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The goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric impedance tomography imaging.
Obese patients under mechanical ventilation are more likely to develop atelectasis as a consequence of the increased abdominal weight. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support.
In a previous study we demonstrated the efficacy of the application of titrated PEEP levels following a recruitment maneuver in obese patients, i.e. improvement in respiratory mechanics and gas exchanges without negative hemodynamic effects.
The application of lung and heat imaging will allow us to quantitatively describe:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEP_Titration_INCREMENTAL | Experimental | The investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP incremental value is based in transpulmonary pressure. Intervention : PEEP INCREMENTAL |
|
| PEEP_Titration_DECREMENTAL | Experimental | The investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP decremental value is based in lung recruitment maneuver followed by a best compliance curve during PEEP decrements. Intervention :PEEP DECREMENTAL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEP INCREMENTAL | Procedure | PEEP was progressively increased by steps of 2 cmH2O every 60 second until the end-expiratory transpulmonary pressure became positive between 0-2 cmH2O. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory System Elastance | Difference in Respiratory System Elastance measured in cmH2O/L | During study time points :baseline, PEEP incremental, PEEP decremental |
| Measure | Description | Time Frame |
|---|---|---|
| Lung mechanics - Compliance | Difference in respiratory system, lung and chest wall compliance measured in mL/cmH2O | Study time points: baseline, PEEP incremental, PEEP decremental |
| Lung mechanics - Airway resistances |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-abdominal pressure | Changes in bladder pressure measured in mmHg. | Study time point: baseline |
| Electrical Impedance Tomography measurement: collapsed and overdistension | Percentage of lung tissue collapsed and over distended at different PEEP levels by analyzing pixel compliance ( variation in impedance divided by applied pressure during a respiratory cycle). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Kacmarek, RRT, PhD | Massachusetts General Hospital | Principal Investigator |
| Lorenzo Berra, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24467647 | Background | Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI. | |
| 19910329 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D012131 | Respiratory Insufficiency |
| D006333 | Heart Failure |
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Physiologic crossover study. There is no randomization. All participants will receive the same interventions in the same order.
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|
| PEEP DECREMENTAL | Procedure | Lung recruitment maneuver (LRM) is a transitory and controlled increase in airway pressure to open collapsed alveoli. LRM is the first step of the PEEP DECREMENTAL method. After LRM, PEEP is systematically decreased, in small decrements, until the best respiratory system mechanics is identified. |
|
|
Difference in resistances of the airways measured as cmH2O/L/sec (Raw)
| During study time points: baseline, PEEP incremental, PEEP decremental |
| Survival | Incidence of death among the study population | 28 days after the performance of the study protocol |
| Study time points: baseline, PEEP incremental, PEEP decremental |
| Electrical Impedance Tomography measurement: distribution of ventilation | Difference in end-expiratory lung impedance as percentage estimating the distribution of ventilation among 4 horizontal regions of interest ( from non-dependent to dependent lung regions). | Study time points: baseline, PEEP incremental, PEEP decremental |
| Electrical Impedance Tomography measurement: lung perfusion | Differences in distribution in lung perfusion measured as regional percentage of the total cardiac output. | Study time points: baseline, PEEP incremental, PEEP decremental |
| Central venous pressure | Changes in central venous pressure (CVP, mmHg) | Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures |
| Gas Exchange - Oxygenation | Difference in oxygenation measured in mmHg of PaO2/FiO2 | Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures |
