Study Results
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Basic Information
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TERMINATED
42 participants
OBSERVATIONAL
2020-10-01
2022-07-01
Brief Summary
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Detailed Description
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This study is designed to investigate the hypothesis that sedation by use of sevoflurane leads to better oxygenation in COVID-19 patients, compared to intravenous sedatives.
Secondarily, the effects of sevoflurane compared to intravenous sedatives on duration of admission and mechanical ventilation, on respiratory parameters and hemodynamics, inflammatory parameters, use of opioids, manner of waking up and prevalence of delirium, will be investigated.
Study design: The study concerns a single center cohort study in the ICU of the Jeroen Bosch Hospital in The Netherlands. Inhaled anesthesia by sevoflurane is compared to intravenous sedation. Both are considered to be standard of care.
Study population: Patients with respiratory insufficiency due to COVID-19 pneumonia, with need for invasive mechanical ventilation on the ICU in the Jeroen Bosch Hospital.
Study parameters: Primary outcome is P/F ratio (arterial oxygen tension/fraction of inspired oxygen; PaO2/FiO2 ratio) on day 2 and day 5. Secondary outcomes are duration of ICU admission, number of ventilator-free days after 28 days (28VFD), inflammation parameters (CRP/PCT), quality of waking up, number of delirium free days after 28 days (28DFD) and need for vasopressors. Also patient characteristics like demographic information (age, sex, BMI, comorbidity), respiratory and hemodynamic values and use of other sedatives will be evaluated.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sevoflurane
patients admitted because of respiratory insufficiency due to COVID-19 with need for invasive mechanical ventilation that are sedated by using sevoflurane
Sevoflurane
sevoflurane inhalation
Control
patients admitted because of respiratory insufficiency due to COVID-19 with need for invasive mechanical ventilation that are sedated by means of intravenous medication, such as propofol, midazolam, esketamine of fentanyl
No interventions assigned to this group
Interventions
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Sevoflurane
sevoflurane inhalation
Eligibility Criteria
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Inclusion Criteria
* More than 24 hours of invasive mechanical ventilation needed
* Positive test (e.g. Polymerase Chain Reaction (PCR)) for SARS-CoV-2
Exclusion Criteria
* known allergy or hypersensitivity for halogenated anesthetics
* known or suspected predisposition for malignant hyperthermia
* suspected or proven intracranial hypertension
* severe liver dysfunction and/or icterus (serum bilirubin \>42,8-51,3 μg per liter)
* neutropenia (\<0.5X10\^9 neutrophils per liter)
* chemotherapy in the month prior to ICU admission
* patients that are transported to other hospitals during admission
18 Years
ALL
No
Sponsors
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Jeroen Bosch Ziekenhuis
OTHER
Responsible Party
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K.S. Simons
MD, PhD
Principal Investigators
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D. van Nieuwenhuizen, RN
Role: PRINCIPAL_INVESTIGATOR
Jeroen Bosch Hospital
Locations
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
Countries
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References
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Banks WA, Kastin AJ, Gutierrez EG. Penetration of interleukin-6 across the murine blood-brain barrier. Neurosci Lett. 1994 Sep 26;179(1-2):53-6. doi: 10.1016/0304-3940(94)90933-4.
Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, LeGall JR, Morris A, Spragg R. Report of the American-European consensus conference on ARDS: definitions, mechanisms, relevant outcomes and clinical trial coordination. The Consensus Committee. Intensive Care Med. 1994;20(3):225-32. doi: 10.1007/BF01704707.
Bisbal M, Arnal JM, Passelac A, Sallee M, Demory D, Donati SY, Granier I, Corno G, Durand-Gasselin J. [Efficacy, safety and cost of sedation with sevoflurane in intensive care unit]. Ann Fr Anesth Reanim. 2011 Apr;30(4):335-41. doi: 10.1016/j.annfar.2011.01.019. Epub 2011 Mar 15. French.
Burki T. The origin of SARS-CoV-2. Lancet Infect Dis. 2020 Sep;20(9):1018-1019. doi: 10.1016/S1473-3099(20)30641-1. No abstract available.
