[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563704":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":22,"studyPopulation":23,"armGroups":24,"interventions":35,"overallOfficials":46,"centralContacts":51,"locations":56,"responsibleParty":67,"collaborators":18,"id":69,"slug":18,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":18,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":18,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":18,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Bakirkoy Dr. Sadi Konuk Research and Training Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"postoperative pulmonary complications","Our primary aim was to compare the presence of postoperative pulmonary complications. The presence of these pulmonary complications will be compared between preoperative chest X-ray and postoperative day 1 X-ray imaging in patients with Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score below 44.","24 hours postoperatively",[14],{"measure":15,"description":16,"timeFrame":17},"intraoperative haemodynamic parameters","Our secondary aim was to evaluate intraoperative haemodynamic parameter(mean arterial pressure) in alveolar recruitment strategy in lung-protective ventilation.","intraoperatively",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"COHORT","PROSPECTIVE","In the gynaecological oncology clinic of our hospital, open major surgeries for endometrial or ovarian cancer are performed very frequently. In these surgeries, the abdomen is open to the operating theatre environment and the lithotomy and trendelenburg position may have negative consequences on the respiratory system in patients. Intraoperative lung protective ventilation strategies are recommended to reduce postoperative pulmonary complications. In the lung protective ventilation strategy, positive end-expiratory pressure is recommended in addition to 6-8 ml\u002Fkg tidal volume according to ideal body weight. In addition, alveolar recruitment strategy can be applied. For this purpose, the investigators planned to evaluate the effect of alveolar recruitment strategy on postoperative pulmonary complications in patients who underwent lung protective ventilation in major open gynaecooncological surgeries. Our secondary aim was to evaluate perioperative haemodynamics, respiratory mechanics, inpatient length of stay.","As a result of power analysis, the minimum sample size was determined as 16 for each group with an effect size of 1.2, a 5% margin of error and 95% power. We planned 20 patients for each group due to data losses and deficiencies.",[25,31],{"label":26,"type":18,"description":27,"interventionNames":28},"Group 1, lung protective ventilation with alveolar recruitment","In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml\u002Fkg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, the number of breaths will be adjusted and ventilation will be started. After 10 minutes of ventilation, alveolar recruitment manoeuvre will be started by switching the mechanical ventilator to pressure controlled ventilation (PCV) mode in patients in whom alveolar recruitment strategy (ARS) will be applied. PEEP will be 30 cmHg with 2 unit increases in PEEP for 2 minutes each ventilation will be applied until PEEP reaches 20. When the mean arterial pressure decreases more than 20%, recruitment will be terminated. PEEP will be restored when PEEP 20 is reached. Mechanical ventilation will be switched to VCV mode.",[29,30],"Device: alveolar recruitment strategy applied group","Drug: group without alveolar recruitment strategy",{"label":32,"type":18,"description":33,"interventionNames":34},"Group 2, lung protective ventilation without alveolar recruitment","In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml\u002Fkg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, ventilation will be provided by adjusting the number of breaths.",[29,30],[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":18},"DEVICE","alveolar recruitment strategy applied group","the effect of alveolar recruitment strategy on the mechanical parameters of the patients",[26,32],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":18},"DRUG","group without alveolar recruitment strategy","effect on mechanical parameters of patients without alveolar recruitment strategy",[26,32],[47],{"name":48,"affiliation":49,"role":50},"Duygu Akyol","Başakşehir Çam & Sakura City Hospital","PRINCIPAL_INVESTIGATOR",[52],{"name":48,"role":53,"phone":54,"phoneExt":18,"email":55},"CONTACT","+905447616034","dr.duyguaygun@gmail.com",[57],{"facility":48,"status":58,"city":59,"state":18,"zip":18,"country":60,"countryCode":18,"cosmosGeoPoint":61,"geoPoint":66,"contacts":18},"RECRUITING","Istanbul","Turkey (Türkiye)",{"type":62,"coordinates":63},"Point",[64,65],28.94966,41.01384,{"lat":65,"lon":64},{"type":50,"investigatorFullName":48,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Principal Investigator","100563704",false,"NCT06619626","Alveolar Recruitment in Obese Patients in Major Gynaecological Cancer Surgery","The Effect of Alveolar Recruitment on Perioperative Outcomes in Obese Patients in Major Gynaecological Cancer Surgery: a Prospective Randomised Controlled Trial","Inclusion Criteria:\n\n* Patients with ASAII and III\n* BMI\\>30 kg\u002Fm2 ,\\\u003C40 kg\u002Fm2\n* Patients with an ARISCAT risk score of 26-44\n\nExclusion Criteria:\n\n* Patients with an Assessment of Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score \\> 44\n* BMI \\> 40 kg\u002Fm2 patients","FEMALE","18 Years",{"count":78,"type":79},40,"ESTIMATED","OBSERVATIONAL","In this study, the investigators planned to evaluate the effect of alveolar recruitment strategy primarily on postoperative pulmonary complications in obese patients undergoing lung protective ventilation in major open gynaeco-oncological surgeries. Our other aim was to evaluate perioperative haemodynamics, respiratory mechanics,inpatient length of stay.",[83],"Gynecologic Cancers",[85,86,87],"gynecologic cancer surgery","alveolar recruitment strategy","positive end-expiratory pressure","2024-10-05",{"date":90,"type":91},"2024-10-09","ACTUAL",{"date":93,"type":91},"2024-01-01",{"date":95,"type":79},"2024-11-30",{"name":5,"class":6},1]