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ICU study: does incision direction matter for tracheostomy safety?

NCT ID NCT07663461

Knowledge-focused Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 74 ICU patients who needed a tracheostomy (a breathing tube through the neck). Doctors made either a vertical or horizontal cut in the skin to see which caused fewer early problems like bleeding or difficulty placing the tube. The goal was to find out if one incision type is safer and easier within the first 24 hours after the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

74 people

The number who actually took part.

Started

Sep 2023

Finished

Sep 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients aged 18 and over who are intubated in the Intensive Care Unit for various reasons and for whom tracheostomy is planned:

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients admitted to the Intensive Care Unit who are intubated for various reasons and for whom tracheostomy is planned. * Patients aged 18 and over. Exclusion Criteria: * Patients for whom they or their first-degree relatives did not give consent. * Coagulation disorder (aPTT ≥35.5 sec, INR ≥1.5 or platelet count ≤50,000/mm3) ≤50,000/mm3) * Difficulty in neck lengthening * Spinal cord injury * Neck deformity (hematoma, tumor, thyroid enlargement) * Neck soft tissue infection * Local malignancy * Obesity * Short neck * History of previous tracheostomy * History of radiotherapy to the neck region had difficulty with neck extension had spinal cord injury had neck distortion (hematoma, tumor, thyromegaly) had neck soft tissue infection had local malignancy were obese or had a short neck had a previous tracheostomy had a history of radiotherapy to the neck

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Percutaneous dilatational tracheostomy early complications

Contacts and locations

Locations

  • Bursa yüksek ihtisas educate ve resourches hospital BURSA, Bursa, Türkiye

    Bursa, Bursa, 16165, Turkey (Türkiye)