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| Name | Class |
|---|---|
| InCor Heart Institute | OTHER |
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This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.
Mechanical ventilatory strategy of the ARDS Network low PEEP-FiO2 table will be followed in the control arm. This strategy consists of at least 12 hours of controlled mechanical ventilation following prespecified PEEP and FiO2 combinations chosen dynamically targeting oxygenation. Tidal volume is set at 4-6 mL/Kg of predicted body weight (PBW) and plateau pressure is kept below 30 centimeters of water (cmH2O). Respiratory rate can be as high as 35 breaths per minute titrated to a potential of hydrogen (pH) 7.30-7.45. As oxygenation improves, patients are transitioned to assisted ventilation and then to pressure support ventilation until they are ready to be liberated from the ventilator. During this phase, no attempt is made to control plateau pressures or tidal volumes. In the intervention arm, minimizing tidal lung strain by keeping driving pressure below 16 cmH2O throughout the mechanical ventilation period will be targeted. The controlled phase will last at least 48 hours. PEEP will be selected according to a PEEP titration maneuver with EIT at the start of the intervention. This PEEP level will be kept until extubation. Respiratory rate can be as high as 50 breaths per minute targeting a pH of 7.15-7.45.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARDSNet | Active Comparator | ARDSNet protocol (low PEEP-FiO2 table). Ventilatory mode: volume-controlled ventilation Tidal volume (VT) will be adjusted to 4-6 mL/Kg of PBW and Plateau pressure < 30 cmH2O for the at least the first 12 hours after inclusion in the protocol pH should be maintained between 7.35-7.45 Oxygenation (SpO2) target ranges 90-95% Maximum respiratory rate = 35 breaths/min PEEP and FIO2 adjusted according to the low PEEP-FiO2 Table. |
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| EIT-Group | Experimental | The goal is to maintain driving pressure (DP) < 16 cmH2O. Ventilatory mode: pressure-controlled ventilation After a recruitment a maneuver, PEEP will be chosen according to a PEEP titration maneuver monitored with electrical impedance tomography Plateau pressure may exceed 30 cmH2O and VT may exceed 6 mL/Kg if DP < 16 cmH2O pH should be maintained between 7.15-7.40 Oxygenation (SpO2) target ranges 90 -95% Maximum respiratory rate = 50 bpm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EIT-Group | Other | A mechanical ventilation strategy with the main goal to maintain DP < 16 cmH2O |
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| Measure | Description | Time Frame |
|---|---|---|
| Average daily Modified Lung injury score until day 28 | This score originally ranges from 0 to 4 points based on the average of 4 parameters (PaO2/FiO2, chest X-Ray, PEEP level, and Respiratory compliance). In the modified version, if the patient dies, he or she automatically receives a score of 5 irrespective of the other four parameters. If the patient is extubated, the score is automatically zero. We also substituted FiO2 for PEEP guaranteeing equivalence of the score when either the low or high PEEP-FiO2 table is applied. | daily |
| Measure | Description | Time Frame |
|---|---|---|
| High oxygen dependence free days until day 28 | Number of days with less than or equal to 1 Liter/min of oxygen supplementation until day 28 | 28 days |
| Mechanical ventilation free days until day 28 |
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Inclusion Criteria:
Patients under mechanical ventilation with ARDS (Berlin definition) caused by SARS-COV2 infection:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo LV Costa, PhD | Contact | +551130617361 | eduardoleitecosta@gmail.com | |
| Maria AM Nakamura, PhD | Contact | +551130617151 | mamiyukinakamura@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eduardo LV Costa, PhD | Hospital das Clinicas from University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USP Instituto do Coração | Recruiting | São Paulo | 05.403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39311582 | Derived | Alcala GC, Ekkapat G, Medeiros KJ, Morais CCA, Xin Y, Giammatteo V, Bruno G, Nova A, Wanderley H, Buhl T, Victor M, Gaulton TG, La Vita CJ, Amato MBP, Ceradda M, Berra L, Ribeiro De Santis Santiago R. Monitoring Lung Function with Electrical Impedance Tomography in the Intensive Care Unit. J Vis Exp. 2024 Sep 6;(211). doi: 10.3791/66756. | |
| 38849605 |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012141 | Respiratory Tract Infections |
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Prospective, randomized, single-center, open-label, superiority, controlled trial
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| ARDSNet | Other | Low PEEP-FiO2 table ARDS Network ventilation protocol |
|
Number of days free of mechanical ventilation assistance after protocol inclusion and before day 28
| 28 days |
| Incidence of shock or barotrauma | Occurrence of shock (persistent hypotension despite rescue measures) and incidence of barotrauma | 28 days |
| Incidence of acute renal failure requiring renal replacement therapy | Occurrence of acute renal failure that justifies renal replacement therapy | 28 days |
| 28-day mortality | Percentage of patients who died in each arm up to 28 days | 28 days |
| Costa ELV, Alcala GC, Tucci MR, Goligher E, Morais CC, Dianti J, Nakamura MAP, Oliveira LB, Pereira SM, Toufen C Jr, Barbas CSV, Carvalho CRR, Amato MBP. Impact of extended lung protection during mechanical ventilation on lung recovery in patients with COVID-19 ARDS: a phase II randomized controlled trial. Ann Intensive Care. 2024 Jun 8;14(1):85. doi: 10.1186/s13613-024-01297-z. |
| 35767435 | Derived | Hohmann F, Wedekind L, Grundeis F, Dickel S, Frank J, Golinski M, Griesel M, Grimm C, Herchenhahn C, Kramer A, Metzendorf MI, Moerer O, Olbrich N, Thieme V, Vieler A, Fichtner F, Burns J, Laudi S. Early spontaneous breathing for acute respiratory distress syndrome in individuals with COVID-19. Cochrane Database Syst Rev. 2022 Jun 29;6(6):CD015077. doi: 10.1002/14651858.CD015077. |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |