[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638342":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":25,"responsibleParty":43,"collaborators":25,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":25,"enrollmentInfo":55,"targetDuration":25,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":25},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mechanical power-guided ventilatory strategy","EXPERIMENTAL","In the intervention group, ventilatory settings will be personalized according to the mechanical power, after the surgical incision (whether laparoscopy or laparotomy), and after the pneumoperitoneum insufflation (for laparoscopy only) or stop of pneumoperitoneum insufflation.",[13],"Procedure: Mechanical power-guided ventilatory strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group with standard fixed ventilatory settings","ACTIVE_COMPARATOR","In the control group, standard care will be performed.",[19],"Procedure: Standard fixed ventilatory settings",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","1. Tidal volume 7ml\u002Fkg PBW and RR titrated for EtCO2 between 40-50mmHg. See calculated Mechanical power:0,049\\*tidal volume\\*RR\\*driving pressure.\n2. Set PEEP 15cmH2O and perform recruitment maneuver at 30cmH2O for 20s. Decrease PEEP from 15 by steps of 2cmH2O until the lower level of PEEP minimizing mechanical power. Note mechanical power. Stop maneuver and\u002For decrease level of PEEP if decrease\\>20% of cardiac output during the maneuver, when compared to baseline.\n3. Repeat this step using 9 ml\u002Fkg PBW and choose the optimal tidal volume with lowest mechanical power.\n\nDuring the surgery, adjust RR to maintain EtCO2 between 40-50mmHg, with an inspiratory-to-expiratory time ratio of 1:2 to 1:1, an end-inspiratory pause of 30%, an FiO2 adjusted to maintain SpO2≥94%. Recruitment maneuvers will be performed after intubation, in case of ventilator disconnection, coelioscopy insufflation, change of position, at the end of surgery, or if mechanical power \\>30%.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard fixed ventilatory settings","Tidal volume 7 ml\u002Fkg predicted body weight, calculated according to a predefined formula: 50+0.91 x (centimeters of height - 152.4) for males and 45.5+0.91 x (centimeters of height - 152.4) for females, fixed PEEP between 6 and 8 cmH20, recruitment maneuvers at the discretion of the physician.\n\nThe respiratory rate will be adjusted to maintain end-tidal partial pressure of CO2 between 30 and 40 mmHg, a target reported to be used by approximately 90% of physicians according to a recent online survey administered to French anesthesiologists via the French Society of Anesthesia \\& Intensive Care Medecine (SFAR), which will be published soon, with an inspiratory-to-expiratory time ratio of 1:2 to 1:1, an end-inspiratory pause of 30 %, and an FiO2 adjusted to maintain SpO2 ≥ 94%.\n\nMechanical power will not be measured during the surgery to avoid any modification of the ventilatory setting by the physician in charge.",[15],[31],{"name":32,"affiliation":5,"role":33},"Audrey DEBRUS, Dr","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Audrey DE JONG, Pr","CONTACT","04 67 33 72 71","a-de_jong@chu-montpellier.fr",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Samir JABER, Pr","s-jaber@chu-montpellier.fr",{"type":44,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100638342","mechanical-power-for-ventilatory-settings-in-operating-room-100638342",false,"NCT07620132","Mechanical Power for Ventilatory Settings in Operating Room","Mechanical Power for Ventilatory Settings in Operating Room: a Multicenter Randomized Controlled Trial","IMPROVEIII","Inclusion Criteria:\n\n* Adult (≥ 18 years)\n* Laparoscopic or non-laparoscopic abdominal surgery\n* With an expected duration of at least 2 hours\n\nExclusion Criteria:\n\n* Patients already receiving mechanical ventilation \\> 12 hours before surgery;\n* Chronic respiratory disease requiring oxygen therapy or mechanical ventilation at home;\n* Undrained pneumothorax or subcutaneous emphysema;\n* Intracranial hypertension;\n* Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 3 months;\n* Patients already enrolled in the IMPROVE III trial;\n* Pregnancy in progress or planned during the study period or breastfeeding women (Art. L1121-5 of the French Public Health Code);\n* Patients protected by law (Art. L1121-6 to L1121-8 of the French Public Health Code): Individuals deprived of their liberty by judicial or administrative decision, vulnerable persons, minors, adults under guardianship or curatorship;\n* Patients not covered by a French social security scheme and not benefiting from such a scheme;\n* Absence of free and informed oral consent from the patient before inclusion (except in emergency situation where the patient is unable to provide consent), or absence of written informed consent from his\u002Fher proxy if present in an emergency situation (except in life-threatening emergency, where inclusion without consent from the patient or his\u002Fher proxy is permitted), in which case consent will be obtained as soon as possible after inclusion.","ALL","18 Years",{"count":56,"type":57},490,"ESTIMATED","INTERVENTIONAL",[60],"NA","Postoperative respiratory failure (PRF) is a dreaded complication that imposes a significant burden through unplanned admission to the ICU, post discharge disability and mortality. Despite widespread implementation of intraoperative lung-protective ventilation strategies over the past decade, results remain inconsistent. Interventions targeting individual parameters like tidal volume or positive end-expiratory pressure (PEEP) have shown equivocal results. The use of high PEEP and recruitment maneuvers raises safety concerns by possible negative hemodynamic effects. Recent studies suggest that individualizing ventilation strategies based on mechanical power-a composite parameter integrating tidal volume, plateau pressure, PEEP, and ventilator frequency-may better predict and help prevent PRF, independently of patients' baseline respiratory system compliance. These studies identified this parameter as interventional targets to reduce lung injury during mechanical ventilation. However, no multicenter randomized controlled trial has been performed in the field of ventilatory settings titration during invasive mechanical ventilation in operating room.\n\nThe investigators hypothesize that a ventilation strategy aimed at decreasing mechanical power will reduce the incidence of PRF and mortality in patients undergoing abdominal surgery, compared with a standard strategy using fixed tidal volume and PEEP",[63,64,65,66],"Postoperative Respiratory Failure","Abdominal Surgery","Postoperative Pulmonary Complications","Morality",[68,69,70,71,72],"Mechanical ventilation","Intubation","Mechanical power-guided ventilation","Laparoscopic or non-laparoscopic abdominal surgery","Intensive care unit","NOT_YET_RECRUITING","2026-05-26",{"date":76,"type":77},"2026-06-02","ACTUAL",{"date":79,"type":57},"2026-06-01",{"date":81,"type":57},"2029-01-01",{"name":5,"class":6}]