Clinical trial NCT05834972: Ultrasound-guided Versus Landmark-guided Percutaneous Dilational Tracheostomy in Pediatric Patients
Official title: Ultrasound-guided Versus Landmark-guided Percutaneous Dilational Tracheostomy in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tracheostomy Complication
Tracheostomy Hemorrhage
Airway Trauma
Percutaneous Tracheostomy
Keywords: percutaneous dilatational tracheostomy
ultrasound guided tracheostomy
landmark guided tracheostomy
pediatric patients
Lead sponsor: Aksaray University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pediatric patients between 5 and 13 years old and admitted to the operating theatre and sedated will be included after the consent of their parents or legal guardians.

Brief summary: Percutaneous dilatational tracheostomy is one of the most common procedures performed in pediatric intensive care units. The investigators aimed to compare traditional landmark-guided percutaneous dilatational tracheostomy (PDT) and ultrasound-guided percutaneous dilatational tracheostomy in pediatric patients in terms of location, duration, and potential complications related to the procedure.

Detailed description: Tracheostomy, one of the most common procedures performed in intensive care units (ICU), refers to creating a stoma in the anterior wall of the trachea to maintain airway security. Tracheostomy can be formed via a surgical or percutaneous dilatational technique (1). The surgical technique requires the transportation of the patient to the operating theatre, while the percutaneous dilatational technique can be performed in the ICU. Thus, ICU practitioners commonly prefer the percutaneous dilatational technique.

Percutaneous dilatational tracheostomy can be performed via three approaches: landmark, ultrasound (USG), or bronchoscopy guided. Although landmark-guided PTD is a practical approach, there are growing concerns regarding the location of the second and third tracheal rings and injuries to vascular structures and the thyroid gland. USG may be helpful to establish the anatomy of the airway and the vascular and glandular structure of the area.

The investigators aimed to compare traditional landmark-guided percutaneous dilatational tracheostomy and USG-guided percutaneous dilatational tracheostomy in pediatric patients in terms of location, duration, and potential complications related to the procedure.

Eligibility criteria: Inclusion Criteria:

* healthy pediatric patients
* between 5 and 13 years old

Exclusion Criteria:

* neck anomalies
* syndromic patients

Primary outcomes:
measure: Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy
timeFrame: 20 minutes
Secondary outcomes:
measure: Detection of potential complications of the airway entry point determined by the traditional method
timeFrame: 20 minutes
measure: The time taken by the landmark-guided and ultrasound-guided techniques
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University
Study officials:
affiliation: Pediatrician
name: Cengizhan Kilicaslan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gobatto ALN, Besen BAMP, Cestari M, Pelosi P, Malbouisson LMS. Ultrasound-Guided Percutaneous Dilational Tracheostomy: A Systematic Review of Randomized Controlled Trials and Meta-Analysis. J Intensive Care Med. 2020 May;35(5):445-452. doi: 10.1177/0885066618755334. Epub 2018 Feb 7.