Percutaneous Tracheostomy With COVID-19 | NCT04447638

Studies
Percutaneous Tracheostomy With COVID-19

NCT04447638

Sponsor

Çanakkale Onsekiz Mart University

Status

Completed

Last Update Posted

Sep 24, 2020Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Tracheostomy

Interventions

Tracheostomy with aerosol box in COVID-19 positive patients

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

Sep 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

Mar 20, 2020Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

Jun 24, 2020

First Submission Date that Met QC Criteria

Jun 24, 2020

First Posted Date

Jun 25, 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

Sep 22, 2020

Last Update Posted Date

Sep 24, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mesut ERBAS, Associate Professor, Çanakkale Onsekiz Mart UniversityPrincipal Investigator

Lead Sponsor

Çanakkale Onsekiz Mart UniversityOTHER

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

Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.

Detailed Description

Different methods are needed for situations in which the potential for producing aerosols is high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients. Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the pandemic intensive care unit were evaluated retrospectively.The study is designed as a clinical trial study. This study was performed in faculty of medicine hospital's intensive care unit which is located in Canakkale province Turkey.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tracheostomy with aerosol box in COVID-19 positive patients	Procedure	Patients who underwent percutaneous tracheostomy with aerosol box in COVID-19 positive patients. The patients age, gender, hospitalization diagnosis, number of intubated days, anesthetic agents used during the procedure, neck ultrasonography data before and during the procedure, and complications were recorded.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box	Complications	During the procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

who underwent percutaneous tracheostomy with COVID-19(+)

Exclusion Criteria:

Patients who do not give informed consent or do not want to participate in the study
Coagulopathy, thrombocytopenia

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Percutaneous tracheostomy performed with aerosol box in COVID-19 patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Canakkale Onsekiz Mart University		Çanakkale		17020	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014139	Tracheostomy

Ancestor Terms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D010030	Ostomy
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided