[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07019987":3,"trial-entities:NCT07019987":130,"trial-summary:NCT07019987":134},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":52,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":80,"locations":83,"central_contacts":103,"overall_officials":108,"references":109,"see_also_links":129},"NCT07019987","2025P001410","Adiposity Distribution in Acute Respiratory Failure","Imaging the Respiratory Effects of Truncal Adiposity in Acute Hypoxemic Respiratory Failure","NOT_YET_RECRUITING","2030-06-30","2025-06","2025-06-13","2028-01-01","Maurizio F. Cereda, MD","OTHER",true,"Acute Hypoxemic Respiratory Failure (AHRF) is a condition in which injury to the lungs impairs the ability of the air sacs (alveoli) to ventilate and exchange oxygen. This impairment may be worsened in individuals with elevated body weight, particularly when fat tissue compresses the lungs and promotes alveolar collapse. The impact of body weight on lung function may be greater in individuals with upper-body fat distribution.\n\nTwo common interventions for AHRF-positive end-expiratory pressure (PEEP) and prone positioning-are used to improve lung ventilation. However, it is unclear whether these therapies are equally effective across different body weight categories and fat distributions.\n\nThis study will evaluate whether body weight and fat distribution affect patients' lung inflation responses to PEEP and prone positioning. Lung inflation will be assessed using electrical impedance tomography (EIT), a bedside imaging tool that maps lung ventilation, and esophageal manometry, which estimates lung compression through a thin catheter placed in the esophagus. Laboratory tests will also be used to measure markers of inflammation and AHRF severity and find correlations with fat distribution and responses to the tested treatments..\n\nPatients with AHRF requiring mechanical ventilation will be enrolled across a range of body weights. Each participant will undergo combinations of two PEEP levels and two body positions (supine and prone) for 30 minutes each. At the end of the study procedures, clinical care will continue as determined by the treating team.","This study investigates the relationship between body habitus and the physiological response to ventilatory interventions in patients with Acute Hypoxemic Respiratory Failure (AHRF). The primary objectives are to determine:\n\n1. Whether excess body weight affects the regional lung inflation response to PEEP and prone positioning;\n2. Whether body fat distribution (e.g., central vs. peripheral) is associated with lung recruitment;\n3. Whether inflation responses correlate with laboratory markers of systemic inflammation and AHRF severity.\n\nAdult patients with AHRF requiring invasive mechanical ventilation will be screened daily in the intensive care units at Massachusetts General Hospital. The study team will coordinate with clinical staff and patient surrogates to obtain informed consent. Enrollment is limited to the period required to perform study-specific procedures. No follow-up visits or post-discharge interventions are planned.\n\nAfter consent, participants will be equipped with two adhesive EIT electrode belts, placed bilaterally on the thorax, to measure regional ventilation. A pressure and flow sensor will be placed in the breathing circuit at the proximal end of the endotracheal tube. An esophageal balloon catheter will be inserted nasally into the distal esophagus (approximately 35-40 cm) to measure intrathoracic pressure (ITP) via esophageal manometry, recorded through an auxiliary module on the EIT device.\n\nOnce all monitoring devices are in place, patients will be evaluated for adequate sedation and ventilator synchrony. Baseline data will be recorded during ventilation at the clinician-selected PEEP level (PEEP\\_CLIN), including EIT, airway pressure, flow, and ITP signals over 20 consecutive breaths.\n\nSubsequently, a PEEP titration trial will be conducted to identify an individualized PEEP value (PEEP\\_TIT) that minimizes both alveolar collapse and overdistension, using EIT-based criteria. The patient will then be ventilated at PEEP\\_TIT for 30 minutes, after which all measurements will be repeated.\n\nFollowing supine data collection, patients will be transitioned to the prone position using standard clinical protocols, with participation from ICU staff (physicians, nurses, and respiratory therapists) in accordance with institutional practice. Continuous monitoring (including pulse oximetry and arterial blood pressure) will be maintained throughout the repositioning.\n\nAfter achieving the prone position, a recruitment maneuver will be performed to standardize lung volume history. The EIT belts will then be reconnected, and the patient will be allowed to stabilize for 30 minutes at PEEP\\_CLIN before measurements are repeated. A second PEEP titration trial will be performed to determine PEEP\\_TIT in the prone position, followed by another 30-minute stabilization period and repeat data acquisition.