model to be replicable in other academic medical centres.

Project description:Emergency department (ED) crowding is an increasing problem associated with adverse patient outcomes. ED expansion is one method advocated to reduce ED crowding. The objective of this analysis was to determine the effect of ED expansion on measures of ED crowding.This was a retrospective study using administrative data from two 11-month periods before and after the expansion of an ED from 33 to 53 adult beds in an academic medical center. ED volume, staffing, and hospital admission and occupancy data were obtained either from the electronic health record (EHR) or from administrative records. The primary outcome was the rate of patients who left without being treated (LWBT), and the secondary outcome was total ED boarding time for admitted patients. A multivariable robust linear regression model was used to determine whether ED expansion was associated with the outcome measures.The mean (±SD) daily adult volume was 128 (±14) patients before expansion and 145 (±17) patients after. The percentage of patients who LWBT was unchanged: 9.0% before expansion versus 8.3% after expansion (difference = 0.6%, 95% confidence interval [CI] = -0.16% to 1.4%). Total ED boarding time increased from 160 to 180 hours/day (difference = 20 hours, 95% CI = 8 to 32 hours). After daily ED volume, low-acuity area volume, daily wait time, daily boarding hours, and nurse staffing were adjusted for, the percentage of patients who LWBT was not independently associated with ED expansion (p = 0.053). After ED admissions, ED intensive care unit (ICU) admissions, elective surgical admissions, hospital occupancy rate, ICU occupancy rate, and number of operational ICU beds were adjusted for, the increase in ED boarding hours was independently associated with the ED expansion (p = 0.005).An increase in ED bed capacity was associated with no significant change in the percentage of patients who LWBT, but had an unintended consequence of an increase in ED boarding hours. ED expansion alone does not appear to be an adequate solution to ED crowding.

Project description:BACKGROUND:Guidelines recommend endotracheal intubation in trauma patients with a Glasgow coma scale (GCS) < 9 because of the loss of airway reflexes and consequential risk of airway obstruction. However, in patients with acute alcohol intoxication guidelines are not clear. Thus, we aimed to determine the proportional incidence of intubation in alcohol intoxication and compare the clinical characteristics of intubated and non-intubated patients, as well as reasons for intubation in all patients and in the subgroup of patients with reduced GCS (< 9) but without traumatic brain injury. METHODS:We performed a retrospective analysis of all consultations to an urban ED in Switzerland that presented with an acute alcohol intoxication between 1st June 2012 and 31th Mai 2017. Patient and emergency consultations' characteristics, related injuries, intubation and reason for intubations were extracted. As a subgroup analysis, we analysed the patients with a GCS < 9 without a traumatic brain injury. RESULTS:Of 3003 consultations included from 01.06.2012 to 31.05.2017, 68 were intubated, leading to a proportional incidence of 2.3% intubations in alcohol-intoxication. Intubated patients had a lower blood alcohol concentration (1.3 g/kg [IQR 1.0-2.2] vs. 1.6 g/kg [IQR1.1-2.2], p = 0.034) and less often suffered from chronic alcohol abuse (1183 [39.4%] patients vs. 14 [20.6%], p = 0.001) than non-intubated patients. Patients with trauma were intubated more often (33 patients [48.5%] vs. 742 [25.3%], p < 0.001). In subgroup analysis, 110/145 patients (74.3%) were not intubated; again, more intubated patients had a history of trauma (9 patients [25.7%] vs. 10 [9.1%], p = 0.011). CONCLUSIONS:Intubation in alcohol-intoxicated patients is rare and, among intoxicated patients with GCS < 9, more than two thirds were not intubated in our study - without severe complications. Trauma in general, independent of the history of a traumatic brain injury, and a missing history of chronic alcohol abuse are associated with intubation, but not with blood alcohol concentration. Special caution is required for intoxicated patients with trauma or other additional intoxications or diseases.

Project description:IntroductionApnoeic oxygenation using nasal high-flow oxygen delivery systems with heated and humidified oxygen has recently gained popularity in the anaesthesia community. It has been shown to allow a prolonged apnoea time of up to 65 min as CO2 increase was far slower compared with previously reported data from CO2 increase during apnoea. A ventilatory exchange due to the high nasal oxygen flow was proposed explaining that phenomenon. However, recent studies in children did not show any difference in CO2 clearance comparing high-flow with low-flow oxygen. To investigate this ventilatory exchange in adults, we plan this study comparing different oxygen flow rates and the increase of CO2 during apnoea. We hypothesise that CO2 clearance is non-inferior when applying low oxygen flow rates.Methods and analysisIn this single-centre, single-blinded, randomised controlled trial, we randomly assign 100 patients planned for elective surgery to either control (oxygen 70 L/min, airway opened by laryngoscopy) or one of three intervention groups: oxygen 70, or 10, or 2 L/min, all with jaw thrust to secure airway patency. After anaesthesia induction and neuromuscular blockage, either one of the interventions or the control will be applied according to randomisation. Throughout the apnoea period, we will measure the increase of transcutaneous pCO2 (tcpCO2) until any one of the following criteria is met: time=15 min, SpO2 <92%, tcpCO2 >10.67 kPa, art. pH <7.1, K+ >6.0 mmol/L. Primary outcome is the mean tcpCO2 increase in kPa/min.Ethics and disseminationAfter Cantonal Ethic Committee of Bern approval (ID 2018-00293, 22.03.2018), all study participants will provide written informed consent. Patients vulnerable towards hypoxia or hypercarbia are excluded. Study results will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration numberThis study was registered on www.clinicaltrials.gov (NCT03478774,Pre-results) and the Swiss Trial Registry KOFAM (SNCTP000002861).

