Mechanical Ventilation Bronchodilators
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Assessment Report COVID-19 Vaccine Astrazeneca EMA/94907/2021
29 January 2021 EMA/94907/2021 Committee for Medicinal Products for Human Use (CHMP) Assessment report COVID-19 Vaccine AstraZeneca Common name: COVID-19 Vaccine (ChAdOx1-S [recombinant]) Procedure No. EMEA/H/C/005675/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ..................................................................................... 7 1.2. Steps taken for the assessment of the product ........................................................ 9 2. Scientific discussion .............................................................................. 12 2.1. Problem statement ............................................................................................. 12 2.1.1. Disease or condition ........................................................................................ 12 2.1.2. Epidemiology and risk factors ........................................................................... 12 2.1.3. Aetiology and pathogenesis ............................................................................. -
Acid-Base Abnormalities in Dogs with Diabetic Ketoacidosis: a Prospective Study of 60 Cases
325 Acid-base abnormalities in dogs with diabetic ketoacidosis: a prospective study of 60 cases Distúrbios ácido-base em cães com cetoacidose diabética: estudo prospectivo de 60 casos Ricardo DUARTE1; Denise Maria Nunes SIMÕES1; Khadine Kazue KANAYAMA1; Márcia Mery KOGIKA1 1School of Veterinary Medicine and Animal Science, University of São Paulo, São Paulo-SP, Brazil Abstract Diabetic ketoacidosis (DKA) is considered a typical high anion gap metabolic acidosis due to the retention of ketoanions. The objective of this study was to describe the acid-base disturbances of dogs with DKA and further characterize them, according to their frequency, adequacy of the secondary physiologic response, and occurrence of mixed disturbances. Sixty dogs with DKA were enrolled in the study. Arterial blood pH and gas tensions, plasma electrolytes, serum b-hydroxybutyrate (b-OHB), glucose, albumin and urea concentrations were determined for all dogs included in the study. All dogs were evaluated individually and systematically by the traditional approach to the diagnosis of acid- base disorders. Most of the dogs had a high anion gap acidosis, with appropriated respiratory response (n = 18; 30%) or concurrent respiratory alkalosis (n = 14; 23%). Hyperchloremic acidosis with moderated to marked increases in b-OHB was observed in 18 dogs (30%) and 7 of these patients had concurrent respiratory alkalosis. Hyperchloremic acidosis with mild increase in b-OHB was observed in 6 dogs (10%). Four dogs (7%) had a high anion gap acidosis with mild increase in b-OHB and respiratory alkalosis. Most of dogs with DKA had a high anion gap acidosis, but mixed acid-base disorders were common, chiefly high anion gap acidosis and concurrent respiratory alkalosis, and hyperchloremic acidosis with moderated to marked increases in serum b-OHB. -
Pathophysiology of Acid Base Balance: the Theory Practice Relationship
Intensive and Critical Care Nursing (2008) 24, 28—40 ORIGINAL ARTICLE Pathophysiology of acid base balance: The theory practice relationship Sharon L. Edwards ∗ Buckinghamshire Chilterns University College, Chalfont Campus, Newland Park, Gorelands Lane, Chalfont St. Giles, Buckinghamshire HP8 4AD, United Kingdom Accepted 13 May 2007 KEYWORDS Summary There are many disorders/diseases that lead to changes in acid base Acid base balance; balance. These conditions are not rare or uncommon in clinical practice, but every- Arterial blood gases; day occurrences on the ward or in critical care. Conditions such as asthma, chronic Acidosis; obstructive pulmonary disease (bronchitis or emphasaemia), diabetic ketoacidosis, Alkalosis renal disease or failure, any type of shock (sepsis, anaphylaxsis, neurogenic, cardio- genic, hypovolaemia), stress or anxiety which can lead to hyperventilation, and some drugs (sedatives, opoids) leading to reduced ventilation. In addition, some symptoms of disease can cause vomiting and diarrhoea, which effects acid base balance. It is imperative that critical care nurses are aware of changes