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临床试验/NCT01562691
NCT01562691已完成4 期

Comparison of Nasal Packing Methods:Nasal Packing Was Done With Nasopore@, Airway-integrated Nasopore@ and Airway-integrated Vaseline Gauze

Chi Mei Medical Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
oxyhemoglobin saturation by pulse oximetry, SpO2

研究概览

简要总结

The purpose of this study is to determine the effect of integrated airway in nasal packing material foe patients receiving nasal septoplasty surgery.

详细描述

Nasal packing with integrated airway had been claimed to improve body oxygenation following septal surgery. This randomized control study examined the effect of airway integrated with nasal packing, in terms of its improvement on oxygen saturation. Sixty patients with septal deviation and hypertrophic turbinate were randomized into three groups. Group 1 patients were packed with only nasopore@ after surgery. Nasopore@ with integrated airway was used for group 2 patients; and Vaseline gauze integrated with airway for group 3 patients. Hemodynamic parameters were sequentially checked. Nasal pain sensation was recorded using visual analog scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients who underwent septoplasty for septal deviation and chronic hypertrophic rhinitis

排除标准

  • patients with comorbidities of coronary heart disease, arrhythmia, chronic obstructive lung diseases, and with past history of any nasal surgery were excluded.

结局指标

主要结局

oxyhemoglobin saturation by pulse oximetry, SpO2

时间窗: SpO2 was measured 30 minutes before operation,

SpO2 was measured 30 minutes before operation using O2 saturation monitor.

change of SpO2 from baseline to 4 hours post-operation

时间窗: records of the SpO2 at 4 hours post-operation

records of the SpO2 at 4 hours post-operation

change of the SpO2 from baseline to 6 hours post-operation

时间窗: records of the SpO2 at 6 hours post-operation

records of the SpO2 at 6 hours post-operation

change of the SpO2 from baseline to 12 hours post-operation

时间窗: records of the SpO2 at 12 hours post-operation

records of the SpO2 at 12 hours post-operation

change of the SpO2 from baseline to 18 hours post-operation

时间窗: records of the SpO2 at 18 hours post-operation

records of the SpO2 at 18 hours post-operation

change of the SpO2 from baseline to 48 hours post-operation

时间窗: records of the SpO2 at 48 hours post-operation

records of the SpO2 at 48 hours post-operation

次要结局

  • postoperation pain(record of postoperation pain scale at 2 hous post operation)
  • change of postoperation pain scale from baseline to 4 hours post-operation(record of postoperation pain scale at 4 hours post-operation)
  • change of postoperation pain scale from baseline to 6 hours post-operation(Record of postoperation pain scale at 6 hours post-operation)

研究者

发起方
Chi Mei Medical Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yung-Song Lin

Chairman of department of Otolaryngology

Chi Mei Medical Hospital

研究点 (2)

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