Project description:INTRODUCTION:Hypoxaemia is a major complication during gastrointestinal endoscopy (GIE) procedures (upper/lower) when performed under deep sedation in the procedure room. Standard oxygen therapy (SOT) is used to prevent hypoxaemia. Data suggest that risk factors for hypoxaemia under deep sedation during GIE are obstructive sleep apnoea syndrome, a body mass index above 30?kg/m², high blood pressure, diabetes, heart disease, age over 60 years old, high American Society of Anesthesiologists physical status class and the association of upper and lower GIE. High-flow nasal oxygenation (HFNO) may potentially improve oxygenation during GIE under deep sedation. We hypothesised that HFNO could decrease the incidence of hypoxaemia in comparison with SOT. METHODS AND ANALYSIS:The ODEPHI (High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled) study is a multicentre randomised controlled trial comparing HFNO to SOT during GIE (upper and/or lower) under deep sedation administered by anaesthesiologists in the procedure room. Three hundred and eighty patients will be randomised with a 1:1 ratio in two parallel groups.The primary outcome is the occurrence of hypoxaemia, defined by a pulse oximetry measurement of peripheral capillary oxygen saturation (SpO2) below or equal to 92% during the GIE procedure. Secondary outcomes include prolonged hypoxaemia, severe hypoxaemia, need for manoeuvres to maintain upper airway patency and other adverse events. ETHICS AND DISSEMINATION:This study has been approved by the ethics committee (CPP Sud Est Paris V, France), and patients are included after informed consent. The results will be submitted for publication in peer-reviewed journals. As provided for by French law, patients participating in the study are informed that they have the possibility to ask the investigators, once the study is completed, to be informed of the overall results of the study. Thus, a summary of the results will be sent by post to the participants on request. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Registry (NCT03829293).

Project description:IntroductionTracheal intubation in the intensive care unit (ICU) is associated with severe life-threatening complications including severe hypoxaemia. Preoxygenation before intubation has been recommended in order to decrease such complications. Non-invasive ventilation (NIV)-assisted preoxygenation allows increased oxygen saturation during the intubation procedure, by applying a positive end-expiratory pressure (PEEP) to prevent alveolar derecruitment. However, the NIV mask has to be taken off after preoxygenation to allow the passage of the tube through the mouth. The patient with hypoxaemia does not receive oxygen during this period, at risk of major hypoxaemia. High-flow nasal cannula oxygen therapy (HFNC) has a potential for apnoeic oxygenation during the apnoea period following the preoxygenation with NIV. Whether application of HFNC combined with NIV is more effective at reducing oxygen desaturation during the intubation procedure compared with NIV alone for preoxygenation in patients with hypoxaemia in the ICU with acute respiratory failure remains to be established.Methods and analysisThe HFNC combined to NIV for decreasing oxygen desaturation during the intubation procedure in patients with hypoxaemia in the ICU (OPTINIV) trial is an investigator-initiated monocentre randomised controlled two-arm trial with assessor-blinded outcome assessment. The OPTINIV trial randomises 50 patients with hypoxaemia requiring orotracheal intubation for acute respiratory failure to receive NIV (pressure support=10, PEEP=5, fractional inspired oxygen (FiO2)=100%) combined with HFNC (flow=60 L/min, FiO2=100%, interventional group) or NIV alone (reference group) for preoxygenation. The primary outcome is lowest oxygen saturation during the intubation procedure. Secondary outcomes are intubation-related complications, quality of preoxygenation and ICU mortality.Ethics and disseminationThe study project has been approved by the appropriate ethics committee (CPP Sud-Méditerranée). Informed consent is required. If combined application of HFNC and NIV for preoxygenation of patients with hypoxaemia in the ICU proves superior to NIV preoxygenation, its use will become standard practice, thereby decreasing hypoxaemia during the intubation procedure and potential complications related to intubation.Trial registration numberNCT02530957.

Dataset Information

Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial.

Publications

Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial.

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