[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603793":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":48,"responsibleParty":59,"collaborators":28,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":28,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":28,"enrollmentInfo":69,"targetDuration":28,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":28,"overallStatus":80,"whyStopped":28,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"HSFM + Manual Turning (Standard Care)","ACTIVE_COMPARATOR","ICU patients are placed on a high-specification foam mattress with scheduled manual repositioning per unit protocol (target every 2 hours using pillows). All other care follows unit protocols.",[13,14],"Device: HSFM","Other: Manual Turning (with pillows, per protocol)",{"label":16,"type":17,"description":18,"interventionNames":19},"TAPAM (Turn-Assist Alternating Pressure Air Mattress with Positioning Pillows)","EXPERIMENTAL","ICU patients receive a turn-assist alternating pressure air mattress that integrates pressure redistribution with automated lateral turning at preset intervals with positioning pillows. The mattress is used continuously during the ICU stay. All other care follows unit protocols.",[20,21],"Device: TAPAM","Other: Positioning Pillows",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","TAPAM","Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.",[16],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"HSFM","Device: High-Specification Foam Mattress (HSFM) Standard ICU care support surface.",[9],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Manual Turning (with pillows, per protocol)","Nurse-performed scheduled manual turning (target every 2 hours, with pillows).",[9],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Positioning Pillows","Supplemental pillows used to support and maintain patient position.",[16],[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Wei Ling Hsuai, PhD","CONTACT","+886-23123456","263141","hsiao0603@ntuh.gov.tw",[49],{"facility":5,"status":28,"city":50,"state":28,"zip":28,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":28},"Taipei","Taiwan","TW",{"type":54,"coordinates":55},"Point",[56,57],121.52639,25.05306,{"lat":57,"lon":56},{"type":60,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100603793","turnova-the-clinical-efficacy-manpower-reduction-and-cost-effectiveness-of-turn-assist-alternating-pressure-air-mattresses-for-pressure-injury-prevention-in-the-icu-100603793",false,"NCT07141134","Turnova: The Clinical Efficacy, Manpower Reduction, and Cost-Effectiveness of Turn-Assist Alternating Pressure Air Mattresses for Pressure Injury Prevention in the ICU","Inclusion Criteria:\n\n* Adult patients (≥18 years old) admitted to medical or surgical intensive care units (ICUs).\n* Admission time between 08:00 and 23:00.\n* Clinical condition requires ICU-level care.\n\nExclusion Criteria:\n\n* Repeat ICU admission during the study period.\n* Unstable spinal fracture.\n* Receiving cervical or skeletal traction.\n* Body weight \\>180 kg (exceeds mattress weight limit).\n* Declines participation in the study.","ALL","18 Years",{"count":70,"type":71},236,"ESTIMATED","INTERVENTIONAL",[74],"NA","Pressure injuries are common in intensive care unit (ICU) patients who cannot reposition themselves. International guidelines recommend using support surfaces to redistribute pressure and regular turning to prevent these injuries. In Taiwan, high-specification foam mattresses (HSFM) with manual turning remain the standard, but frequent repositioning is labor-intensive and challenging in settings with limited nursing staff. The Turn-Assist Alternating Pressure Air Mattress (TAPAM) integrates pressure redistribution with automated lateral turning, potentially reducing nursing workload while maintaining preventive effectiveness. This study will compare TAPAM with HSFM plus manual turning in ICU patients, evaluating manpower requirements, time spent, perceived effort, and clinical outcomes. A cost-effectiveness and cost-benefit analysis will be conducted to assess the overall value of TAPAM for pressure injury prevention in high-risk ICU populations.",[77,78,79],"Critical Care, Intensive Care","Nursing Workload","Cost Analysis","NOT_YET_RECRUITING","2025-09-02",{"date":83,"type":84},"2025-09-08","ACTUAL",{"date":83,"type":71},{"date":87,"type":71},"2026-07-30",{"name":5,"class":6},1]