[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07277244":3,"trial-entities:NCT07277244":141,"trial-summary:NCT07277244":146},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":106,"minimum_age":107,"maximum_age":108,"healthy_volunteers":14,"eligibility_criteria":109,"std_ages":118,"locations":121,"central_contacts":130,"overall_officials":131,"references":132,"see_also_links":140},"NCT07277244","2025P000986","Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study","ENROLLING_BY_INVITATION","2027-03-31","2026-06","2026-06-02","2026-04-02","Beth Israel Deaconess Medical Center","OTHER",false,"The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. The feasibility of this ventilation bundle will also be assessed.","The investigators hypothesize that protective low-intensity mechanical ventilation during robot-assisted surgery reduces perioperative atelectasis and postoperative pulmonary complications.",[18,19],"Robotic Surgery","Post Operative Pulmonary Complications",[21,22],"Lung protective ventilation","Electric Impedance Tomography (EIT)","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},60,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Low Intensity Mechanical Ventilation","A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure:\n\n1. Recruitment maneuver\n2. Tidal volume set to 8 ml\u002Fkg predicted body weight (PBW) and stepwise adjustment to achieve a driving pressure (Plateau pressure - PEEP) \\\u003C 13 cmH2O with a minimum tidal volume of 5ml\u002Fkg PBW\n3. Respiratory rate adjustment to maintain a target end-tidal carbon dioxide concentration (etCO₂) between 45 and 55 mmHg.\n4. Reassessment and adaptation after Trendelenburg positioning and pneumoperitoneum.\n5. Re-adjustment of Tidal Volume and PEEP ventilator settings to (2.) after exsufflation and return to the supine position. FiO₂ set to 70% during the washout phase of the inhalational anesthetic until extubation.",[36],"Intervention",[38],{"measure":39,"description":40,"timeFrame":41},"ΔEELV between baseline and after extubation before leaving the operating room.","Change in end-expiratory lung volume (EELV), measured using electrical impedance tomography between baseline and after extubation before leaving the operating room.","Perioperative Day 0: From pre-intubation baseline in the operating room (prior to induction of anesthesia) to the first post-extubation EIT assessment (within 10 min after extubation on Day 0).",[43,47,51,54,57,61,65,69,72,75,78,81,85,88,92,95,98,102],{"measure":44,"description":45,"timeFrame":46},"Proportion of patients with postoperative pulmonary complications at day 7","Re-intubation, hypoxemia requiring oxygen therapy, pleural effusion, pneumonia, atelectasis or emergency non-invasive ventilation","This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery",{"measure":48,"description":49,"timeFrame":50},"Change in right-ventricular systolic function (TAPSE, mm) from pre-intubation baseline to first post-extubation echocardiogram","Right-ventricular systolic function will be assessed by transthoracic echocardiography using tricuspid annular plane systolic excursion (TAPSE, measured in millimeters). TAPSE will be recorded at pre-intubation baseline and at the first postoperative transthoracic echocardiographic examination after extubation. The primary outcome for this measure will be the change in TAPSE (post-extubation minus baseline, mm).","Perioperative Day 0: before anesthesia and after PEEP\u002FTV\u002FRR titration",{"measure":52,"description":53,"timeFrame":50},"Change in right-ventricular fractional area change (RV-FAC, %) from pre-intubation baseline to first post-extubation echocardiogram","Right-ventricular systolic function will be assessed by transthoracic echocardiography using right-ventricular fractional area change (RV-FAC, expressed as percentage). RV-FAC will be recorded at pre-intubation baseline and at the first postoperative transthoracic echocardiographic examination after extubation. The outcome for this measure will be the change in RV-FAC (post-extubation minus baseline, %).",{"measure":55,"description":56,"timeFrame":50},"Change in left ventricular ejection fraction (LVEF, %) from pre-intubation baseline to first post-extubation echocardiogram","Left ventricular systolic function will be assessed by transthoracic echocardiography using left ventricular ejection fraction (LVEF, expressed as percentage). LVEF will be recorded at pre-intubation baseline and at the first postoperative transthoracic echocardiographic examination after extubation. The outcome for this measure will be the change in LVEF (post-extubation minus baseline, %).",{"measure":58,"description":59,"timeFrame":60},"Recruitment rate","Proportion of patients enrolled in the study-defined as those who provided acceptance and signed informed consent-relative to all patients approached.","Day 0",{"measure":62,"description":63,"timeFrame":64},"Intervention deliverability","proportion of patients in the intervention arm in whom the full bundle of protective low-intensity ventilation strategies is delivered as planned