"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?"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients who are diagnosed with a serious tracheostomy related airway complication, without associated symptoms reported by caregiver prior to airway endoscopy.
研究概览
简要总结
Study Objective:
This 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.
Study Population:
The 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.
Research Questions:
- To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy?
- How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications?
Methods:
Children 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.
After 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.
The 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.
详细描述
Study Objective This 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.
Background Children with airway obstruction due to congenital malformations, trauma, or chronic respiratory or neuromuscular conditions may require a tracheostomy. The Long-Term Intensive Care Unit (LIVA), part of the Pediatric Perioperative Medicine and Intensive Care (BPMI) at Karolinska University Hospital, has been providing specialized care for children with tracheostomies across Sweden since 1998. The care at LIVA involves assessements by a multidisciplinary team, including pediatricians, ENT specialists, pediatric anesthesiologists, nurses, physiotherapists, dietitians, speech therapists, counselors, and play therapists.
Follow-up at LIVA includes regular multidisciplinary assessments and one to two surveillance airway endoscopies under anesthesia annually, aimed at early detection of airway complications related to the tracheostomy tube. Complications such as granulomas, infections, or bleeding are often asymptomatic but can be potentially life-threatening. There is currently no national or international consensus on the optimal frequency of surveillance endoscopies, and the potential for individualizing surveillance based on risk factors, including the presentation of symptoms, remains unexplored. Given the risks associated with anesthesia, minimizing unnecessary procedures is critical.
Currently, a retrospective study is underway to examine the incidence of tracheostomy-related complications, their correlation with risk and demographic factors, and preoperative symptoms. Preliminary results indicate that 72% of patients experienced at least one tracheostomy-related complication, while only 19% exhibited symptoms prior to surveillance endoscopy according to patient records. Suprastomal granuloma was the most frequent complication observed. Interventions were required for all symptomatic patients and 71% of asymptomatic patients with identified complications. Patients using ventilators and/or cuffed cannulas had a higher incidence of complications compared to those without (88% vs. 61%, p<0.05).
Study Population The 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All 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.
排除标准
- •All 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.
研究组 & 干预措施
Children with tracheostomy undergoing at LIVA
All children under 18 years with tracheostomy undergoing follow-up through the long term intensive care unit LIVA at Karolinska University Hospital Solna, Sweden will be eligible for inclusion. This is a majority of the children living with tracheostomy in Sweden.
结局指标
主要结局
Proportion of patients who are diagnosed with a serious tracheostomy related airway complication, without associated symptoms reported by caregiver prior to airway endoscopy.
时间窗: 2 years
Symtoms prior to surveillance endoscopy are recorded from caregiver reports and from clinical investigation by pediatrician upon admission. Airway complications detected through Surveillance Airway Endoscopy in children with Tracheostomy are recorded. Association between symptoms and identified airway complications is investigated.
Proportion of patients who are diagnosed with a serious tracheostomy related airway complication, without associated symptoms reported by a paediatrician prior to airway endoscopy.
时间窗: 2 years
Symtoms prior to surveillance endoscopy are recorded from caregiver reports and from clinical investigation by pediatrician upon admission. Airway complications detected through Surveillance Airway Endoscopy in children with Tracheostomy are recorded. Association between symptoms and identified airway complications is investigated.
次要结局
- Proportion of patients that was diagnosed with at least one serious tracheostomy related complication during the study period.(2 years)
- Proportion of surveillance airway endoscopies identifying a serious tracheostomy related airway complication without associated symptoms reported by caregiver prior to airway endoscopy.(2 years)
- Proportion of surveillance airway endoscopies identifying a serious tracheostomy related airway complication without associated symptoms reported by pediatrician prior to airway endoscopy .(2 years)
研究者
Ida Engqvist
Medical doctor, Principal Investigator
Karolinska Institutet