跳至主要内容
临床试验/NCT02179554
NCT02179554撤回不适用

Does Cardiopulmonary Bypass Change Olfaction?

Manchester University NHS Foundation Trust1 个研究点 分布在 1 个国家开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
1) Sniffin sticks score out of 16

研究概览

简要总结

The loss of the sense of smell, anosmia, can have profound effects on the lives of those who suffer from it. In our clinical practice, we have encountered several patients complaining of anosmia after recently undergoing surgery requiring cardiopulmonary bypass. We want to investigate this peculiar observation and determine if such a link exists. Thus far, there have been no similar studies published, and as such, no previous evidence on this matter. This study will help formalise and clarify these observations, empowering clinicians to better inform patients in the future; if cardiopulmonary bypass procedures do carry a risk of anosmia. This study may also give rise to further research into the matter.

详细描述

Objectives: To investigate the incidence of anosmia arising in patients after undergoing cardiopulmonary bypass, and compare it to a control group.

Hypothesis: Patients undergoing cardiopulmonary bypass may suffer from anosmia.

Methodology: Potential participants will be identified via scheduled operating lists at Manchester Royal Infirmary. Suitable patients will be informed, including informational leaflets about the study, and permissions sought with an informed consent form. Once recruited, when the patients come for their pre-operative assessment, olfactory assessment will be carried out using the Sniffing Sticks smell kit and a validated questionnaire (Dresden Questionnaire of Olfactory Disorders). The Sniffing Sticks smell kit composes of 12 different pen-like odour dispensers. Each stick is presented to the patient who then chooses from four different answers, the one that best represents the odour. The patient then receives a score of 0 to 12. A reassessment via the same questionnaire and smell kit is repeated after 1 week or just before discharge (whichever is earlier) after the patient's surgery.

Data Management and Statistical Analyses: All participant information will be stored electronically in a password protected trust computer. Participant identifiers will also be kept in a separate password protected folder from the main database of individual participant information. We will use MS Excel for compiling the data.

Study Type: Prospective, single-centre, observational study

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking volunteers above 18 years of age.

排除标准

  • Pre-existing olfaction disorder, nasal polyps.

结局指标

主要结局

1) Sniffin sticks score out of 16

时间窗: 1 day

1) Objective scoring based smell test kit

次要结局

  • 2) Dresden questionnaire of olfactory disorder score(1 day)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Does Cardiopulmonary Bypass Change Olfaction? | 临床试验