that occur in relation to altered physiology, leading to an understanding of the changes in patients’ condition that are observed, and why the administration of some immediate therapies such as oxygen is imperative. © 2007 Elsevier Ltd. All rights reserved. Introduction the essential concepts of acid base physiology is necessary so that quick and correct diagnosis can The implications for practice with regards to be determined and appropriate treatment imple- acid base physiology are separated into respi- mented. ratory acidosis and alkalosis, metabolic acidosis The homeostatic imbalances of acid base are and alkalosis, observed in patients with differing examined as the body attempts to maintain pH bal- aetiologies. -
Evaluation and Treatment of Alkalosis in Children
Review Article 51 Evaluation and Treatment of Alkalosis in Children Matjaž Kopač1 1 Division of Pediatrics, Department of Nephrology, University Address for correspondence Matjaž Kopač, MD, DSc, Division of Medical Centre Ljubljana, Ljubljana, Slovenia Pediatrics, Department of Nephrology, University Medical Centre Ljubljana, Bohoričeva 20, 1000 Ljubljana, Slovenia J Pediatr Intensive Care 2019;8:51–56. (e-mail: [email protected]). Abstract Alkalosisisadisorderofacid–base balance defined by elevated pH of the arterial blood. Metabolic alkalosis is characterized by primary elevation of the serum bicarbonate. Due to several mechanisms, it is often associated with hypochloremia and hypokalemia and can only persist in the presence of factors causing and maintaining alkalosis. Keywords Respiratory alkalosis is a consequence of dysfunction of respiratory system’s control ► alkalosis center. There are no pathognomonic symptoms. History is important in the evaluation ► children of alkalosis and usually reveals the cause. It is important to evaluate volemia during ► chloride physical examination. Treatment must be causal and prognosis depends on a cause. Introduction hydrogen ion concentration and an alkalosis is a pathologic Alkalosis is a disorder of acid–base balance defined by process that causes a decrease in the hydrogen ion concentra- elevated pH of the arterial blood. According to the origin, it tion. Therefore, acidemia and alkalemia indicate the pH can be metabolic or respiratory. Metabolic alkalosis is char- abnormality while acidosis and alkalosis indicate the patho- acterized by primary elevation of the serum bicarbonate that logic process that is taking place.3 can result from several mechanisms. It is the most common Regulation of hydrogen ion balance is basically similar to form of acid–base balance disorders. -
Ventilation Recommendations Table
SURVIVING SEPSIS CAMPAIGN INTERNATIONAL GUIDELINES FOR THE MANAGEMENT OF SEPTIC SHOCK AND SEPSIS-ASSOCIATED ORGAN DYSFUNCTION IN CHILDREN VENTILATION RECOMMENDATIONS TABLE RECOMMENDATION #34 STRENGTH & QUALITY OF EVIDENCE We were unable to issue a recommendation about whether to Insufficient intubate children with fluid-refractory, catecholamine-resistant septic shock. However, in our practice, we commonly intubate children with fluid-refractory, catecholamine-resistant septic shock without respiratory failure. RECOMMENDATION #35 STRENGTH & QUALITY OF EVIDENCE We suggest not to use etomidate when intubating children • Weak with septic shock or other sepsis-associated organ dysfunction. • Low-Quality of Evidence RECOMMENDATION #36 STRENGTH & QUALITY OF EVIDENCE We suggest a trial of noninvasive mechanical ventilation (over • Weak invasive mechanical ventilation) in children with sepsis-induced • Very Low-Quality of pediatric ARDS (PARDS) without a clear indication for intubation Evidence and who are responding to initial resuscitation. © 2020 Society of Critical Care Medicine and European Society of Intensive Care Medicine Care Medicine. RECOMMENDATION #37 STRENGTH & QUALITY OF EVIDENCE We suggest using high positive end-expiratory pressure (PEEP) • Weak in children with sepsis-induced PARDS. Remarks: The exact level • Very Low-Quality of of high PEEP has not been tested or determined in PARDS Evidence patients. Some RCTs and observational studies in PARDS have used and advocated for use of the ARDS-network PEEP to Fio2 grid though adverse hemodynamic effects of high PEEP may be more prominent in children with septic shock. RECOMMENDATION #38 STRENGTH & QUALITY OF EVIDENCE We cannot suggest for or against the use of recruitment Insufficient maneuvers in children with sepsis-induced PARDS and refractory hypoxemia. -
