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临床试验/NCT06493058
NCT06493058已完成不适用

Evaluatıon of the Effectiveness of the Prone Position in Babies Extubed After Congenital Cardio Surgery

Istanbul Medipol University Hospital2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Life Findings Monitoring Form

研究概览

简要总结

The aim of this study was to determine the effect of prone position on vital signs, arterial blood gases and blood values in 0-1 year old infants extubated after congenital heart surgery. The study was a randomised controlled experimental type study.

详细描述

The sample of the study consisted of 40 infants aged 0-1 year who underwent surgery in the Cardiovascular Surgery Intensive Care Unit of a private hospital.Data collection tools consisted of "Data Collection Form", "Vital Signs Follow-up Form", "Arterial Blood Gas Follow-up Form", "Blood Values Follow-up Form" prepared by the researcher in line with the literature information and some measurement data used in the study (arterial blood sample obtained with the blood gas measurement device used in the NICU and blood gas parameters (PaCO2, pH, PaO2, Lac and SaO2) and bedside monitor).

The study was conducted in the Cardiovascular Surgery Intensive Care Unit of a private foundation university hospital. Infants between the ages of 0 and 1 year who had undergone congenital heart surgery and were extubated after surgery, who did not have any congenital anomalies of the lungs in addition to congenital heart disease, who did not have any condition that could affect cardiac, circulatory and respiratory functions or prevent positioning were included in the study. The infants to be included in the study were randomly selected to the control and study groups to avoid bias in the study. Which of the experimental or control groups the infants included in the study would be in was determined by using the address "https://www.calculatorsoup.com".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
1 Day 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • To be between 0-1 years old
  • Having congenital heart surgery
  • Endotracheal intubation has been applied
  • Being extubated after congenital heart surgery
  • Obtaining permission from their parents to participate in the study

排除标准

  • In addition to the diagnosis of congenital heart disease, congenital heart disease of the lungs with any of the anomalies,
  • Position that may affect cardiac, circulatory and respiratory functions or surgical intervention that prevents ECMO (open sternum bone, ECMO support, etc.)
  • Complications developed during the study,
  • Infants whose parents did not agree to participate in the study were included in the study. is not recognised.

结局指标

主要结局

Life Findings Monitoring Form

时间窗: Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation

Pulse values were monitored for 48 hours

次要结局

  • Arterial Blood Gas Monitoring Form(Taken immediately before extubation and at 8, 16, 24, 32 and 48 hours after extubation)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

aysel kokcudogan

Assistant Professor

Istanbul Medipol University Hospital

研究点 (2)

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