Clinical and Functional Outcomes of Critically Ill Patients With COVID-19
NCT ID: NCT05024500
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2020-10-21
2022-12-30
Brief Summary
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Detailed Description
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Objective: To compare the clinical and laboratory evolution and the respiratory and peripheral muscle functions in mechanically ventilated patients with COVID-19 submitted to PEEP titration by the following methods: ARDSNet protocol, driving pressure (DP) and electrical impedance tomography (EIT), as well as following them up after hospital discharge.
Methods: This is a controlled, randomized, double blind clinical trial with 90 mechanically ventilated patients to be randomized in one of the 3 PEEP titration- related groups: ARDSNet protocol, Driving Pressure-DP (electing PEEP level by the lowest DP) and by the EIT (PEEP selected will be the closest level above the intercept point of cumulated collapse and overdistension percentage curves). Clinical, laboratory, oxygenation, ventilation, respiratory and regional mechanics data, as well as peripheral muscle outcomes (strength and functionality) will be monitored from intubation to extubation in the supine and prone position. The outcomes of respiratory and peripheral muscles functionality will be monitored for six months after hospital discharge. All ethical principles will be respected with either written Free and Consent Term by the patient or relatives at the intensive care phase or at the post ICU discharge phase. Data will be registered for posterior analysis, which considers the difference between groups with p \<0.05.
Expected results: Based on this study, it is expected to identify the Peep titration method associated to the greater beneficial and less deleterious effects in critically ill patients on MV. Also to address appropriate lung protective ventilation strategy for these patients and to detect respiratory and peripheral muscle disorders as early as possible in critically ill survivors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ADRSNet protocol
ARDSnet protocol is the current, standard of care for ARDS. Its used by setting PEEP and the fraction of inspired oxygen (FiO2) to achieve the oxygenation goal (SpO2 ≥ 93% - accepting the range of 90-96%)
ARDSNet table
The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation.
Driving Pressure (DP)
setting PEEP after performing a modified alveolar recruitment maneuver followed by a decremental PEEP titration electing the level correspondent to the lowest driving pressure.
Driving Pressure
The setting of the lowest PEEP level by the lowest correspondent driving pressure, which is defined by the difference of plateau pressure, after a modified alveolar recruitment maneuver.
Electrical Impedance Tomography (EIT)
After performing a modified alveolar recruitment maneuver, the PEEP decremental titration guided by the EIT will be set at the level above the intersection of the curves representing relative alveolar overdistention and collapse.
Electrical Impedance Tomography
The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver.
Interventions
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ARDSNet table
The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation.
Driving Pressure
The setting of the lowest PEEP level by the lowest correspondent driving pressure, which is defined by the difference of plateau pressure, after a modified alveolar recruitment maneuver.
Electrical Impedance Tomography
The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Universidade Federal de Pernambuco
OTHER
Coordination for the Improvement of Higher Education Personnel
OTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Fundação de Amparo à Ciência e Tecnologia de Pernambuco
OTHER
University of Pernambuco
OTHER
Responsible Party
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Shirley Lima Campos
Associate Professor
Principal Investigators
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Shirley Lima Campos, PhD
Role: STUDY_DIRECTOR
Universidade Federal de Pernambuco
Locations
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Hospital das Clinicas - UFPE
Recife, Pernambuco, Brazil
Physical Therapy Department, Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
Hospital da Mulher do Recife
Recife, Pernambuco, Brazil
Hospital Geral Otavio de Freitas
Recife, Pernambuco, Brazil
Countries
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References
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Adhikari SP, Meng S, Wu YJ, Mao YP, Ye RX, Wang QZ, Sun C, Sylvia S, Rozelle S, Raat H, Zhou H. Epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the early outbreak period: a scoping review. Infect Dis Poverty. 2020 Mar 17;9(1):29. doi: 10.1186/s40249-020-00646-x.
Adler A, Arnold JH, Bayford R, Borsic A, Brown B, Dixon P, Faes TJ, Frerichs I, Gagnon H, Garber Y, Grychtol B, Hahn G, Lionheart WR, Malik A, Patterson RP, Stocks J, Tizzard A, Weiler N, Wolf GK. GREIT: a unified approach to 2D linear EIT reconstruction of lung images. Physiol Meas. 2009 Jun;30(6):S35-55. doi: 10.1088/0967-3334/30/6/S03. Epub 2009 Jun 2.
Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
Frerichs I, Becher T, Weiler N. Electrical impedance tomography imaging of the cardiopulmonary system. Curr Opin Crit Care. 2014 Jun;20(3):323-32. doi: 10.1097/MCC.0000000000000088.
Fumagalli J, Berra L. What does the Acute Respiratory Distress Syndrome trial (ART) teach us?-it is time for precision medicine and precision trials in critical care! J Thorac Dis. 2018 Mar;10(3):1300-1303. doi: 10.21037/jtd.2018.03.31. No abstract available.
Goh KJ, Choong MC, Cheong EH, Kalimuddin S, Duu Wen S, Phua GC, Chan KS, Haja Mohideen S. Rapid Progression to Acute Respiratory Distress Syndrome: Review of Current Understanding of Critical Illness from Coronavirus Disease 2019 (COVID-19) Infection. Ann Acad Med Singap. 2020 Mar 16;49(3):108-118.
Huh JW, Jung H, Choi HS, Hong SB, Lim CM, Koh Y. Efficacy of positive end-expiratory pressure titration after the alveolar recruitment manoeuvre in patients with acute respiratory distress syndrome. Crit Care. 2009;13(1):R22. doi: 10.1186/cc7725. Epub 2009 Feb 24.
Liu S, Tan L, Moller K, Frerichs I, Yu T, Liu L, Huang Y, Guo F, Xu J, Yang Y, Qiu H, Zhao Z. Identification of regional overdistension, recruitment and cyclic alveolar collapse with electrical impedance tomography in an experimental ARDS model. Crit Care. 2016 May 3;20(1):119. doi: 10.1186/s13054-016-1300-y.
Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis. 1988 Sep;138(3):720-3. doi: 10.1164/ajrccm/138.3.720. No abstract available.
Sahetya SK, Hager DN, Stephens RS, Needham DM, Brower RG. PEEP Titration to Minimize Driving Pressure in Subjects With ARDS: A Prospective Physiological Study. Respir Care. 2020 May;65(5):583-589. doi: 10.4187/respcare.07102. Epub 2019 Nov 26.
Thomas P, Baldwin C, Bissett B, Boden I, Gosselink R, Granger CL, Hodgson C, Jones AY, Kho ME, Moses R, Ntoumenopoulos G, Parry SM, Patman S, van der Lee L. Physiotherapy management for COVID-19 in the acute hospital setting: clinical practice recommendations. J Physiother. 2020 Apr;66(2):73-82. doi: 10.1016/j.jphys.2020.03.011. Epub 2020 Mar 30.
Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.
Silveira LTYD, Silva JMD, Tanaka C, Fu C. Decline in functional status after intensive care unit discharge is associated with ICU readmission: a prospective cohort study. Physiotherapy. 2019 Sep;105(3):321-327. doi: 10.1016/j.physio.2018.07.010. Epub 2018 Aug 2.
Novaes APL, Campos SL, Leite WS, Morais CC, de Andrade AFD, Goncalves ACE, Moraes F, Brandao DC. Comparison Among Three PEEP Titration Methods Monitored by Electrical Impedance Tomography in COVID-19. Respir Care. 2023 Dec 28;69(1):106-109. doi: 10.4187/respcare.10627. No abstract available.
Other Identifiers
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COVIDPTcare
Identifier Type: -
Identifier Source: org_study_id
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