跳至主要内容
临床试验/NCT05924087
NCT05924087招募中不适用

Interventional Therapy of Tracheal Stenosis After Percutaneous Tracheotomia

Asklepios Neurological Clinic Bad Salzhausen1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
Decannulation

研究概览

简要总结

After respiratory weaning, decannulation is sought. To do this, the tracheal cannula is first unblocked, so that patients no longer breathe in and out through the cannula, but (at least partially) "passing" the cannula by the natural route. In the presence of tracheal stenosis there is increased breathing effort, possibly restlessness and stridor. This constellation of symptoms suggests the suspicion of tracheal stenosis, so in the next step a tracheoscopy is performed to confirm or exclude tracheal stenosis. In case of symptomatic tracheal stenosis and at least 30-50% stenosis of the trachea (clinical symptoms can be expected from a 30-50% stenosis) then appropriate therapy (here: cryotherapy, other techniques only in exceptional cases) is planned. The goal is to be able to remove the tracheal cannula (long term) after successful therapy, so that patients do not have to be permanently provided with a tracheal cannula. There is no definitive/evidence-based standard therapy for the treatment of tracheal stenosis. Cryotherapy is a gentle therapy that has already been applied and described for the treatment of tracheal stenosis (see above). The examination is performed as part of an analgesic dose, as is routine for a bronchoscopy (in-house SOP). After treatment, a follow-up is planned for about 10 days later.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Tracheal stenosis after percutaneous tracheotomy.

排除标准

  • Pregnant or breast-feeding women of childbearing potential who refuse pregnancy test.
  • lack of consent to participate in the study.
  • surgical tracheotomy.
  • Involvement of the larynx (above the first tracheal brace).

结局指标

主要结局

Decannulation

时间窗: 12 months

Rate of successful decannulations after intervention up to discharge from inpatient treatment.

次要结局

  • Additional treatment(12 months)
  • Reintervention(s)(12 months)
  • Clinical success(12 months)
  • Technical success(12 months)
  • Type of intervention(12 months)

研究者

发起方
Asklepios Neurological Clinic Bad Salzhausen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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