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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Body Temperature Post Tracheostomy: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06805214
- Acronym / sponsor ID
- 0021-25-MMC
- Conditions
- Tracheostomy Complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU from 1.2020 to 1.2025 who underwent tracheostomy during ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| post tracheostomy feverincidence of post tracheostomy fever and whether retrospectively the increased temperature indicated development of sepsis or not (no intervention) | Other | – |
Primary outcome
Post tracheostomy fever
Time frame: 24 hours post tracheostomy
Incidence of post tracheostomy fever
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Tracheostomy Complication
RecruitingObservational study
Outcomes After Tracheal Cannula Removal
Tracheostomy
RecruitingObservational study
Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
Anesthesia Complication, Tracheostomy Complications
RecruitingObservational study
"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"
Surveillance, Endoscopy
Enrolling by invitation
Neck Rescue Access Comparison
Tracheostomy Complication, Emergency Front of Neck Airway in Children
Recruiting
PUSH-IT Continuing Enteral Feeds for Tracheostomy
Tracheostomy Complication, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Complication, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post tracheostomy fever (time frame: 24 hours post tracheostomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.