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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tracheostomy Complication; Percutaneous Tracheostomy; Airway Trauma; Tracheostomy Hemorrhage
• Intervention / Treatment: Device: Ultrasound-guided percutaneous dilatational tracheosyomy

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Cengizhan Kilicaslan, MD; Phone Number: +905052719417; Email: dr_cengizhan@hotmail.com
• Study Contact Backup: Name: Ekin Guran, MD; Phone Number: +905078448449; Email: drekinguran@gmail.com

Study Locations

• Turkey
  • Aksaray, Turkey, 68640
    • Aksaray University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• healthy pediatric patients
• between 5 and 13 years old

Exclusion Criteria:

• neck anomalies
• syndromic patients

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Landmark-guided percutaneous dilatational tracheostomy; All patients will be enrolled two times. First, an experienced anesthesiologist will examine the neck anatomy and mark the second or third tracheal ring using the traditional landmark-guided technique, and the duration will be recorded. Then, the same anesthesiologist will examine the neck anatomy and mark the second or third tracheal ring using the ultrasound (USG)-guided approach, and the duration will be recorded. The distance between these two aforementioned markings will be measured and recorded. The first marking determined by the landmark method will be looked at with USG and where it corresponds anatomically will be recorded. Also, the vascular and glandular structures of the area and potential complications will be noted.
Ultrasound-guided percutaneous dilatational tracheostomy; All patients will be enrolled two times. First, an experienced anesthesiologist will examine the neck anatomy and mark the second or third tracheal ring using the traditional landmark-guided technique, and the duration will be recorded. Then, the same anesthesiologist will examine the neck anatomy and mark the second or third tracheal ring using the ultrasound (USG)-guided approach, and the duration will be recorded. The distance between these two aforementioned markings will be measured and recorded. The first marking determined by the landmark method will be looked at with USG and where it corresponds anatomically will be recorded. Also, the vascular and glandular structures of the area and potential complications will be noted.	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.; Other Names: Landmark-guided percutaneous dilatational tracheosyomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy	Identification of the second and third tracheal ring	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Aksaray University
• Investigators: Principal Investigator: Cengizhan Kilicaslan, MD, Pediatrician

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2023
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 10, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: pediatric patients; ultrasound guided tracheostomy; percutaneous dilatational tracheostomy; landmark guided tracheostomy
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 34-SBKAEK-2023-05-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the protocol, measurement tools that we will use, and the statistical analysis plan of the study.
• IPD Sharing Time Frame: The data will be available after publication.
• IPD Sharing Access Criteria: The data will be uploaded to clinicialtrials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No