Tracheostomy ComplicationNCT06805214
Increased Body Temperature Post Tracheostomy: a Retrospective Study
An observational study of Tracheostomy Complication, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tracheostomy Complication
- What is being tested?
- post tracheostomy fever
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2025to 1 Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU from 1.2020 to 1.2025 who underwent tracheostomy during ICU admission
Inclusion Criteria: Patients admitted to the ICU from 1.2020 to 1.2025 who underwent tracheostomy during ICU admission -
Exclusion Criteria: Patients who did not fullfil the above criteria
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Sara Dichtwald, Dr., 972-9-7472133 ext. 1, sara.dichtwald@clalit.org.il
About this study
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.
- Conditions
- Tracheostomy Complication
- Being tested
- post tracheostomy fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post tracheostomy feverOther
incidence of post tracheostomy fever and whether retrospectively the increased temperature indicated development of sepsis or not (no intervention)
What is being measured
The primary outcome is the main question the study is designed to answer.
Post tracheostomy fever
Incidence of post tracheostomy fever
Measured: 24 hours post tracheostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 May 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805214
- Sponsor's protocol ID
- 0021-25-MMC
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No