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临床试验/NCT05393128
NCT05393128已完成不适用

The Effect of Different Positions in Children After Cardiac Surgery On Vital Signs And Oxygen Saturation

Acibadem University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年3月17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
78
试验地点
2
主要终点
Change in Oxygen Saturation

研究概览

简要总结

The objective of this study to determine the effects of giving right lateral, left lateral and supine positions on vital signs and oxygen saturation in children after cardiac surgery.

详细描述

Convenient ventilation management after pediatric cardiac surgery and the positioning of the patient helps to reduce the maximum intrathoracic pressure and venous stasis of the trunk and upper extremities that facilitates the drainage of the blood in the lungs. Due to the fact that the Pre-operative and post-operative management has tremendously changed for the last years, more detailed and up-to-date information is required related to the effect of the body position on the changes of the lung capacities and the pulmonary function. Based on this reason, this research was designed to determine the effect of three different positions as a randomized controlled prospective study.

In case the unit does not contain as routine any obstacle for position (unilateral oedema, ciculation disorder in the extremities, non-bilateral pulmonary atelectasis or dense infiltration, patients who cannot be administered dormicum or fentaver) right lateral, left lateral and supine positions are given. First positioning; also in routine, the standart position given to the first patients is supine position. The patient is first placed supine. Then his arms and legs are supported with support pillows. Transducer level and cuff pressure are controlled, SpO2 probe, ECG probes are controlled. If there's CVK connection, if there isn't any arterial connection, the cuff is controlled and in order to avoid heat loss the patient is covered after controling the body temperature and the position is completed.

In positioning, the 2nd method is right lateral positioning. In this positioning, the patient bed is straightened. Later on, the patient's SpO2 probe, ECG probes, CVK, arterial and cuff connections are once again moved to the right side of the patient and moved from below the patient's body without contact with the body in order to ensure the connections. Then, the patient is turned to right side with angle of 60 or 90 degrees and back is supported with a pillow from the neck to his sacrum, between the legs is also supported with a pillow. Afterwards, the patient's head is elevated with 45 to 60 degrees. Body temperature is controlled. The body is covered in order to avoid temperature loss and position is completed.

The third position that is used is left lateral position. In this positioning, the patient bed is straightened. Then, the patient's SpO2 probe, ECG probe, CVK, artery and cuff connections are transferred to the left side and the connections are made by passing the connections from below the pillow of the patient without touching the body. Later on, The patient is turned to left side with angle of 60 or 90 degrees to the left and the patient's back is supported with pillow from the neck until the sacrum, between the legs is again covered with a pillow. After that, the patient's head is elevated with 45-60 degrees. Body temperature is controlled, covered in order to avoid temperature loss and position is completed.

In this unit, after performing the applications related to the method used, the patient's vital signs and SpO2 are checked and recorded every half hour in the postoperative 24 hours, and hourly in the following processes.

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 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • First time experiencing congenital cardiovascular surgery,
  • Having Bilateral pulmonary atelectasis assessment,
  • Not having any secondary congenital anomaly or chronic disease,
  • Not having any neurologic symptoms,
  • Being between 1 month - 1 year old
  • Not having bilateral circulatory disorder and not having any obstacle to the position,
  • Being Intubated
  • Receiving 1 mg/kg dormicum, 0,1 mcg/kg fentaver infusion

排除标准

  • Receiving Extra Corporal Membrane Exygenation support,
  • Admitted to ICU with sternum exposed,
  • Receiving Intraaortic balloon pump support,
  • Being a Pre-op period patient,
  • Having a non-bilateral circulatory disorder,
  • Having unilateral thorax drain,
  • Being extubated or being planned for extubation during the study period,
  • Receiving Rocuranium,
  • Not receiving Dormicum or fentaver

结局指标

主要结局

Change in Oxygen Saturation

时间窗: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

Oxygen Saturation will be monitored.

Change in Blood Pressure

时间窗: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

Blood Pressure will be monitored.

Change in Heart Rate

时间窗: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

Heart rate will be monitored.

Change in Respiratory Rate

时间窗: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

Respiratory rate will be monitored.

Change in Body Temperature

时间窗: Data will be collected immediately before the position is given, at the 1st minute, at the 1st hour and at the 2nd hour after the position is given. The change in these time intervals will be assessed.

This outcome will be considered as one of the vital signs. Body temperature measurement will be evaluated as axillary.

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

Principal Investigator Assist. Prof.

Acibadem University

研究点 (2)

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