Ferrando C, Aguilar G, Piqueras L, Soro M, Moreno J, Belda FJ. Sevoflurane, but not propofol, reduces the lung inflammatory response and improves oxygenation in an acute respiratory distress syndrome model: a randomised laboratory study. Eur J Anaesthesiol. 2013 Aug;30(8):455-63. doi: 10.1097/EJA.0b013e32835f0aa5.
Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.
Grifoni E, Valoriani A, Cei F, Lamanna R, Gelli AMG, Ciambotti B, Vannucchi V, Moroni F, Pelagatti L, Tarquini R, Landini G, Vanni S, Masotti L. Interleukin-6 as prognosticator in patients with COVID-19. J Infect. 2020 Sep;81(3):452-482. doi: 10.1016/j.jinf.2020.06.008. Epub 2020 Jun 8. No abstract available.
Jabaudon M, Boucher P, Imhoff E, Chabanne R, Faure JS, Roszyk L, Thibault S, Blondonnet R, Clairefond G, Guerin R, Perbet S, Cayot S, Godet T, Pereira B, Sapin V, Bazin JE, Futier E, Constantin JM. Sevoflurane for Sedation in Acute Respiratory Distress Syndrome. A Randomized Controlled Pilot Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):792-800. doi: 10.1164/rccm.201604-0686OC.
Jerath A, Ferguson ND, Cuthbertson B. Inhalational volatile-based sedation for COVID-19 pneumonia and ARDS. Intensive Care Med. 2020 Aug;46(8):1563-1566. doi: 10.1007/s00134-020-06154-8. Epub 2020 Jun 25.
Jerath A, Parotto M, Wasowicz M, Ferguson ND. Volatile Anesthetics. Is a New Player Emerging in Critical Care Sedation? Am J Respir Crit Care Med. 2016 Jun 1;193(11):1202-12. doi: 10.1164/rccm.201512-2435CP.
Kellner P, Muller M, Piegeler T, Eugster P, Booy C, Schlapfer M, Beck-Schimmer B. Sevoflurane Abolishes Oxygenation Impairment in a Long-Term Rat Model of Acute Lung Injury. Anesth Analg. 2017 Jan;124(1):194-203. doi: 10.1213/ANE.0000000000001530.
Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S. Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med. 2011 Jun;37(6):933-41. doi: 10.1007/s00134-011-2187-3. Epub 2011 Mar 29.
O'Gara B, Talmor D. Lung protective properties of the volatile anesthetics. Intensive Care Med. 2016 Sep;42(9):1487-9. doi: 10.1007/s00134-016-4429-x. Epub 2016 Jul 4. No abstract available.
Perbet S, Bourdeaux D, Sautou V, Pereira B, Chabanne R, Constantin JM, Chopineau J, Bazin JE. A pharmacokinetic study of 48-hour sevoflurane inhalation using a disposable delivery system (AnaConDa(R)) in ICU patients. Minerva Anestesiol. 2014 Jun;80(6):655-65. Epub 2013 Nov 13.
Soukup J, Selle A, Wienke A, Steighardt J, Wagner NM, Kellner P. Efficiency and safety of inhalative sedation with sevoflurane in comparison to an intravenous sedation concept with propofol in intensive care patients: study protocol for a randomized controlled trial. Trials. 2012 Aug 10;13:135. doi: 10.1186/1745-6215-13-135.
Strosing KM, Faller S, Gyllenram V, Engelstaedter H, Buerkle H, Spassov S, Hoetzel A. Inhaled Anesthetics Exert Different Protective Properties in a Mouse Model of Ventilator-Induced Lung Injury. Anesth Analg. 2016 Jul;123(1):143-51. doi: 10.1213/ANE.0000000000001296.
Ware LB, Matthay MA. Alveolar fluid clearance is impaired in the majority of patients with acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 May;163(6):1376-83. doi: 10.1164/ajrccm.163.6.2004035.
Other Identifiers
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2020.10.15.03
Identifier Type: -
Identifier Source: org_study_id
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