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临床试验/NCT07233304
NCT07233304招募中不适用

Incidence of Complications From the Alveolar Opening Maneuver in Mechanically Ventilated Children With Respiratory Distress Syndrome

Hospital de Alta Complejidad en Red1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2025年8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
143
试验地点
1
主要终点
Overall incidence of complications related to the alveolar opening maneuver and PEEP titration

研究概览

简要总结

The objective of this research is to analyze the overall incidence of complications associated with a therapeutic maneuver known as alveolar opening and subsequent titration of positive end-expiratory pressure (PEEP) in pediatric patients with acute respiratory distress syndrome (ARDS). These procedures are part of the standard care provided in the Pediatric Intensive Care Unit (PICU) and are used to improve pulmonary oxygenation and respiratory mechanics. Through this study, we aim to gather information that will help improve the safety and effectiveness of these interventions in critically ill patients.

详细描述

Objective

To analyze the overall incidence of complications associated with alveolar opening maneuvers and PEEP in pediatric patients with respiratory distress syndrome.

Materials and Methods

Study setting A prospective cohort study will be conducted between April and September in the Pediatric Intensive Care Unit (PICU) of the Hospital Cuenca Alta Néstor Kirchner (HCANK).

Sample All patients meeting the eligibility criteria will be included. An estimated total of 143 maneuvers involving alveolar opening maneuversand PEEP are to be analyzed, as these procedures are part of the standard care in managing ventilated patients with ARDS and are included in the institutional protocol (see Appendix).

研究设计

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

入排标准

年龄范围
1 Month 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Overall incidence of complications related to the alveolar opening maneuver and PEEP titration

时间窗: 4 hours post-procedure

The number and proportion of patients who develop any adverse event directly associated with the alveolar opening maneuver or PEEP titration within 4 hours after the procedure. Complications may include hemodynamic instability (e.g., hypotension, bradycardia), oxygen desaturation, barotrauma (such as pneumothorax), or cardiac arrhythmias observed during or after the intervention.

次要结局

未报告次要终点

研究者

发起方
Hospital de Alta Complejidad en Red
申办方类型
Other
责任方
Principal Investigator
主要研究者

Belen Castelli

Physical Therapy

Hospital de Alta Complejidad en Red

研究点 (1)

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