TITLE: Acid-Base Disorders PRESENTER: Brenda Suh-Lailam
TITLE: Acid-Base Disorders PRESENTER: Brenda Suh-Lailam Slide 1: Hello, my name is Brenda Suh-Lailam. I am an Assistant Director of Clinical Chemistry and Mass Spectrometry at Ann & Robert H. Lurie Children’s Hospital of Chicago, and an Assistant Professor of Pathology at Northwestern Feinberg School of Medicine. Welcome to this Pearl of Laboratory Medicine on “Acid-Base Disorders.” Slide 2: During metabolism, the body produces hydrogen ions which affect metabolic processes if concentration is not regulated. To maintain pH within physiologic limits, there are several buffer systems that help regulate hydrogen ion concentration. For example, bicarbonate, plasma proteins, and hemoglobin buffer systems. The bicarbonate buffer system is the major buffer system in the blood. Slide 3: In the bicarbonate buffer system, bicarbonate, which is the metabolic component, is controlled by the kidneys. Carbon dioxide is the respiratory component and is controlled by the lungs. Changes in the respiratory and metabolic components, as depicted here, can lead to a decrease in pH termed acidosis, or an increase in pH termed alkalosis. Slide 4: Because the bicarbonate buffer system is the major buffer system of blood, estimation of pH using the Henderson-Hasselbalch equation is usually performed, expressed as a ratio of bicarbonate and carbon dioxide. Where pKa is the pH at which the concentration of protonated and unprotonated species are equal, and 0.0307 is the solubility coefficient of carbon dioxide. Four variables are present in this equation; knowing three variables allows for calculation of the fourth. Since pKa is a constant, and pH and carbon dioxide are measured during blood gas analysis, bicarbonate can, therefore, be determined using this equation. -
Package Insert Template for Oral Rehydration Salt (Ors)
PACKAGE INSERT TEMPLATE FOR ORAL REHYDRATION SALT (ORS) Brand or Product Name [Product name] Powder for Oral Solution [Product name] Liquid in the form of solution/suspension Name and Strength of Active Substance(s) Sodium chloride ………………(12.683% w/v) Glucose, anhydrous…………...(65.854% w/v) Potassium chloride………...…...(7.317% w/v) Trisodium citrate, dihydrate ….(14.146% w/v) Product Description [Visual description of the appearance of the product (eg colour etc)] Eg:A white to off-white colour granules, when dissolved in water, forms an orange colour solution. Pharmacodynamics The reconstituted solution contains a mixture of sodium and potassium salts along with glucose, which facilitates the absorption of sodium and potassium from the intestine. Water is drawn from the bowel by the osmotic effect. As well as “drying up” the stools, the dehydration and loss of electrolytes caused by the diarrhoea is corrected by the water and electrolytes absorbed. Pharmacokinetics Glucose After oral administration glucose is completely absorbed by a sodium dependent uptake mechanism exhibiting saturation kinetics. Blood levels return to normal within two hours of ingestion. Potassium Chloride No specific control mechanisms limit absorption of potassium, which is usually complete. Potassium is excreted largely by the kidneys, though 10% is excreted by the colonic mucosa. Potassium excretion is reduced in patients with renal impairment and in the elderly, so extreme caution should be used in treating such patients with potassium salts. Sodium Bicarbonate Kinetics are determined by the physiological state of the patient at the time. Sodium Chloride Readily absorbed from the gastrointestinal tract. Gut absorption, particularly in the jejunum is enhanced by the addition of glucose. -
Acid-Base Physiology & Anesthesia