| Gas Exchange - Arterial carbon dioxide | Difference in arterial carbon dioxide measured in mmHg (PaCO2) | Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures |
| Lung volumes - respiratory dead space | Difference in dead space fraction measured as the ratio of death volume over the total tidal volume (Vd/Vt) | Study time points: baseline, PEEP incremental, PEEP decremental. |
| Heart rate | Changes in heart rate (HR, bpm) | Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures |
| Blood pressure | Changes in invasive arterial blood pressures (BP, mmHg) | A) 48 and 24h before study procedures B)Study time points: baseline, PEEP incremental, PEEP decremental C)Follow up: 1, 2 , 24, 48 and 72 hours after study procedures. |
| Right heart function -Tricuspid Annular Plane Systolic Excursion (TAPSE) | Differences in TAPSE measured through two-dimensional transthoracic echocardiography (apical four-chamber view). | Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures |
| Right heart function - S' | Differences in the systolic excursion of the tricuspid annulus measured by tissue doppler imaging. | Study time points: baseline, PEEP incremental, PEEP decremental. Follow up: 1, 2 , 24 and 48 hours after study procedures |
| Right heart function - Tei index | Differences in global right ventricular function obtained from right ventricle tissue doppler imaging. | Study time points: baseline, PEEP incremental, PEEP decremental |
| Vasopressor requirement | Norepinephrine (mcg/kg/min), epinephrine (mcg/kg/min) , phenylephrine ( mcg/kg/min) and vasopressin (U / min) | 48, 24h before AND 24, 48 and 72h after study procedures. |
| Creatinine | Serum level of creatinine | 48, 24h before AND 24, 48 and 72h after study procedures. |
| Urinary output | Changes in urinary output (mL) | 48, 24h before AND 24, 48 and 72h after study procedures. |
| Fluid balance | Changes in fluid balance (mL) | 48, 24h before AND 24, 48 and 72h after study procedures. |
| Incidence of tracheostomy | Necessity of tracheostomy for prolonged ventilatory support among the study population | 28 days after the performance of the study protocol |
| Duration of mechanical ventilation | Number of days on mechanical ventilation | 28 days after the performance of the study protocol |
| Intensive care unit length of stay | Numbers of days spent in the intensive care | 28 days after the performance of the study protocol |
| Hospital length of stay | Numbers of days spent in the hospital | 28 days after the performance of the study protocol |
| Background |
| Behazin N, Jones SB, Cohen RI, Loring SH. Respiratory restriction and elevated pleural and esophageal pressures in morbid obesity. J Appl Physiol (1985). 2010 Jan;108(1):212-8. doi: 10.1152/japplphysiol.91356.2008. Epub 2009 Nov 12. |
| 21960654 | Background | Borges JB, Suarez-Sipmann F, Bohm SH, Tusman G, Melo A, Maripuu E, Sandstrom M, Park M, Costa EL, Hedenstierna G, Amato M. Regional lung perfusion estimated by electrical impedance tomography in a piglet model of lung collapse. J Appl Physiol (1985). 2012 Jan;112(1):225-36. doi: 10.1152/japplphysiol.01090.2010. Epub 2011 Sep 29. |
| 19809292 | Background | Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb. |
| 14693669 | Background | Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23. |
| 19186406 | Background | Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c. |
| 25732449 | Background | Krishnan S, Schmidt GA. Acute right ventricular dysfunction: real-time management with echocardiography. Chest. 2015 Mar;147(3):835-846. doi: 10.1378/chest.14-1335. |
| 12548024 | Background | Vieillard-Baron A, Jardin F. Why protect the right ventricle in patients with acute respiratory distress syndrome? Curr Opin Crit Care. 2003 Feb;9(1):15-21. doi: 10.1097/00075198-200302000-00004. |
| 32876469 | Derived | De Santis Santiago R, Teggia Droghi M, Fumagalli J, Marrazzo F, Florio G, Grassi LG, Gomes S, Morais CCA, Ramos OPS, Bottiroli M, Pinciroli R, Imber DA, Bagchi A, Shelton K, Sonny A, Bittner EA, Amato MBP, Kacmarek RM, Berra L; Lung Rescue Team Investigators. High Pleural Pressure Prevents Alveolar Overdistension and Hemodynamic Collapse in Acute Respiratory Distress Syndrome with Class III Obesity. A Clinical Trial. Am J Respir Crit Care Med. 2021 Mar 1;203(5):575-584. doi: 10.1164/rccm.201909-1687OC. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |