NCT06805214

Brief Summary

Tracheostomy is one of the most common procedures in intensive care units. Post-tracheostomy increased body temperature within 24 hours is common. However, frequently sepsis workup is performed along with initiation of broad spectrum antibiotic therapy. We will investigate the incidence of post tracheostomy fever and whether retrospectively the increased temperature indicated development of sepsis or not. The study is retrospective and will be based on data collection.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress36%
May 2025Mar 2028

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

January 28, 2025

Last Update Submit

May 7, 2025

Conditions

Tracheostomy Complication

Outcome Measures

Primary Outcomes (1)

  • Post tracheostomy fever

    Incidence of post tracheostomy fever

    24 hours post tracheostomy

Interventions

post tracheostomy feverOTHER

incidence of post tracheostomy fever and whether retrospectively the increased temperature indicated development of sepsis or not (no intervention)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the ICU from 1.2020 to 1.2025 who underwent tracheostomy during ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Study Design

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

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)