Ultrasound-guided Versus Landmark-guided Percutaneous Dilational Tracheostomy in Pediatric Patients

Tracheostomy Complication Clinical Trial

Official title:

Ultrasound-guided Versus Landmark-guided Percutaneous Dilational Tracheostomy in Pediatric Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05834972
• Other study ID #: 34-SBKAEK-2023-05-05
• Status: Not yet recruiting
• Start date: June 25, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: June 2023
• Source: Aksaray University
• Contact: Cengizhan Kilicaslan, MD
• Phone: +905052719417
• Email: dr_cengizhan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 10, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

Inclusion Criteria:

• healthy pediatric patients

• between 5 and 13 years old

Exclusion Criteria:

• neck anomalies

• syndromic patients

Related Conditions & MeSH terms

• Airway Trauma
• Hemorrhage
• Percutaneous Tracheostomy
• Tracheostomy Complication
• Tracheostomy Hemorrhage

Intervention

Device:
• Ultrasound-guided percutaneous dilatational tracheosyomy
All of the participants will be examined two times. First, the landmark-guided technique will be performed. Then, the ultrasound-guided technique will be performed.

Locations

Country	Name	City	State
Turkey	Aksaray University	Aksaray

Sponsors (1)

Lead Sponsor	Collaborator
Aksaray University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy	Identification of the second and third tracheal ring	20 minutes
Secondary	Detection of potential complications of the airway entry point determined by the traditional method	Proximity of the airway entry point determined by the traditional method to vascular and glandular structures	20 minutes
Secondary	The time taken by the landmark-guided and ultrasound-guided techniques	Time taken to determine the airway entry point with landmark-guided and ultrasound-guided techniques	20 minutes