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

NCT ID: NCT05834972

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-25
• Study Completion Date: 2023-08-10

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.

Conditions

Tracheostomy Complication; Tracheostomy Hemorrhage; Airway Trauma; Percutaneous Tracheostomy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

Ultrasound-guided percutaneous dilatational tracheosyomy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Landmark-guided percutaneous dilatational tracheosyomy

Eligibility Criteria

Inclusion Criteria

• healthy pediatric patients
• between 5 and 13 years old

Exclusion Criteria

• neck anomalies
• syndromic patients

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aksaray University

OTHER

Sponsor Role: lead

Responsible Party

Cengiz Kılıçarslan

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cengizhan Kilicaslan, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatrician

Locations

Aksaray University

Aksaray, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Cengizhan Kilicaslan, MD

Role: CONTACT

dr_cengizhan@hotmail.com

+905052719417

Ekin Guran, MD

Role: CONTACT

drekinguran@gmail.com

+905078448449

References

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.

Reference Type: BACKGROUND

PMID: 29409380 (View on PubMed)

Other Identifiers

34-SBKAEK-2023-05-05

Identifier Type: -

Identifier Source: org_study_id