ACID-BASE PHYSIOLOGY & ANESTHESIA Lyon Lee DVM PhD DACVA Introductions • Abnormal acid-base changes are a result of a disease process. They are not the disease. • Abnormal acid base disorder predicts the outcome of the case but often is not a direct cause of the mortality, but rather is an epiphenomenon. • Disorders of acid base balance result from disorders of primary regulating organs (lungs or kidneys etc), exogenous drugs or fluids that change the ability to maintain normal acid base balance. • An acid is a hydrogen ion or proton donor, and a substance which causes a rise in H+ concentration on being added to water. • A base is a hydrogen ion or proton acceptor, and a substance which causes a rise in OH- concentration when added to water. • Strength of acids or bases refers to their ability to donate and accept H+ ions respectively. • When hydrochloric acid is dissolved in water all or almost all of the H in the acid is released as H+. • When lactic acid is dissolved in water a considerable quantity remains as lactic acid molecules. • Lactic acid is, therefore, said to be a weaker acid than hydrochloric acid, but the lactate ion possess a stronger conjugate base than hydrochlorate. • The stronger the acid, the weaker its conjugate base, that is, the less ability of the base to accept H+, therefore termed, ‘strong acid’ • Carbonic acid ionizes less than lactic acid and so is weaker than lactic acid, therefore termed, ‘weak acid’. • Thus lactic acid might be referred to as weak when considered in relation to hydrochloric acid but strong when compared to carbonic acid. -
Tracheotomy in Ventilated Patients with COVID19
Tracheotomy in ventilated patients with COVID-19 Guidelines from the COVID-19 Tracheotomy Task Force, a Working Group of the Airway Safety Committee of the University of Pennsylvania Health System Tiffany N. Chao, MD1; Benjamin M. Braslow, MD2; Niels D. Martin, MD2; Ara A. Chalian, MD1; Joshua H. Atkins, MD PhD3; Andrew R. Haas, MD PhD4; Christopher H. Rassekh, MD1 1. Department of Otorhinolaryngology – Head and Neck Surgery, University of Pennsylvania, Philadelphia 2. Department of Surgery, University of Pennsylvania, Philadelphia 3. Department of Anesthesiology, University of Pennsylvania, Philadelphia 4. Division of Pulmonary, Allergy, and Critical Care, University of Pennsylvania, Philadelphia Background The novel coronavirus (COVID-19) global pandemic is characterized by rapid respiratory decompensation and subsequent need for endotracheal intubation and mechanical ventilation in severe cases1,2. Approximately 3-17% of hospitalized patients require invasive mechanical ventilation3-6. Current recommendations advocate for early intubation, with many also advocating the avoidance of non-invasive positive pressure ventilation such as high-flow nasal cannula, BiPAP, and bag-masking as they increase the risk of transmission through generation of aerosols7-9. Purpose Here we seek to determine whether there is a subset of ventilated COVID-19 patients for which tracheotomy may be indicated, while considering patient prognosis and the risks of transmission. Recommendations may not be appropriate for every institution and may change as the current situation evolves. The goal of these guidelines is to highlight specific considerations for patients with COVID-19 on an individual and population level. Any airway procedure increases the risk of exposure and transmission from patient to provider. -
Mechanical Ventilation Page 1 of 5
UTMB RESPIRATORY CARE SERVICES Policy 7.3.53 PROCEDURE - Mechanical Ventilation Page 1 of 5 Mechanical Ventilation Effective: 10/26/95 Formulated: 11/78 Revised: 04/11/18 Mechanical Ventilation Purpose Mechanical Artificial Ventilation refers to any methods to deliver volumes of gas into a patient's lungs over an extended period of time to remove metabolically produced carbon dioxide. It is used to provide the pulmonary system with the mechanical power to maintain physiologic ventilation, to manipulate the ventilatory pattern and airway pressures for purposes of improving the efficiency of ventilation and/or oxygenation, and to decrease myocardial work by decreasing the work of breathing. Scope Outlines the procedure of instituting mechanical ventilation and monitoring. Accountability • Mechanical Ventilation may be instituted by a qualified licensed Respirator Care Practitioner (RCP). • To be qualified the practitioner must complete a competency based check off on the ventilator to be used. • The RCP will have an understanding of the age specific requirements of the patient. Physician's Initial orders for therapy must include a mode (i.e. mandatory Order Ventilation/Assist/Control, pressure control etc., a Rate, a Tidal Volume, and an Oxygen concentration and should include a desired level of Positive End Expiratory Pressure, and Pressure Support if applicable. Pressure modes will include inspiratory time and level of pressure control. In the absence of a complete follow up order reflecting new ventilator changes, the original ventilator settings will be maintained in compliance with last order until physician is contacted and the order is clarified. Indications Mechanical Ventilation is generally indicated in cases of acute alveolar hypoventilation due to any cause, acute respiratory failure due to any cause, and as a prophylactic post-op in certain patients. -
Mechanical Ventilation
Fundamentals of MMeecchhaanniiccaall VVeennttiillaattiioonn A short course on the theory and application of mechanical ventilators Robert L. Chatburn, BS, RRT-NPS, FAARC Director Respiratory Care Department University Hospitals of Cleveland Associate Professor Department of Pediatrics Case Western Reserve University Cleveland, Ohio Mandu Press Ltd. Cleveland Heights, Ohio Published by: Mandu Press Ltd. PO Box 18284 Cleveland Heights, OH 44118-0284 All rights reserved. This book, or any parts thereof, may not be used or reproduced by any means, electronic or mechanical, including photocopying, recording or by any information storage and retrieval system, without written permission from the publisher, except for the inclusion of brief quotations in a review. First Edition Copyright 2003 by Robert L. Chatburn Library of Congress Control Number: 2003103281 ISBN, printed edition: 0-9729438-2-X ISBN, PDF edition: 0-9729438-3-8 First printing: 2003 Care has been taken to confirm the accuracy of the information presented and to describe generally accepted practices. However, the author and publisher are not responsible for errors or omissions or for any consequences from application of the information in this book and make no warranty, express or implied, with respect to the contents of the publication. Table of Contents 1. INTRODUCTION TO VENTILATION..............................1 Self Assessment Questions.......................................................... 4 Definitions................................................................................ -
A Case-Based Approach to Acid-Base Disorders
A Case-Based Approach to Acid-Base Disorders Justin Muir, PharmD Clinical Pharmacy Manager, Medical ICU NewYork-Presbyterian Hospital Columbia University Irving Medical Center [email protected] Disclosures None Objectives At the completion of this activity, pharmacists will be able to: 1. Describe acid-base physiology and disease states that lead to acid-base disorders. 2. Demonstrate a step-wise approach to interpretation of acid-base disorders and compensatory states. 3. Analyze contemporary literature regarding the use of sodium bicarbonate in metabolic acidosis. At the completion of this activity, pharmacy technicians will be able to: 1. Explain the importance of acid-base balance. 2. List the acid-base disorders seen in clinical practice. 3. Identify potential therapies used to treat acid-base disorders. Case A 51 year old man with history of erosive esophagitis, diabetes mellitus, chronic pancreatitis, and bipolar disorder is admitted with several days of severe nausea, vomiting, and abdominal pain. 135 87 31 pH 7.46 / pCO 29 / pO 81 861 2 2 BE -3.8 / HCO - 18 / SaO 96 5.6 20 0.9 3 2 • What additional data should be obtained? • What acid base disturbance(s) is/are present? Introduction • Acid base status is tightly regulated to maintain normal biochemical reactions and organ function • Body uses multiple mechanisms to maintain homeostasis • Abnormalities are extremely common in hospitalized patients with a higher incidence in critically ill with more complex pictures • A standard approach to analysis can help guide diagnosis and treatment Important acid-base determinants Blood gas generally includes at least: Normal range Measurement Description (arterial blood) pH -log [H+] 7.35-7.45 pCO2 partial pressure of dissolved CO2 35-45 mmHg pO2 partial pressure of dissolved O2 80-100 mmHg Base excess calculated measure of metabolic acid/base deviation from normal -3 to +3 SO2 calculated measure of Hgb O2 saturation based on pO2 95-100% - HCO3 calculated measure based on relationship of pH and pCO2 22-26 mEq/L Haber RJ.