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The mortality of patients with acute respiratory distress syndrome (ARDS) remains high despite recent advances in lung-protective strategies and even after the overall improvement in intensive care (management of sepsis, hemodynamics, organ failure, and control of nosocomial infections). The use of mechanical ventilation (MV) plays a fundamental therapeutic role in this scenario. It allows for respiratory muscle rest, maintenance of oxygen transport to tissues, elimination of CO2 production, and finally, lung rest and protection in patients with excessive ventilatory demand.
On the other hand, recent studies have also shown that MV can cause iatrogenic injury and inflammation in the lung parenchyma, imposing a significant mechanical energy load and dissipation in the lung parenchyma (mechanotransduction). This effect is more pronounced in patients with low lung compliance or in those receiving inadvertently high tidal volumes, resulting in high distending pressure. Thus, despite being life-saving in the short term, MV may perpetuate or exacerbate pre-existing lung injury.
Various strategies have been proposed to aid in the ventilatory management of patients with ARDS. Among them, the use of higher PEEP values and the prone position have proven beneficial, especially when resulting in the stabilization of diseased alveoli or even promoting the recruitment of new alveolar units, associated with improved gas exchange. Both maneuvers, however, involve considerable risks: PEEP often causes impairments to venous return, and the prone position presents technical/logistical limitations for its widespread use, or even severe adverse effects during its implementation (ocular injury, accidental extubation, arrhythmias, catheter disconnection, etc.).
The hypothesis of this study is that automated lateral decubitus positioning (performed by a rotational bed with proper patient support), guided by monitoring through Electrical Impedance Tomography (EIT), could replace or minimize the need for prone positioning or the need for higher PEEPs in critical patients, resulting in effective alveolar recruitment and improvements in gas exchange, compliance, and lung aeration without affecting the hemodynamic condition.
The objective will be to estimate the efficacy and validate the feasibility of this alveolar recruitment protocol through the automated rotation of the patient, without the need for high airway pressures.Also the aim to demonstrate that this protocol is safe, with fewer repercussions on the hemodynamics of critically ill patients. To achieve this, a prospective, randomized study were conduct in two populations of critically ill patients: Sample-1) patients in the postoperative period of cardiac surgery, with a PF ratio of less than 250 (N=50 patients) admitted to the post-anesthesia care unit of Incor for extubation, and Sample-2) patients with ARDS or acute hypoxemic respiratory failure, with a PF ratio of less than 250, requiring mechanical ventilation (N=30 additional patients), and necessarily presenting an asymmetric (>65%/35%) distribution of ventilation on the functional map of Electrical Impedance Tomography (EIT) while in the supine position. A stratified randomization (1:1) within each of these samples of 30 patients will be done by computer.
For Sample 1 - the control group will undergo an ARDSNet-type ventilatory strategy, with PEEP adjustment according to BMI, based on previous studies that evaluated PEEP titrated by EIT in relation to BMI; and for Sample 2 - the ARDSNet-type ventilatory strategy, with PEEP adjustment according to the "low PEEP/FIO2" oxygenation table. All patients will remain on mechanical ventilation for at least 4 hours and will be monitored with EIT throughout the study. In postoperative patients, the rotation of the treatment group will follow the sequence "supine - lateral - supine - lateral - supine," with 10 minutes in each supine position and 20 minutes in each lateral position, and the first rotated side is defined as the lung with less ventilation being placed in a non-dependent position with a maximum PEEP of 24 cmH2O. In patients with asymmetric injury (acute hypoxemic respiratory failure), the lateralization sequence will be "supine-lateral with the better lung dependent-supine," meaning that the rotation will be unilateral, with 20-minute lateral position times alternated with another 10 minutes in the supine position. Recruitment maneuvers routinely used by the institution may be used as a rescue for any patient and will be mandatory at the end of the 4-hour study period in all postoperative patients (Sample 1, both treatment arms). The maneuvers will be performed with controlled pressure ventilation, a maximum PEEP of 30 cmH2O, with maximum inspiratory pressures of 50 cmH2O, for a maximum time of 30 seconds. These maneuvers will not be applied to patients with asymmetric injury (Sample 2, acute hypoxemic respiratory failure).
The main variables for comparison between the arms of each population sample will be: a) lung collapse and hyperdistension, b) shunt and PF ratio, c) ventilatory ratio (as a "surrogate" for dead space), d) global lung mechanics, e) regional mechanics by EIT, and f) continuous measurements of cardiac output (Volume-View, Baxter), frequency, and mean arterial pressure. These variables will be collected during the baseline period and after the recruitment maneuver for Sample 1, and after 24 hours of intervention for Sample 2.
The main hypothesis is that rotational therapy can increase regional transpulmonary pressure (in the non-dependent region after rotation), resulting in effective alveolar recruitment, evidenced by an improvement in PF ratio, global compliance, and regional compliance after returning to the supine position in both patient populations. In the case of patients with asymmetric lung injury (Sample 2), a effect is expecting within the following 24 hours compared to the control therapy. In the case of patients with symmetric injury, these effects can also be compared with the effects obtained by the more aggressive and traditional recruitment maneuver to be performed at the end of the observation period. As a secondary hypothesis, it was to intend to demonstrate that the therapy will cause minimal hemodynamic impairment compared to the control arm, and also less hemodynamic impairment when compared to the traditional recruitment maneuver at the end of the study (for postoperative patients).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral Positioning | Experimental | Sample1- Ventilator settings where adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment for both sides. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O. Sample2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT. |
|
| Control Group | No Intervention | Sample 1- The ventilator settings adjusted with PEEP based on BMI and remained in the supine position for the entire time. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O.Sample 2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational Therapy | Procedure | Sample1- Ventilator settings where adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment for both sides. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O. Sample2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT. |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Collapse | Lung Collapse will be measured using the information provided by the EIT that uses the Costa method | Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures. |
| Lung compliance | Lung compliance (mL/cmH2O) will be measured using the information provided by the EIT that uses the movement equation | Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures. |
| Oxygenation | Oxigenation will be assessed using the partial pressure arterial oxygen/fraction inspired oxygen ratio. Partial pressure arterial oxygen measured in the blood sample at the of each step and the fraction inspired oxygen set during the blood sample collection will be used. | Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures. |
| Shunt | Oxygenation will be assessed using the partial pressure arterial oxygen/fraction inspired oxygen at 1 ratio and partial pressure arterial oxygen and partial pressure of oxygen in venous blood will be collected an calculated manual using the formula Q/Qt= (CcO2-Ca02)-(CcO1-CvO2) where CcO2 (Pulmonary end-capillary O2 content); CvO2 (Mixed venous O2 content); CaO2(Arterial O2 content). | Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures. |
| Driving Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Volume | The hemodynamics were assessed through Stroke Volume using the EV1000™ clinical monitoring platform. | the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time |
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Inclusion Criteria:
Sample 1-
FiO2 ≥ 0.6 PEEP ≥ 8 cmH2O
Sample 2 -
FiO2 = 0.6 PEEP > 5 cmH2O
Both Samples:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo BP, MD PhD | University of Sao Paulo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo | São Paulo | 05403-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30260897 | Background | Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435. | |
| 19186406 |
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In Sample 1, intervention group patients had ventilator settings adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment, monitored by plethysmogram. PEEP was increased up to 4 cmH2O as needed. Afterward, patients returned to supine, and the process was repeated on the other side. The control group had similar ventilator settings but stayed supine. Both groups had an alveolar recruitment maneuver with increased pressures. In Sample 2, all patients underwent a 2-minute recruitment maneuver, followed by a 5-minute PEEP titration. The EIT-PEEP was identified and selected as the first PEEP above the crossing point of collapse and hyperdistension curves. Patients were then randomized, and PEEP was increased progressively based on randomization. The intervention group avoided traditional recruitment maneuvers, increasing PEEP gradually. This was followed by 4 hours of observation and a 24-hour follow-up
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|
Driving Pressure (cmH2O) will be measured using the information provided by the EIT that uses the movement equation
| Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures. |
| End Expiratory Lung Volume | will be measured using the information provided by the Electrical Tomography Impedance | Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures. |
| Lung Hyperextension | Lung Hyperextension (%) will be measured using the information provided by the EIT that uses the Costa method | Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures. |
| Plateau Pressure | Plateau Pressure( cmH2O) will be measured using the information provided by the EIT that uses the movement equation | Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures. |
| Ventilatory Distribution | will be measured using the information provided by the Electrical Tomography Impedance | Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures. |
| Diastolic Blood Pressure | The hemodynamics were assessed through Diastolic Blood Pressure using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil). | the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and |
| Stroke Volume Index | The hemodynamics were assessed through Stroke Volume Index using the EV1000™ clinical monitoring platform. | the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time |
| Cardiac Index | The hemodynamics were assessed through Cardiac Index using the EV1000™ clinical monitoring platform. | the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time |
| Cardiac Output | The hemodynamics were assessed through Cardiac Output using the EV1000™ clinical monitoring platform. | the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time |
| Systolic Volume Variation | The hemodynamics were assessed through Systolic Volume Variation using the EV1000™ clinical monitoring platform. | the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time |
| Mean Arterial Pressure | The hemodynamics were assessed through Mean Artial Pressure using the EV1000™ clinical monitoring platform for continous record and the the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil) for especifics times of colleted data. | the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time |
| Pulse Rate | The hemodynamics were assessed through Pulse Rate using the EV1000™ clinical monitoring platform. | the record throughout the duration of the protocol in the 20seconds of period of time |
| Systolic Blood Pressure | The hemodynamics were assessed through Diastolic Blood Pressure using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil). | the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and |
| Heart Rate | The hemodynamics were assessed through Diastolic Blood Pressure using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil). | the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization. |
| Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c. |
| 27169365 | Background | Hewitt N, Bucknall T, Faraone NM. Lateral positioning for critically ill adult patients. Cochrane Database Syst Rev. 2016 May 12;2016(5):CD007205. doi: 10.1002/14651858.CD007205.pub2. |
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| 28973363 | Background | Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171. |
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| 17038660 | Background | Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12. |
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| 30872586 | Background | Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0. |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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