NCT02179554

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

June 25, 2014

Last Update Submit

March 16, 2020

Conditions

Anosmia

Outcome Measures

Primary Outcomes (1)

  • 1) Sniffin sticks score out of 16

    1\) Objective scoring based smell test kit

    1 day

Secondary Outcomes (1)

  • 2) Dresden questionnaire of olfactory disorder score

    1 day

Study Arms (1)

cardiopulmonary bypass

Patients undergoing elective surgery requiring cardiopulmonary bypass

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50 patients undergoing elective surgery requiring cardiopulmonary bypass (study group)

You may qualify if:

  • \- English speaking volunteers above 18 years of age.

You may not qualify if:

  • \- Pre-existing olfaction disorder, nasal polyps.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Manchester University Hospitals NHS Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Atef El-Kholy

    Manchester University NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2014

First Posted

July 2, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

GB(1)