Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidade Federal de Pernambuco | OTHER |
| Coordination for the Improvement of Higher Education Personnel | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
People affected by Severe Acute Respiratory Syndrome (SARS) by COVID-19 virus my require a long lasting invasive mechanical ventilation life support. To prevent damages to the lungs a number of protective lung ventilation measures are taken, one of them encounters the positive end expiratory pressure (PEEP) titration. Up to date, it is unclear the best method to titrate PEEP considering this unconventional syndrome compared to other etiologies. In addition to the long lasting advanced life support and bedridden condition, other factors may affect respiratory and peripheral muscle function of these patients. Therefore, the investigators intend to follow up these patients randomized to one of the three-arm experimental PEEP titration and after ICU discharge their status on clinical, laboratory and physical functions assessments.
Introduction: Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) requires mechanical ventilatory (MV) life support. In this scenario, lung protective strategies have been recommended for avoiding ventilator induced lung injuries mainly by inappropriate positive end expiratory pressure (PEEP) titration. However, the best method of PEEP titration for these patients remains unclear, since its clinical and morphofunctional phenotype may differ from the conventional acute respiratory distress syndrome (ARDS) phenotype resulted from other etiologies. In addition, these patients' condition of long lasting MV dependency and bed restriction may lead to deterioration of respiratory and peripheral muscles functions.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADRSNet protocol | Experimental | 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%) |
|
| Driving Pressure (DP) | Experimental | setting PEEP after performing a modified alveolar recruitment maneuver followed by a decremental PEEP titration electing the level correspondent to the lowest driving pressure. |
|
| Electrical Impedance Tomography (EIT) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARDSNet table | Other | The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Murray Score (LIS) | Scoring system for lung injury including hypoxemia, respiratory system compliance, chest radiographic findings and level of PEEP. The minimum value is zero and the maximum value is sixteen. The higher the score the worse outcome. | 4 hours |
| Potential lung recruitment measured during electrical impedance tomography | to quantify lung ventilation distribution | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of days in intensive care unit (ICU days) | to quantify the number of days spent in a critical care unit | Through study completion, an average of 1 year |
| Work of breathing (WOB) measured during surface electromyography |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shirley Lima Campos, PhD | Universidade Federal de Pernambuco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas - UFPE | Recife | Pernambuco | 50670-901 | Brazil | ||
| Physical Therapy Department, Universidade Federal de Pernambuco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32183901 | Background | 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. | |
| 19491438 |
Not provided
Not provided
end of trial
individual participant data (IPD) access will be granted by the PI after request review for approval via email. It will be shared with researchers and general public of interest on the subject for descriptive analyses related to our sample medical and clinical characteristics. A committee of researchers will be in charge of discussing the request before approving the access.
Not provided
Not provided
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
| Fundação de Amparo à Ciência e Tecnologia de Pernambuco | OTHER |
three groups of treatments (A, B and C) are given so that one group receives only A while another group receives only B and the third group receives only C. All volunteers will be randomized to one of the three groups of treatment.
Not provided
Not provided
trial participants, data collectors and outcome assessors or committees will remain blinded to the patient assigned group of treatment.
| Driving Pressure | Other | 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 | Other | The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver. |
|
measured in root-mean-squared electromyography signals
| 4 hours |
| Duration of mechanical ventilation (MV days) | to quantity the number of days with use of invasive mechanical ventilation in inpatients. | Through study completion, an average of 1 year |
| ICU Mortality | to quantify number of living days between ICU admission and deceased status | Through study completion, an average of 1 year |
| respiratory muscle strength | maximal static respiratory mouth pressures | Through study completion, an average of 1 year |
| Forced vital capacity (FVC) measured during spirometry | measures obtained by spirometry in outpatients | Through study completion, an average of 1 year |
| diaphragmatic mobility measured during ultrasonography | diaphragmatic excursion expressed in millimeters | Through study completion, an average of 1 year |
| diaphragmatic thickening measured during ultrasonography | diaphragmatic thickening expressed in millimeters | Through study completion, an average of 1 year |
| breathing pattern measured during airway flowmeter | a device to quantify airway flow | Through study completion, an average of 1 year |
| peripheral muscle strength I | to be evaluated by Medical Research Council's scale. The minimum score is 0 and the maximum is 60. The higher the score, the better outcome. | Through study completion, an average of 1 year |
| peripheral muscle strength II | to be evaluated by a handgrip dynamometers in outpatients | Through study completion, an average of 1 year |
| peripheral muscle strength III | to be evaluated by a handheld dynamometer in outpatients | Through study completion, an average of 1 year |
| six-minute walk test (6WT) | sub-maximal exercise test used to assess aerobic capacity and endurance in outpatients | Through study completion, an average of 1 year |
| functional capacity (Perme scale) | The minimum score is 0 and the maximum is 32. The higher the score, the better outcome. | Through study completion, an average of 1 year |
| daily activities performance | to be evaluated by Barthel Index in outpatients | Through study completion, an average of 1 year |
| quality of life measured by Short Form Health survey 36 | score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Through study completion, an average of 1 year |
| Recife |
| Pernambuco |
| 50670-901 |
| Brazil |
| Hospital da Mulher do Recife | Recife | Pernambuco | 50790-640 | Brazil |
| Hospital Geral Otavio de Freitas | Recife | Pernambuco | 50920-460 | Brazil |
| 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. |
| 30776290 | Background | 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. |
| 19255741 | Background | 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. |
| 32171076 | Background | 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. |
| 24739268 | Background | 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. |
| 29707281 | Background | 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. |
| 32200400 | Background | 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. |
| 19239703 | Background | 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. |
| 27142073 | Background | 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. |
| 3202424 | Background | 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. |
| 31772068 | Background | 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. |
| 32312646 | Background | 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. |
| 32139904 | Background | 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. |
| 30342701 | Background | 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. |
| 37580123 | Derived | 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. |