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临床试验/CTRI/2024/04/065366
CTRI/2024/04/065366尚未招募2/3 期

Effect of completely occlusive nasal pack versus nasal pack with airway on eustachian tube function and arterial blood gas- a randomised controlled trial

Dr Hithyshree N1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年4月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Middle ear aeration and pulmonary ventilation

研究概览

简要总结

Nasal packs are usually used in case of epistaxis and after nasal surgeries to control bleeding and to support and stabilize the bony and cartilaginous structures. Due to packing, patients experience significant discomfort in the post-operative period. Bilateral nasal packing can lead to compromised Eustachian tube function. Eustachian tube patency is very important to maintain middle ear pressure and its dysfunction can lead to Eustachian tube catarrh, secretory otitis media. Nasal obstruction can lead to hypoxia, sleep apnea especially in patients with vulnerable cardiac function or poor lung capacity. Mouth breathing can also lead to imbalance in the acid- base due to disturbance in pulmonary ventilation. Some patients may experience fall in saturation when in deep sleep.

In this study, the pulmonary side effects and alterations in Eustachian tube function associated with the use of nasal packs will be evaluated.

The effect of totally occlusive nasal pack and nasal pack with airways on pulmonary and Eustachian tube function will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients aged between 18- 60 years planned for nasal surgeries and patients with epistaxis requiring bilateral anterior nasal packs.

排除标准

  • Patients with mucociliary disorders
  • Patients requiring posterior nasal pack
  • Patients who have received radiation to nasopharynx or the surrounding areas
  • Very obese patients with history of obstructive sleep apnea
  • Patients with impaired cardiac functions.

结局指标

主要结局

Middle ear aeration and pulmonary ventilation

时间窗: At baseline & Day 1

次要结局

  • Oxygen saturation(Post operative day 1)

研究者

发起方
Dr Hithyshree N
申办方类型
Other [Post graduate resident]
责任方
Principal Investigator
主要研究者

Dr Hithyshree. N

Sri Devaraj urs medical college

研究点 (1)

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