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临床试验/NCT06051292
NCT06051292招募中不适用

Decremental Esophageal Catheter Filling Volume Titration For Esophageal Pressure Measurement

Dr. Behcet Uz Children's Hospital8 个研究点 分布在 2 个国家目标入组 27 人开始时间: 2023年9月18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
27
试验地点
8
主要终点
Optimal catheter filling volume

研究概览

简要总结

Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. PL is defined as the difference between alveolar pressure (Palv) and pleural pressure (Ppl). While the direct measurement of Ppl is possible, it poses a risk to tissue integrity. Thus, the primary surrogate for Ppl measurement today is esophageal pressure (Pes).

However, the measurement of Pes is not without challenges. This abstract outlines the pitfalls associated with Pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. These errors can range from underestimation of Pes due to underfilled catheters to overestimation resulting from overfilled catheters.

To address these challenges and optimize Pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. In this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted Mojoli method in the context of pediatric patients. This research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to Pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients between 1 months and 18 years
  • Patients need mechanical ventilation support without modification of ventilation settings within the upcoming 2 hours
  • Informed consent was signed by next of kin
  • Requiring esophageal catheter application

排除标准

  • Patients eligible for extubation or modification of ventilation settings within the upcoming 2 hours
  • Patient included in another interventional study in the last 30 days
  • Patients unable to undergo esophageal catheter insertion due to congenital or acquired pathologies
  • Patient included in another interventional research study under consent
  • Patient already enrolled in the present study in a previous episode of acute respiratory failure

结局指标

主要结局

Optimal catheter filling volume

时间窗: up 1 hour after catheter placement

The clinician will determine the optimal filling volume of the catheter using two distinct methods

次要结局

  • Transpulmonary driving pressure(up 1 hour after catheter placement)
  • Time(up 1 hour after catheter placement)

研究者

发起方
Dr. Behcet Uz Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasan ağın

Professor

Dr. Behcet Uz Children's Hospital

研究点 (8)

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