跳至主要内容
临床试验/CTRI/2023/06/054248
CTRI/2023/06/054248招募中Unknown

Ambispective cohort study to evaluate the effect of Supraglottoplasty on Tracheomalacia in pediatric patients with Congenital Laryngotracheomalacia

All India Institute of Medical Sciences, New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Age group of 1 month - 5 years with noisy breathing/stridor
  • Endoscopic confirmation of co-existing laryngomalacia and tracheomalacia
  • More than 50% collapse in the trachea during expiration / inspiration on dynamic flexible bronchoscopy.
  • Any degree of laryngomalacia
  • Presence of at least two of the following clinical features
  • 1. Failure to thrive (z-score of weight for age less than 2)
  • 2. 3 or more hospitalizations for LTM related complications
  • 3. Severe respiratory distress necessitating endotracheal intubation
  • 4. Episodes of bradycardia/ cyanosis/ apnea due to Laryngotracheomalacia
  • 5. SPO2 less than 90% at room air without the support of O2/ CPAP
  • 6. Previously tracheostomized for LTM with failed attempts at decannulation
  • Parents giving informed written consent to participate in the study.

排除标准

  • Laryngeal/ tracheal narrowing due to external compression
  • Patients not consenting for surgery
  • Severe neurological/ cardiac comorbidities / poor pulmonary reserve

研究者

发起方
All India Institute of Medical Sciences, New Delhi

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