[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658980":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":65,"studyPopulation":54,"armGroups":66,"interventions":81,"overallOfficials":87,"centralContacts":91,"locations":96,"responsibleParty":109,"collaborators":54,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":54,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":54,"enrollmentInfo":122,"targetDuration":54,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":137,"whyStopped":54,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Kayseri City Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"Mean Postoperative Perfusion Index","Perfusion index (PI) is measured noninvasively using a pulse oximeter at postanesthesia care unit (PACU) admission, 5 minutes, and 10 minutes. The primary outcome is the arithmetic mean of these three measurements. PI reflects the ratio of the pulsatile to nonpulsatile component of the photoplethysmographic signal and is used as an indicator of peripheral perfusion.","At PACU admission and 5 and 10 minutes after admission",[14,17,21,24,27,30,33,36,39,43,47,50],{"measure":15,"description":16,"timeFrame":12},"Postoperative Pleth Variability Index","Pleth variability index (PVI) is measured noninvasively using a pulse oximeter at PACU admission, 5 minutes, and 10 minutes to compare early postoperative changes among the three study groups.",{"measure":18,"description":19,"timeFrame":20},"Postoperative Arterial Lactate","Arterial lactate concentration, reported in mmol\u002FL, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission. No additional arterial sampling is performed solely for this study.","At postanesthesia care unit (PACU) admission (0 minutes)",{"measure":22,"description":23,"timeFrame":20},"Postoperative Arterial pH","Arterial pH obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.",{"measure":25,"description":26,"timeFrame":20},"Postoperative Arterial Carbon Dioxide Partial Pressure","Arterial carbon dioxide partial pressure (PaCO2), reported in mmHg, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.",{"measure":28,"description":29,"timeFrame":20},"Postoperative Arterial Oxygen Partial Pressure","Arterial oxygen partial pressure (PaO2), reported in mmHg, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.",{"measure":31,"description":32,"timeFrame":20},"Postoperative Arterial Bicarbonate","Arterial bicarbonate concentration (HCO3), reported in mmol\u002FL, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.",{"measure":34,"description":35,"timeFrame":20},"Postoperative Arterial Base Excess","Arterial base excess (BE), reported in mmol\u002FL, obtained from routine arterial blood gas analysis at postanesthesia care unit (PACU) admission.",{"measure":37,"description":38,"timeFrame":20},"Postoperative Hemoglobin","Hemoglobin concentration, reported in g\u002FdL, recorded from routine blood gas testing at postanesthesia care unit (PACU) admission.",{"measure":40,"description":41,"timeFrame":42},"Postoperative Shivering","Number of participants with postoperative shivering. Shivering is recorded as present or absent during the first 30 minutes after postanesthesia care unit (PACU) admission.","From PACU admission through the first 30 minutes after admission",{"measure":44,"description":45,"timeFrame":46},"Time to Initiation of Oral Feeding","Time from the end of surgery to the first initiation of oral feeding, recorded in hours. Participants are followed for initiation of oral feeding for up to 14 days after surgery.","From the end of surgery until initiation of oral feeding, assessed up to 14 days after surgery",{"measure":48,"description":49,"timeFrame":12},"Postoperative Pain Score","Pain intensity assessed using a visual analogue scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores are recorded at PACU admission, 5 minutes, and 10 minutes. Higher scores indicate greater pain.",{"measure":51,"description":52,"timeFrame":53},"Wound Infection Within 14 Days After Surgery","Number of participants who develop a wound infection during the 14-day period following surgery. Wound infection is recorded as present or absent.","Within 14 days after surgery",null,{"allocation":56,"interventionModel":57,"interventionModelDescription":58,"primaryPurpose":59,"observationalModel":54,"timePerspective":54,"maskingInfo":60},"RANDOMIZED","PARALLEL","Three parallel groups randomized 1:1:1 to 10 minutes of prewarming, 30 minutes of prewarming, or no active prewarming. All groups receive intraoperative warming. A computer-generated randomization list and sequentially numbered, sealed opaque envelopes are used for allocation concealment.","SUPPORTIVE_CARE",{"masking":61,"maskingDescription":62,"whoMasked":63},"SINGLE","The outcome assessor is blinded to randomized group assignment.",[64],"OUTCOMES_ASSESSOR","This prospective, single-center, randomized controlled study will be conducted by the Department of Anesthesiology and Reanimation at Kayseri City Hospital. Adults undergoing elective colon resection under general anesthesia will be randomized in a 1:1:1 ratio using a computer-generated randomization list. Allocation will be concealed in sequentially numbered, sealed opaque envelopes opened before the preoperative intervention. The planned sample size is 108 participants, with 36 participants per group.\n\nActive prewarming will be applied in the preoperative preparation area using a forced-air warming system covering the upper and lower body. Device settings will follow manufacturer recommendations and institutional clinical standards. The two prewarming groups will receive 10 or 30 minutes of active warming before anesthesia. The control group will receive routine preoperative care without active prewarming. All groups will receive intraoperative warming and standard anesthesia monitoring and management.\n\nPerfusion index and pleth variability index will be measured noninvasively using a pulse oximeter at postanesthesia care unit (PACU) admission and at 5 and 10 minutes. The primary analysis will compare the arithmetic mean of the three postoperative perfusion index measurements between groups. Arterial blood gas and lactate results will be obtained from routine clinical testing without an additional invasive procedure for research. Demographic characteristics, ASA physical status, anesthesia and surgical duration, perioperative temperature, and relevant intraoperative clinical variables will be recorded.\n\nThe primary outcome will be compared using one-way analysis of variance when distributional assumptions are met, or the Kruskal-Wallis test otherwise, with appropriate post-hoc comparisons. Repeated perfusion index measurements will also be examined for group and time effects. Secondary continuous and categorical outcomes will be analyzed with methods appropriate to their distributions. Associations of perfusion index with lactate, blood gas parameters, and pain scores will be examined using Pearson or Spearman correlation. Statistical significance will be set at p \\\u003C 0.05.\n\nThe outcome assessor will be blinded to group assignment. Postoperative pain will be assessed using a 0-10 visual analogue scale at PACU admission and at 5 and 10 minutes. Wound infection will be assessed during the 14-day period following surgery.",[67,73,77],{"label":68,"type":69,"description":70,"interventionNames":71},"10-Minute Prewarming","EXPERIMENTAL","Participants receive 10 minutes of active forced-air warming in the preoperative preparation area before induction of general anesthesia. Warming covers the upper and lower body, with settings following manufacturer recommendations and institutional standards. All participants receive routine intraoperative warming as standard care. Standard anesthetic care is provided in all three groups.",[72],"Device: Preoperative Forced-Air Warming",{"label":74,"type":69,"description":75,"interventionNames":76},"30-Minute Prewarming","Participants receive 30 minutes of active forced-air warming in the preoperative preparation area before induction of general anesthesia. Warming covers the upper and lower body, with settings following manufacturer recommendations and institutional standards. All participants receive routine intraoperative warming as standard care. Standard anesthetic care is provided in all three groups.",[72],{"label":78,"type":79,"description":80,"interventionNames":54},"Control: No Prewarming","NO_INTERVENTION","Participants receive routine preoperative care without active prewarming before induction of general anesthesia. All participants receive routine intraoperative warming as standard care. Standard anesthetic care is provided in all three groups.",[82],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":54},"DEVICE","Preoperative Forced-Air Warming","Active warming using a forced-air warming system in the preoperative preparation area before general anesthesia. The upper and lower body are warmed for 10 or 30 minutes according to randomized group assignment. Device temperature settings follow manufacturer recommendations and institutional clinical standards.",[68,74],[88],{"name":89,"affiliation":5,"role":90},"Çiğdem Ünal Kantekin, MD","PRINCIPAL_INVESTIGATOR",[92],{"name":89,"role":93,"phone":94,"phoneExt":54,"email":95},"CONTACT","+90 505 443 3056","drcgdm@hotmail.com",[97],{"facility":5,"status":54,"city":98,"state":54,"zip":99,"country":100,"countryCode":54,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Kayseri","38080","Turkey (Türkiye)",{"type":102,"coordinates":103},"Point",[104,105],35.48528,38.73222,{"lat":105,"lon":104},[108],{"name":89,"role":93,"phone":94,"phoneExt":54,"email":95},{"type":110,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"SPONSOR_INVESTIGATOR","Çiğdem Ünal Kantekin","Associate Professor of Anesthesiology and Reanimation","100658980","effect-of-prewarming-duration-on-blood-flow-after-colon-resection-surgery-100658980",false,"NCT07857538","Effect of Prewarming Duration on Blood Flow After Colon Resection Surgery","Evaluation of the Effect of Preoperative Prewarming Duration on Postoperative Perfusion Index in Patients Undergoing Colon Resection Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older.\n* Scheduled for elective colon resection surgery under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Willing to participate and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Age younger than 18 years.\n* Emergency surgery.\n* Severe vascular disease that may affect peripheral circulation, such as advanced peripheral arterial disease.\n* Severe cardiovascular instability.\n* Fever (\\>38 degrees Celsius) or hypothermia (\\\u003C36 degrees Celsius) before surgery.\n* Severe anemia (hemoglobin \\\u003C8 g\u002FdL).\n* Requirement for vasopressor or inotropic support.\n* A condition in the measurement limb that prevents perfusion index measurement, such as severe peripheral edema, an intravenous line, or involvement of the surgical field.\n* Refusal to participate.","ALL","18 Years",{"count":123,"type":124},108,"ESTIMATED","INTERVENTIONAL",[127],"NA","This study will examine whether warming patients before colon resection surgery improves blood flow in the fingers during early recovery from general anesthesia. It will also compare two warming durations. A total of 108 adults scheduled for elective colon resection surgery at Kayseri City Hospital will be assigned by chance to one of three groups: 10 minutes of warming before anesthesia, 30 minutes of warming before anesthesia, or no active warming before anesthesia. All three groups will receive warming during surgery as part of routine care.\n\nWarming will be provided using a forced-air warming system. After surgery, a sensor placed on a finger will measure the perfusion index, a noninvasive indicator of blood flow, on arrival in the recovery unit and 5 and 10 minutes later. The main comparison will use the average of these three measurements. The researchers will also assess other circulation measurements, routine blood gas and lactate results, shivering, pain, the time until oral feeding begins, and wound infection during the 14 days after surgery.",[130],"Perioperative Hypothermia",[132,133,134,135,136],"Prewarming","Colon resection","Perfusion index","Pleth variability index","Forced-air warming","NOT_YET_RECRUITING","2026-09-30",{"date":140,"type":141},"2026-10-05","ACTUAL",{"date":143,"type":124},"2026-10-15",{"date":145,"type":124},"2027-03-15",{"name":111,"class":6},1]