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临床试验/NCT04454294
NCT04454294已完成不适用

Determining the Effect of Two Different Methods on Bleeding, Vital Signs and Oxygen Saturation in Children to Maintain Drain Patency After Cardiac Surgery

Acibadem University2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2018年7月28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
90
试验地点
2
主要终点
Body temperature

研究概览

简要总结

In this study, it was aimed to determine the effect of the use of milking and sucking methods on bleeding amount, vital signs and oxygen saturation in children with chest and mediastinal drains after cardiac surgery.

详细描述

The patient admitted to the post-operative Cardiovascular Surgery Intensive Care Units primarily meets two nurses and is responsible for the arrangement of medical equipment, monitoring, monitoring, maintaining, recording, and performing the necessary treatments. Then the nurse positions the drain after checking the drain connections, checks the level of the drain and records it in the nurse follow-up note. Then, the method to be used in maintaining the drain opening is decided in cooperation with the physician.

Three different methods are currently used in the unit. The first method; There is no application in maintaining the drain opening, but if there are necessary medical indications such as clot formation, blood accumulation in the drainage connections, lack of drainage, this group is intervened by milking method. In our study, this group will be taken as a control group, there will be a situation that requires intervention in the first 6 hours, and if the milking method is used, it will be excluded from the sample.

The second method used to maintain the drain opening is the suction method. In this study, this group will be taken as the first experimental group. The suction method is a continuous use until the patient's drainage requirement and the physician's request is terminated by ensuring that the pressure is between 5 and 15 kPa (kilopascals) or 10-20 cm H20 after the appropriate negative pressure tracking system of the patient, who is accepted with intensive care under water drainage system, is established. system.

The third method is milking. In our study, this group will be taken as the 2nd experimental group. In the milking method, the process starts from the area close to the drain entry point. The latex tube is folded into 12 cm long pieces and gripped with two hands. The nurse repeats the process 3 times by compressing the parts gripped by the hand. This process is then used at intervals every hour to repeat the distal part.

After the applications related to the method to be used are performed, the patient's vital signs, Sp02 and bleeding amount are generally monitored every hour.

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
None

入排标准

年龄范围
1 Month 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Parents / legal guardian agree to participate in the study and sign the informed consent form,
  • Having undergone congenital cardivascular surgery for the first time,
  • Chest and / or mediastinal drain after cardiac surgery,
  • Without secondary congenital anomaly and chronic disease,
  • No neurological symptoms,
  • No sepsis,
  • 1 month - 1 year old age group,
  • Anticoagulant use after surgery and during research,

排除标准

  • Receiving extra corporal membrane oxygenation support,
  • Sternum admitted to open intensive care,
  • Receiving intraaortic balloon pump support,
  • Reoperative
  • Complicated cases with bleeding diathesis and thought to be highly drained

结局指标

主要结局

Body temperature

时间窗: 6 hours after surgery

This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary. The data for each group will be collected before and after the procedure for 6 hours after surgery

Heart rate

时间窗: 6 hours after surgery

This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery

Oxygen saturation

时间窗: 6 hours after surgery

This outcome obtained with patient monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery

Respiratory rate

时间窗: 6 hours after surgery

This outcome will be considered as one of the vital signs. Heart rate measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery

Blood pressure

时间窗: 6 hours after surgery

This outcome contains both systolic and diastolic blood pressure. Blood pressure measurement will be evaluated via monitor. The data for each group will be collected before and after the procedure for 6 hours after surgery

Bleeding amount

时间窗: 6 hours after surgery

This outcome obtained with patient drain. The data for each group will be collected before and after the procedure for 6 hours after surgery

次要结局

未报告次要终点

研究者

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

Zehra Kan Onturk

Assistant Professor

Acibadem University

研究点 (2)

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