\n\nArterial blood samples (2 mL each) will be obtained at each PEEP level in both positions (four total, 8 mL cumulative) for gas exchange analysis. An additional 10 mL sample will be collected during supine ventilation at PEEP\\_CLIN for biomarker analysis. Biomarkers of inflammation (e.g., IL-6, TNF-α, C-reactive protein) and adipose tissue-related factors (e.g., adiponectin, leptin, resistin) will be measured.\n\nAfter study procedures, participants will be returned to the supine position unless otherwise indicated by the clinical team. All subsequent clinical decisions regarding ventilator management or patient positioning will be made by the attending care team.\n\nThis study seeks to generate mechanistic insights into how excess body weight and fat distribution affect the physiologic response to standard ventilatory interventions in AHRF, with the goal of informing more individualized approaches to respiratory support.",[19,20],"Acute Hypoxemic Respiratory Failure","Obesity",[22,23,24,25,26,27,28],"acute hypoxemic respiratory failure","obesity","electrical impedance tomography","esophageal manometry","mechanical ventilation","prone positioning","positive end expiratory pressure","INTERVENTIONAL","DIAGNOSTIC",[32],"NA",{"count":34,"type":35},80,"ESTIMATED",[37,42],{"type":14,"name":38,"description":39,"armGroupLabels":40},"PEEP Titration Using Electrical Impedance Tomography (EIT)","EIT will be used to guide individualized PEEP titration in mechanically ventilated patients with AHRF. Each subject will receive mechanical ventilation at two PEEP levels:\n\nPEEP\\_CLIN (set by the treating clinician)\n\nPEEP\\_TIT (identified using EIT to minimize alveolar collapse and overdistension)\n\nBoth levels will be maintained for 30 minutes in each body position, with continuous physiologic data collected during each phase.",[41],"Single Arm: Ventilatory Assessment at Two PEEP Levels and Body Positions",{"type":43,"name":44,"description":45,"armGroupLabels":46},"PROCEDURE","Body Positioning: Supine and Prone","Each subject will be ventilated in both the supine and prone positions. Positioning will follow institutional protocols and be coordinated with clinical staff to ensure safety. After supine assessments are completed, the patient will be transitioned to prone, followed by a recruitment maneuver to standardize lung volume history. The PEEP titration protocol will then be repeated in the prone position.",[41],[48],{"measure":49,"description":50,"timeFrame":51},"Driving pressure with PEEP titration and prone position","The primary outcome will be the difference in driving pressure (inspiratory plateau pressure minus total PEEP, in cmH2O) in response to PEEP titration strategies and to prone position. Changes in driving pressure will be correlated with body mass index, and with measurements of thoracic, and abdominal circumference.","Day 1, after 30 minutes in each combination of PEEP and body position",[53],{"measure":54,"description":55,"timeFrame":51},"Regional ventilation","Changes in EIT-derived measurements of regional ventilation with PEEP titration and prone positioning. EIT regional ventilation is measured as percentage of total ventilation in each examined lung region.","ALL","18 Years","80 Years",false,{"inclusion":61,"exclusion":65,"raw_text":79},[62,63,64],"AHRF with PaO2\u002FFiO2 \\\u003C= 300 mmHg) intubated for less than 72 hours","Presence of an arterial line for blood gas measurement and blood pressure monitoring","18 years or older",[66,67,68,69,70,71,72,73,74,75,76,77,78],"Suspected pregnancy, pregnancy or less than six weeks postpartum","Younger than 18 years or older than 80 years.","Subject enrolled in another interventional research study","Presence of pneumothorax","Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator","Preexisting chronic lung disease or pulmonary hypertension","Acute cardiac failure causing pulmonary edema","Past medical history of lung malignancy or pneumonectomy, or lung transplant","Hemodynamic instability, defined as:","Persistent systolic blood pressure \\\u003C90 mmHg and\u002For \\>180 mmHg despite the use of vasopressor or vasodilators, or","Requiring an increment in inotropic-vasopressors over the past two hours just before enrollment: more than 15 mcg\u002Fmin for norepinephrine and dopamine, more than 10 mcg\u002Fmin in epinephrine; and more than 50 mcg\u002F min for phenylephrine.","Contraindications to placement in the prone position: complex abdominal surgical dressing, recent sternotomy, unstable spine or pelvic fractures, intracranial hypertension, serious facial injury","Extracorporeal life support","Inclusion Criteria:\n\n* AHRF with PaO2\u002FFiO2 \\\u003C= 300 mmHg) intubated for less than 72 hours\n* Presence of an arterial line for blood gas measurement and blood pressure monitoring\n* 18 years or older\n\nExclusion Criteria:\n\n* Suspected pregnancy, pregnancy or less than six weeks postpartum\n* Younger than 18 years or older than 80 years.