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

NCT05834972 | Unknown

• 1 other identifier: 34-SBKAEK-2023-05-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy Complication; Tracheostomy Hemorrhage; Airway Trauma; Percutaneous Tracheostomy

Keywords

percutaneous dilatational tracheostomy; ultrasound guided tracheostomy; landmark guided tracheostomy; pediatric patients

Outcome Measures

Primary Outcomes (1)

• Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy

  Identification of the second and third tracheal ring

  20 minutes

Secondary Outcomes (2)

• Detection of potential complications of the airway entry point determined by the traditional method

  20 minutes

• The time taken by the landmark-guided and ultrasound-guided techniques

  20 minutes

Study Arms (2)

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

Interventions

Ultrasound-guided percutaneous dilatational tracheosyomy DEVICE

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.

Also known as: Landmark-guided percutaneous dilatational tracheosyomy

Ultrasound-guided percutaneous dilatational tracheostomy

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• healthy pediatric patients
• between 5 and 13 years old

You may not qualify if:

• neck anomalies
• syndromic patients

Sponsors & Collaborators

• Aksaray University: lead

Study Sites (1)

Aksaray University

Aksaray, 68640, Turkey (Türkiye)

Location

Related 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.

  PMID: 29409380 BACKGROUND

Study Officials

• Cengizhan Kilicaslan, MD

  Pediatrician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cengizhan Kilicaslan, MD

CONTACT

+905052719417; dr_cengizhan@hotmail.com

Ekin Guran, MD

CONTACT

+905078448449; drekinguran@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: June 25, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 10, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after publication.
• Access Criteria: The data will be uploaded to clinicialtrials.gov

Locations

TU (1)