Taste and Smell Impairment in Critically Ill COVID-19 Pat... | NCT04532632

Studies
Taste and Smell Impairment in Critically Ill COVID-19 Patients

NCT04532632

Sponsor

Pinar Ay Sayin

Status

Completed

Last Update Posted

Nov 10, 2020Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Smell Disorder
Taste Disorders
Coronavirus Infection

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Oct 1, 2020Actual

Completion Date

Oct 9, 2020Actual

First Submitted Date

Aug 28, 2020

First Submission Date that Met QC Criteria

Aug 28, 2020

First Posted Date

Aug 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2020

Last Update Posted Date

Nov 10, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pinar Ay Sayin, specialist medical doctor, Sisli Hamidiye Etfal Training and Research HospitalSponsor-Investigator

Lead Sponsor

Pinar Ay SayinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study

Detailed Description

Patients who were treated in the intensive care unit of Şişli Hamidiye Etfal Training and Research Hospital with the diagnosis of Coronavirus disease-19 will be determined by scanning the hospital registry system. It was planned that patients discharged from the intensive care unit would be called by phone and their complaints about smell and taste disorders were evaluated with a questionnaire.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
taste and smell impairment	incidence of taste and smell impairment in critically ill subjects	up to 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults between the ages of 18-80
Agree to participate in the study
Patients treated in the intensive care unit with the diagnosis of Coronavirus disease-19

Exclusion Criteria:

Pre-existing smell and taste impairment
The patients have no enough cooperation to answer the questionnaire
Having additional diseases such as dementia and Alzheimer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients between the ages of 18-80, who were treated in the intensive care unit with the diagnosis of Coronavirus disease-19 and were discharged

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sisli Etfal Research and Training Hospital		Istanbul		34371	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32366299	Background	Hopkins C, Surda P, Whitehead E, Kumar BN. Early recovery following new onset anosmia during the COVID-19 pandemic - an observational cohort study. J Otolaryngol Head Neck Surg. 2020 May 4;49(1):26. doi: 10.1186/s40463-020-00423-8.
32513096	Background	Sayin I, Yasar KK, Yazici ZM. Taste and Smell Impairment in COVID-19: An AAO-HNS Anosmia Reporting Tool-Based Comparative Study. Otolaryngol Head Neck Surg. 2020 Sep;163(3):473-479. doi: 10.1177/0194599820931820. Epub 2020 Jun 9.

ID	Term
D000857	Olfaction Disorders
D013651	Taste Disorders
D018352	Coronavirus Infections
D000086382	COVID-19
D000086582	Anosmia
D004408	Dysgeusia

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms