NCT04447638

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

June 24, 2020

Last Update Submit

September 22, 2020

Conditions

Tracheostomy

Keywords

Reanimation

Outcome Measures

Primary Outcomes (1)

  • Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box

    Complications

    During the procedure

Interventions

Tracheostomy with aerosol box in COVID-19 positive patientsPROCEDURE

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Percutaneous tracheostomy performed with aerosol box in COVID-19 patients

You may qualify if:

  • who underwent percutaneous tracheostomy with COVID-19(+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, 17020, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tracheostomy

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsOstomySurgical Procedures, OperativeOtorhinolaryngologic Surgical ProceduresThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 25, 2020

Study Start

March 20, 2020

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 24, 2020

Record last verified: 2020-09

Locations

TU(1)