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

Not yet recruiting

• Conditions: Tracheostomy Complication; Airway Trauma; Tracheostomy Hemorrhage; Percutaneous Tracheostomy

• Registration Number: NCT05834972
• Lead Sponsor: Aksaray University

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.

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07
• Study Start: 2023-06-25
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• healthy pediatric patients
• between 5 and 13 years old

Exclusion Criteria

• neck anomalies
• syndromic patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy	20 minutes	Identification of the second and third tracheal ring

Secondary Outcome Measures

Name	Time	Method
The time taken by the landmark-guided and ultrasound-guided techniques	20 minutes	Time taken to determine the airway entry point with landmark-guided and ultrasound-guided techniques
Detection of potential complications of the airway entry point determined by the traditional method	20 minutes	Proximity of the airway entry point determined by the traditional method to vascular and glandular structures

Trial Locations

Locations (1)

Aksaray University; 🇹🇷 Aksaray, Turkey