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临床试验/NCT06140810
NCT06140810招募中不适用

Impact of Atelectasis and Lung Recruitment on RVEDP Measurement in Children Undergoing Cardiac Catheterization for Surveillance Following Orthotropic Heart Transplantation

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater

研究概览

简要总结

Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.

详细描述

Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). Atalectaisis is known to alter intra-thoracic pressures and cardiac loading conditions. What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection. Therefore, the aim of this study is to identify if atelectasis impacts the pressure measurements obtained during cardiac catheterization.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients having undergone orthotropic heart transplantation
  • Patients requiring routine heart catheterization for post-transplant surveillance
  • General anesthesia

排除标准

  • Patient/parental refusal
  • Patients with suspected or known acute rejection
  • Known anti-rejection medication non-compliance
  • Patients within 1 year following heart transplant
  • Home oxygen requirement
  • Previous lung surgery (e.g., lobectomy) other than biopsy
  • Lung transplantation
  • Known pulmonary fibrosis
  • Known pulmonary hypertension (>1/2 systemic)
  • Sedation without the use of an airway device
  • Active respiratory infection -Inability to provide recruitment breaths >25mmHg -Cardiomegaly
  • Recipient/donor size mismatch

结局指标

主要结局

Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater

时间窗: 10 minutes

Change of the right ventricular end diastolic pressure from pre and post recruitment breaths

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Adler MD, MS, FAAP

Associate Professor of Anesthesiology

Baylor College of Medicine

研究点 (1)

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