Nctid:
NCT06615271
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003668", "term"=>"Pressure Ulcer"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}, {"id"=>"D000071576", "term"=>"Crush Injuries"}], "ancestors"=>[{"id"=>"D000012883", "term"=>"Skin Ulcer"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M834", "name"=>"Crush Injuries", "asFound"=>"Pressure Injury", "relevance"=>"HIGH"}, {"id"=>"M17206", "name"=>"Ulcer", "relevance"=>"LOW"}, {"id"=>"M6870", "name"=>"Pressure Ulcer", "asFound"=>"Pressure Injury", "relevance"=>"HIGH"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "asFound"=>"Injury", "relevance"=>"HIGH"}, {"id"=>"M15686", "name"=>"Skin Ulcer", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>170}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-12-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2023-10-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Incidence of pressure injuries in the neurosurgery, in surgical interventions lasting more than 3 hours. It will be measured by direct observation of the wound, from the time the patient enters the operating room until the next 72 hours thereafter.", "timeFrame"=>"72 hours"}], "secondaryOutcomes"=>[{"measure"=>"Locations of the pressure injuries concerning to the different types of positioning.It will be measured by direct observation of the wound, from the time the patient enters the operating room until the next 72 hours thereafter.", "timeFrame"=>"72 hours"}, {"measure"=>"the risk factors that contribute to the appearance of pressure injurieS. It will be measured by direct observation of the wound, from the time the patient enters the operating room until the next 72 hours thereafter.", "timeFrame"=>"72 hours"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["injuries", "surgical", "neurosurgery", "prevention", "nurse", "clinical practice"], "conditions"=>["PRESSURE INJURIES"]}, "descriptionModule"=>{"briefSummary"=>"This research project is a descriptive, longitudinal prospective observational study in the HUMV neurosurgery operating rooms. The patients included will be adults 18 years old or older, who will be scheduled for surgery by the Neurosurgery service. Those who meet the selection criteria determined for this study will be chosen consecutively and will be followed from the immediate preoperative moment until 72 hours after the end of the surgery. Data collection shall be carried out by direct observation and immersion in clinical records of patients who have signed the informed consent. The study will be carried out in 4 phases: immediate preoperative, intraoperative, immediate postoperative and late postoperative, recording the data using various measuring instruments, and a record sheet. Finally, the cumulative incidence of LPPs developed in the perioperative environment will be calculated and a statistical analysis will be performed.", "detailedDescription"=>"The surgical area represents a scenario to be taken into account in the prevention of pressure injuries (LPP), being an essential and priority aspect in these injuries, demonstrating that more than 95% of them are avoidable. The latest national incidence study conducted in 2019, shows an incidence figure of 14% in post-surgical units and resuscitation, approaching the US between 12% and 66% of incidence in surgical patients, being considered a sentinel event, considering a medical cost of more than $26.8 billion.\n\nThe project will be developed from June 2023 to May 2025. It has been approved by the Research Ethics Committee of Cantabria, and the start of the study is scheduled for October 2023. Afterwards, the analysis of the data and the interpretation of the results will be done, ending with a final article to be disseminated and disseminated in magazines, congresses or national and international talks.\n\nSurgical patients present specific risk factors, leading to the appearance of LPP. Therefore, this study aims to obtain some initial data to create a clinical care guide and prevention protocols updated and specific for clinical practice."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"adult patients over 18 years, women and men.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients who understand and sign the informed consent.\n* Adult patients of both sexes who will undergo a schedule surgery of more than 3 hours, by the service of neurosurgery of the University Hospital Marqués of Valdecilla (HUMV), between 2023 and 2024.\n* Patients positioned in prone, supine, lateral and beach chair/sitting.\n* Surgeries susceptible to bladder catheterisation with body temperature measurement.\n* Patients admitted into neurosurgery ward, the day before surgery.\n\nExclusion Criteria:\n\n* Patients who do not sign informed consent.\n* Patients with visible pressure injurie present before surgery.\n* Patients with cognitive disorder or written and oral knowledge difficulty.\n* Patients who reject the operation.\n* Patients not operated due to lack of prior time.\n* Patients who do not receive vasoactive drugs such as ephedrine, phenylephrine and noradrenaline.\n* Patients whose postoperative period is performed in the ICU.\n* Patients whose surgical intervention, despite the initial estimate of the surgical time, lasted less than 3 hours.\n* Patients admitted \\>24 hours prior the surgery."}, "identificationModule"=>{"nctId"=>"NCT06615271", "acronym"=>"UPS", "briefTitle"=>"Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.", "organization"=>{"class"=>"OTHER", "fullName"=>"Instituto de Investigación Marqués de Valdecilla"}, "officialTitle"=>"Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.", "orgStudyIdInfo"=>{"id"=>"UPS"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients who have undergone neurosurgery form more than 3 hours.", "description"=>"The ones who perform the selection criteria determined for this study will be chosen consecutively, and a follow-up will be carried out from the immediate preoperative moment until 72 hours once the surgery has finished.", "interventionNames"=>["Procedure: Neurosurgery"]}], "interventions"=>[{"name"=>"Neurosurgery", "type"=>"PROCEDURE", "description"=>"Patients who have undergone neurosurgery form more than 3 hours.", "armGroupLabels"=>["Patients who have undergone neurosurgery form more than 3 hours."]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"39008", "city"=>"Santander", "state"=>"Cantabria", "status"=>"NOT_YET_RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"maria perez sastre", "role"=>"CONTACT", "email"=>"mariaperezsastre95@gmail.com"}, {"name"=>"lucia lavin alconero", "role"=>"CONTACT", "email"=>"eclinicos5@idival.org"}], "facility"=>"Hospital Universitario Marques de Valdecilla", "geoPoint"=>{"lat"=>43.46472, "lon"=>-3.80444}}, {"zip"=>"39008", "city"=>"Santander", "status"=>"RECRUITING", "country"=>"Spain", "facility"=>"Hospital universitario marques de valdecilla", "geoPoint"=>{"lat"=>43.46472, "lon"=>-3.80444}}], "centralContacts"=>[{"name"=>"maria perez sastre", "role"=>"CONTACT", "email"=>"mariaperezsastre95@gmail.com", "phone"=>"+34942203389"}, {"name"=>"Lucía Lavin", "role"=>"CONTACT", "email"=>"eclinicos5@idival.org", "phone"=>"+34942203389"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Instituto de Investigación Marqués de Valdecilla", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
