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

Sponsor
Aksaray University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05834972
Collaborator
(none)
100
1
2.2
45.4

Study Details

Study Description

Brief Summary

Percutaneous dilatational tracheostomy is one of the most common procedures performed in pediatric intensive care units. We 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.

Condition or Disease Intervention/Treatment Phase
  • 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.

We 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Ultrasound-guided Versus Landmark-guided Percutaneous Dilational Tracheostomy in Pediatric Patients
Anticipated Study Start Date :
Apr 25, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy [20 minutes]

      Identification of the second and third tracheal ring

    Secondary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 13 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • healthy pediatric patients

    • between 5 and 13 years old

    Exclusion Criteria:
    • neck anomalies

    • syndromic patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aksaray University Aksaray Turkey 68640

    Sponsors and Collaborators

    • Aksaray University

    Investigators

    • Principal Investigator: Cengizhan Kilicaslan, MD, Pediatrician

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cengiz Kılıçarslan, Medical Doctor, Aksaray University
    ClinicalTrials.gov Identifier:
    NCT05834972
    Other Study ID Numbers:
    • 34-SBKAEK-2023-05-05
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cengiz Kılıçarslan, Medical Doctor, Aksaray University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 28, 2023