NCT05175859

Brief Summary

How timing of tracheostomy in COVID-19 patients changed and its impact on mortality in patients with severe COVID-19 ARDS

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

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

April 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 26, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

1.5 years

First QC Date

December 26, 2021

Last Update Submit

December 28, 2021

Conditions

Tracheostomy

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Deaths in the course of treatment

    During intensive care treatment (Usually within 8 weeks)

Study Arms (2)

Early tracheostomy

Tracheostomy time before day 10 following endotracheal airway management and invasive ventilation.

Late tracheostomy

Tracheostomy time after day 11 following endotracheal airway management and invasive ventilation.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with underlying sheer COVID-19 disease and need for endotracheal airway management. Who required a tracheostomy due to the prolonged ventilation and ventilatory weaning required.

You may qualify if:

  • \- Severe COVID-19 infection requiring endotracheal intubation and prolonged invasive ventilation as part of the treatment of severe to moderate acute respiratory distress syndrome.

You may not qualify if:

  • COVID-19 disease, without the need for endotracheal ventilation.
  • COVID-19 disease with need for endotracheal intubation with anticipated short-term invasive ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt

Niederrad, Hesse, 60590, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2021

First Posted

January 4, 2022

Study Start

April 1, 2020

Primary Completion

October 1, 2021

Study Completion

December 25, 2021

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations

DE(1)