[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tracheostomy-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tracheostomy-complications":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100585737","complications-related-to-the-anaesthesia-during-airway-endoscopy-in-children-with-tracheostomy-100585737",false,"NCT06906263","Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.","All patients:\n\nunder the age of 18 years with tracheostomy undergoing surveillance airway endoscopy approved for anesthesia\n\nwill be included within the time frame of the study (3 years). Patients may be included multiple times during the study period.\n\nExclusion Criteria:\n\nPatients will be excluded from the study if the airway endoscopy is a non-elective emergency procedure.\n\nPatients undergoing concurrent major surgery during the same session will be included in the study but excluded from analysis of postoperative symptoms (secondary outcome measure). This is because postoperative well-being cannot be reliably attributed to the airway endoscopy alone when major surgery is performed simultaneously.\n\nThe same patient may be eligible for inclusion at multiple time points during the inclusion period if subject to subsequent airway endoscopies that meet the inclusion criteria.","ALL","18 Years",{"count":18,"type":19},80,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to investigate the incidence of severe anaesthesiologic complications during anaesthesia in children with tracheostomy undergoing surveillance airway endoscopy. The main question it aims to answer is how common severe anaesteshiologic complications are in these patients and investigate if there is an association between severe anaesthesiologic complications and patient related factors.\n\nPrimary outcome: The incidence of severe anaesthesiologic complications in children with tracheostomy undergoing surveillance airway endoscopy.\n\nSecondary outcome: The association between severe anaesthesiologic complications and patient related factors: age at tracheostomy, age at surveillance endoscopy, ventilator dependence, current and previously diagnosed tracheostomy related airway complications.\n\nAll children under 18 yrs. of age with a tracheostomy accepted for general anaesthesia undergoing surveillance airway endoscopy at the Long term Intensive Care unit at Karolinska University Hospital Stockholm Sweden will be eligable for inclusion. The anaesthesia will be conducted according to current practise and complications will recorded by the anaesthesiologist in charge. Participants may only be included several times during the study period.",[23,24,25],"Anesthesia Complication","Tracheostomy Complications","Children Receiving General Anesthesia",[27,28,29,30],"Tracheostomy","Pediatric","Anesthesia complication","general anesthesia","RECRUITING","2026-03-17",{"date":34,"type":35},"2026-03-20","ACTUAL",{"date":37,"type":35},"2025-03-31",{"date":39,"type":19},"2028-03-31",{"name":41,"class":42},"Karolinska Institutet","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":50,"targetDuration":52,"studyType":20,"phases":4,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100602285","airway-complications-in-pediatric-patients-with-tracheostomies-to-what-extent-can-symptoms-identified-by-caregivers-or-pediatricians-serve-as-predictors-for-airway-complications-confirmed-through-surveillance-endoscopy-100602285","NCT07121517","\"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?\"","Inclusion Criteria:\n\nAll children, with tracheostomy, under the age of 18, undergoing scheduled surveillance airway endoscopy in anaesthesia as part of their regular follow-up at the Long term Intensive Care unit (LIVA) at Karolinska University Hospital are eligible for inclusion. Patients may be included several times during the study period.\n\nExclusion criteria:\n\nAll patients undergoing airway endoscopy that is not part of the surveillance airway endoscopy program will be excluded. Thus, emergency endoscopies are not included in this study.",{"count":51,"type":19},100,"2 Years","Study Objective:\n\nThis observational study aims to prospectively investigate to what extent tracheostomy-related complications in children are asymptomatic or associated with symptoms when detected through surveillance airway endoscopy. We also aim at investigating how reliable caregiver reports and investigations by pediatriscians are in identifying symptoms associated with severe tracheostomy-related airway complications.\n\nStudy Population:\n\nThe study population comprises children under 18 years of age undergoing follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Stockholm, Sweden.\n\nResearch Questions:\n\n1. To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy?\n2. How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications?\n\nMethods:\n\nChildren scheduled for surveillance airway endoscopy are admitted to LIVA. Upon admission, the caregiver is asked to complete a short questionnaire regarding symptoms that may indicate a tracheostomy-related complication.\n\nAfter the questionnaire has been completed, the child will be examined by the responsible paediatrician, with the aim of identifying any signs or symptoms that could indicate an airway complication. The examination includes physical examination and medical history conducted according to a predefined protocol.\n\nThe airway endoscopy is performed by an ENT surgeon who has not examined the patient beforehand and is not informed of the caregiver's responses nor the result of the examination by the pediatrician. However, there is no strict protocol in place to blind the surgeon to any visibly apparent symptoms or to information that may be spontaneously reported by the caregiver or paediatrician.",[55,56,57,24,27,58],"Surveillance","Endoscopy","Tracheostomy Complication","Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter",[60,61,62,63,64],"surveillance","endoscopy","pediatric","intensive care unit","tracheostomy complication","2026-02-12",{"date":67,"type":35},"2026-02-17",{"date":69,"type":35},"2025-09-01",{"date":71,"type":19},"2027-08-31",{"name":41,"class":42}]