\n* Subject enrolled in another interventional research study\n* Presence of pneumothorax\n* Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator\n* Preexisting chronic lung disease or pulmonary hypertension\n* Acute cardiac failure causing pulmonary edema\n* Past medical history of lung malignancy or pneumonectomy, or lung transplant\n* Hemodynamic instability, defined as:\n\n  * Persistent systolic blood pressure \\\u003C90 mmHg and\u002For \\>180 mmHg despite the use of vasopressor or vasodilators, or\n  * Requiring an increment in inotropic-vasopressors over the past two hours just before enrollment: more than 15 mcg\u002Fmin for norepinephrine and dopamine, more than 10 mcg\u002Fmin in epinephrine; and more than 50 mcg\u002F min for phenylephrine.\n* Contraindications to placement in the prone position: complex abdominal surgical dressing, recent sternotomy, unstable spine or pelvic fractures, intracranial hypertension, serious facial injury\n* Extracorporeal life support",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":100},"Massachusetts General Hospital","Boston","Massachusetts","02114","United States",[91,96],{"name":92,"role":93,"phone":94,"email":95},"Maurizio F Cereda, MD","CONTACT","6176430987","mcereda@mgh.harvard.edu",{"name":97,"role":93,"phone":98,"email":99},"Lorenzo Berra, MD","617 724 0743","lberra@mgh.harvard.edu",{"lat":101,"lon":102},42.35843,-71.05977,[104,106],{"name":92,"role":93,"phone":105,"email":95},"16176430987",{"name":97,"role":93,"phone":98,"email":107},"LBERRA@mgh.harvard.edu",[],[110,114,117,120,123,126],{"pmid":111,"type":112,"citation":113},"35388669","BACKGROUND","Hao D, Low S, Di Fenza R, Shenoy ES, Ananian L, Prout LA, La Vita CJ, Berra L. Prone Positioning of Intubated Patients with an Elevated Body-Mass Index. N Engl J Med. 2022 Apr 7;386(14):e34. doi: 10.1056\u002FNEJMvcm2108494. No abstract available.",{"pmid":115,"type":112,"citation":116},"33705371","Kompaniyets L, Goodman AB, Belay B, Freedman DS, Sucosky MS, Lange SJ, Gundlapalli AV, Boehmer TK, Blanck HM. Body Mass Index and Risk for COVID-19-Related Hospitalization, Intensive Care Unit Admission, Invasive Mechanical Ventilation, and Death - United States, March-December 2020. MMWR Morb Mortal Wkly Rep. 2021 Mar 12;70(10):355-361. doi: 10.15585\u002Fmmwr.mm7010e4.",{"pmid":118,"type":112,"citation":119},"19910329","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\u002Fjapplphysiol.91356.2008. Epub 2009 Nov 12.",{"pmid":121,"type":112,"citation":122},"32876469","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\u002Frccm.201909-1687OC.",{"pmid":124,"type":112,"citation":125},"34099131","Florio G, De Santis Santiago RR, Fumagalli J, Imber DA, Marrazzo F, Sonny A, Bagchi A, Fitch AK, Anekwe CV, Amato MBP, Arora P, Kacmarek RM, Berra L. Pleural Pressure Targeted Positive Airway Pressure Improves Cardiopulmonary Function in Spontaneously Breathing Patients With Obesity. Chest. 2021 Jun;159(6):2373-2383. doi: 10.1016\u002Fj.chest.2021.01.055. Epub 2021 May 8.",{"pmid":127,"type":112,"citation":128},"39285477","Spina S, Mantz L, Xin Y, Moscho DC, Ribeiro De Santis Santiago R, Grassi L, Nova A, Gerard SE, Bittner EA, Fintelmann FJ, Berra L, Cereda M. The pleural gradient does not reflect the superimposed pressure in patients with class III obesity. Crit Care. 2024 Sep 16;28(1):306. doi: 10.1186\u002Fs13054-024-05097-6.",[],{"nct_id":4,"conditions":131,"biomarkers":133},[132,20],"Acute hypoxemic respiratory failure",[],{"nct_id":4,"found":15,"summary":135,"prompt_version":145},{"design":136,"status":137,"heading":138,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This interventional study plans to enroll 80 participants. It is not specified if it is randomized or blinded.","completed","Study on PEEP Titration and Body Positioning in Acute Respiratory Failure","This study is looking at how body weight and fat distribution affect how well two common treatments work for Acute Hypoxemic Respiratory Failure (AHRF). AHRF is when your lungs can't get enough oxygen. The treatments being studied are PEEP Titration Using Electrical Impedance Tomography (EIT) and Body Positioning (supine and prone). Researchers want to see if these treatments improve lung function differently in people with various body types. You might be able to join if you are 18 to 80 years old, have AHRF, and are on a breathing machine. The main goal is to measure lung pressure changes with these treatments. The study is currently unclear on its recruitment status and plans to enroll 80 participants.","No follow-up visits or post-discharge interventions are planned.",117,"You will have EIT belts placed on your chest and a sensor in your breathing tube. You will be ventilated in both supine and prone positions for assessments.","Not stated in the trial record.",[38],"v2"]