Clinical trial NCT05845775: Evaluation Of The Effect Of Morphological Structure On Dilatational Tracheostomy Interference Location And Complications
Official title: Evaluation Of The Effect Of Morphological Structure On Dilatational Tracheostomy Interference Location And Complications By Ultrasonography And Fiberoptic Bronchoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheostomy Complication
Keywords: Complications
Intensive care unit
Tracheostomy
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who were decided to open percutaneous dilatational tracheostomy for various reasons will be included in the study.

Brief summary: In recent years, percutaneous dilatational tracheostomy has become a frequently performed procedure in intensive care units. However, tracheostomy procedure has risks of complications of varying severity, such as bleeding, subcutaneous emphysema, posterior tracheal wall damage, tracheal stenosis, infection, and fistula in the early and late periods. It is important to determine the anatomical position for tracheal puncture in reducing the risk of complications. It is not always possible to determine the optimal anatomical position for tracheal puncture in patients in the intensive care unit due to reasons such as obesity patient positioning difficulties and tracheal deviation. In this stuy, we have purpose to evaluate the effect of the morphological structure of patients on the dilatational tracheostomy interference location and complications in the percutaneous dilatational tracheostomy procedure (using anatomical landmarks) performed with the forceps dilatation technique, using fiberoptic bronchoscopy and ultrasonography.

Detailed description: A prospective observational study will be conducted in the Akdeniz University Hospital at the department of Anesthesiology and Intensive Care. Tracheostomy incision site will be determined by using anatomical landmark in all patients. Before the procedure, detailed anatomical measurements showing the morphological structure of the patient (neck thickness, thyromental distance, thyroid cartilage measurement, cricoid cartilage measurement, jugulomental distance, distance between clavicle and cricoid cartilage) will be recorded. In addition, measurements will be made and recorded by ultrasonography. In all patients, the percutaneous dilatational tracheostomy procedure will be performed via fiberoptic bronchoscopy and the tracheal puncture level will be confirmed. Tracheostomy related complications will also be recorded.

Eligibility criteria: Example:

● Patients undergoing percutaneous dilatational tracheotomy

Inclusion Criteria:

● Clinical indication for tracheostomy

Exclusion Criteria:

* Age \<18
* Patients with severe coagulopathy
* Unsuitable anatomy (e.g., previous cervical surgery, cervical trauma, or tumors)

Primary outcomes:
measure: The effect of morphological structure on the percutaneous dilatational tracheostomy
timeFrame: April 30, 2023-October 30, 2023 (6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
Study officials:
affiliation: Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
name: Esin Bulut, MD
role: STUDY_DIRECTOR
References: