[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567994":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":50,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute hypoxemic respiratory failure","EXPERIMENTAL","Participants (n = 40) with acute hypoxemic respiratory failure will receive inhaled nitric oxide (20 ppm) for 15 min.",[13],"Device: Nitric oxide",{"label":15,"type":16,"description":17,"interventionNames":18},"Participants without acute hypoxemic respiratory failure","NO_INTERVENTION","Participants (n = 20) without acute hypoxemic respiratory failure will not receive inhaled nitric oxide",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Nitric oxide","20ppm for 15 minutes delivered by INO max(Nitric Oxide) Company : INO therapeutics, Inc.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Timothy Gaulton, MD, MSc","CONTACT","6177263030","tgaulton@mgh.harvard.edu",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},"Maurizio Cereda, MD","mcereda@mgh.harvard.edu",[35],{"facility":5,"status":18,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Boston","Massachusetts","02114","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-71.05977,42.35843,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":29,"phoneExt":18,"email":30},"Timothy Gaulton, MD, Msc",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Timothy G. Gaulton, MD","Assistant Professor of Anaesthesia","100567994","inhaled-nitric-oxide-in-severe-obesity-100567994",false,"NCT06675435","Inhaled Nitric Oxide in Severe Obesity","The Effect of Inhaled Nitric Oxide on Intrapulmonary Shunt in Acutely Hypoxemic Patients With Severe Obesity","For participants with acute hypoxemic respiratory failure\n\nInclusion Criteria:\n\n* Acute hypoxemic respiratory failure, defined as persistent hypoxemia (PaO2\u002FFiO2 ≤ 300 mmHg or SpO2\u002FFiO2 ≤ 315) and on invasive mechanical ventilation for \\\u003C 72 hours\n* Presence of an arterial and central venous catheter (for blood gas measurement)\n* Admitted to a participating MGH ICU\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy or known active breastfeeding\n* Prisoner or Incarceration\n* Inability or unwillingness of subject or legal surrogate\u002Frepresentative to give written informed consent\n* Use of inhaled or oral pulmonary vasodilatory therapy within the 24 hours preceding study enrollment\n* Contraindication to inhaled NO\n\n  * Baseline Methemoglobin ≥ 3%\n  * Known left ventricle ejection fraction \\\u003C 20%\n  * Known history of G6PD deficiency or cytochrome issues\n  * Prior adverse reaction to inhaled nitric oxide\n* Presence of pneumothorax or acute pulmonary embolism\n* Chronic hypoxemia requiring home supplemental non-invasive oxygen (nasal cannula or positive pressure ventilation) or home mechanical ventilation\n* Chronic pulmonary vascular disease on home chemical vasodilator support (e.g., sildenafil)\n* History of lung resection or transplant\n* Hemodynamic instability at the time of potential study enrollment defined as:\n\n  * Persistent systolic blood pressure \\\u003C 90 mmHg or \\>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\nEIT assessments of lung perfusion will only be performed in participants who are already receiving neuromuscular blocking agents (e.g., cisatracurium) at the time of study enrollment. EIT assessments of lung perfusion will not be performed in participants who have the following contraindications to EIT perfusion monitoring:\n\n* Hypernatremia (serum sodium \\> 150 mEq\u002FL)\n* Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator\n\nFor controls without acute hypoxemic respiratory failure\n\nInclusion Criteria:\n\n* Receiving invasive mechanical ventilation and do not have a diagnosis of acute hypoxemic respiratory failure (PaO2\u002FFiO2 \\> 300 mmHg or SpO2\u002FFiO2\\> 315)\n* Presence of an arterial catheter\n* Admitted to a participating MGH ICU\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy or known active breastfeeding\n* Prisoner or Incarceration\n* Inability or unwillingness of subject or legal surrogate\u002Frepresentative to give written informed consent","ALL","18 Years",{"count":64,"type":65},60,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this clinical trial is to learn about the effects of inhaled nitric oxide on oxygenation and lung perfusion in participants with severe obesity who have acute hypoxemic respiratory failure and are on mechanical ventilation\n\nThe main questions it aims to answer are:\n\n1. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on oxygenation in participants with severe obesity compared to participants with normal body weight.\n2. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on lung perfusion and heart function in participants with severe obesity compared to participants with normal body weight.\n3. In acute hypoxemic respiratory failure, does severe obesity impact nitric oxide signaling pathways?\n\nParticipants with acute hypoxemic respiratory failure will be exposed to inhaled nitric oxide (20 ppm) while being clinically monitored.",[71,72,73,74],"Obesity","Respiratory Insufficiency","Hypoxemic Respiratory Failure","Nitric Oxide",[76,77,78,79],"severe obesity","acute hypoxemic respiratory failure","intrapulmonary shunt","inhaled nitric oxide","NOT_YET_RECRUITING","2026-05-19",{"date":83,"type":84},"2026-05-20","ACTUAL",{"date":86,"type":65},"2026-10",{"date":88,"type":65},"2028-12",{"name":5,"class":6},1]