across all predefined intraoperative phases.","From intubation to extubation at Day 0",{"measure":66,"description":67,"timeFrame":68},"EELV","End-expiratory lung volume measured by Electrical Impedance Tomography in mL","Perioperative Day 0: before anesthesia, after intubation, after PEEP\u002FTV\u002FRR titration, after insufflation and positioning, after PEEP\u002FTV\u002FRR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission",{"measure":70,"description":71,"timeFrame":68},"COV","Center of ventilation measured by Electrical Impedance Tomography in percentage",{"measure":73,"description":74,"timeFrame":68},"RVDI","Regional ventilation delay inhomogeneity measured by Electrical Impedance Tomography (unitless)",{"measure":76,"description":77,"timeFrame":68},"GI","Global inhomogeneity index measured by Electrical Impedance Tomography (unitless)",{"measure":79,"description":80,"timeFrame":68},"Dorsal ROI","Maximum dorsal ratio of impedance measured by Electrical Impedance Tomography (unitless)",{"measure":82,"description":83,"timeFrame":84},"EEPL","End-expiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O)","Perioperative Day 0: after intubation, after PEEP\u002FTV\u002FRR titration, after insufflation and positioning, after PEEP\u002FTV\u002FRR reassessment, just before extubation",{"measure":86,"description":87,"timeFrame":84},"EIPL","End-inspiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O)",{"measure":89,"description":90,"timeFrame":91},"Relationship between body mass index with optimal PEEP","Correlation between BMI (kg\u002Fm²) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery.","Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery",{"measure":93,"description":94,"timeFrame":91},"Relationship of the degree of Trendelenburg inclination with optimal PEEP","Correlation between the degree of Trendelenburg inclination (in degree) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery.",{"measure":96,"description":97,"timeFrame":91},"Relationship of the pneumoperitoneum (insufflation) with optimal PEEP","Correlation between the pneumoperitoneum (insufflation in cmH2O) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery.",{"measure":99,"description":100,"timeFrame":101},"Intraoperative oxygenation","Intraoperative peripheral pulsed oxygen saturation (SpO2)","Perioperative Day 0: before anesthesia, after intubation, after PEEP\u002FTV\u002FRR titration, after insufflation and positioning, after PEEP\u002FTV\u002FRR reassessment, just before extubation, after extubation",{"measure":103,"description":104,"timeFrame":105},"Postoperative oxygenation","Postoperative peripheral pulsed oxygen saturation (SpO2)","Postoperative Day 0: after PACU admission and 60min after PACU admission","ALL","18 Years",null,{"inclusion":110,"exclusion":112,"raw_text":117},[111],"Adult patients undergoing non-emergent intra-abdominal or pelvic robot-assisted surgery with an expected duration of at least 2 hours, under general anesthesia with planned extubation at the end of the procedure",[113,114,115,116],"Known pregnancy","Pre-existing intubation or tracheostomy","Contraindications for esophageal manometry: severe midface trauma or recent nasal surgery, esophageal varices, recent gastric or esophageal surgery","Contraindications for electrical impedance tomography (EIT): inability to place EIT belt, presence of an active electronic implantable device (e.g., pacemaker, ICD)","Inclusion Criteria:\n\n* Adult patients undergoing non-emergent intra-abdominal or pelvic robot-assisted surgery with an expected duration of at least 2 hours, under general anesthesia with planned extubation at the end of the procedure\n\nExclusion Criteria:\n\n* Known pregnancy\n* Pre-existing intubation or tracheostomy\n* Contraindications for esophageal manometry: severe midface trauma or recent nasal surgery, esophageal varices, recent gastric or esophageal surgery\n* Contraindications for electrical impedance tomography (EIT): inability to place EIT belt, presence of an active electronic implantable device (e.g., pacemaker, ICD)",[119,120],"ADULT","OLDER_ADULT",[122],{"facility":12,"city":123,"state":124,"zip":125,"country":126,"geoPoint":127},"Boston","Massachusetts","02115","United States",{"lat":128,"lon":129},42.35843,-71.05977,[],[],[133,137],{"pmid":134,"type":135,"citation":136},"29793604","RESULT","Schaefer MS, Treschan TA, Gauch J, Neukirchen M, Kienbaum P. Influence of xenon on pulmonary mechanics and lung aeration in patients with healthy lungs. Br J Anaesth. 2018 Jun;120(6):1394-1400. doi: 10.1016\u002Fj.bja.2018.02.064. Epub 2018 Apr 13.",{"pmid":138,"type":135,"citation":139},"25018668","Schaefer MS, Wania V, Bastin B, Schmalz U, Kienbaum P, Beiderlinden M, Treschan TA. Electrical impedance tomography during major open upper abdominal surgery: a pilot-study. BMC Anesthesiol. 2014 Jul 5;14:51. doi: 10.1186\u002F1471-2253-14-51. eCollection 2014.",[],{"nct_id":4,"conditions":142,"biomarkers":145},[143,144],"Postoperative Pulmonary Complications","Robot-Assisted Surgery",[],{"nct_id":4,"found":14,"summary":108,"prompt_version":108}]