Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy | Identification of the second and third tracheal ring | 20 minutes |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cengizhan Kilicaslan, MD | Contact | +905052719417 | dr_cengizhan@hotmail.com | |
| Ekin Guran, MD | Contact | +905078448449 | drekinguran@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cengizhan Kilicaslan, MD | Pediatrician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aksaray University | Aksaray | 68640 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29409380 | Background | 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. |
Not provided
Not provided
We will share the protocol, measurement tools that we will use, and the statistical analysis plan of the study.
The data will be available after publication.
The data will be uploaded to clinicialtrials.gov
Not provided
Not provided
Not provided
Not provided
Not provided
|
Time taken to determine the airway entry point with landmark-guided and ultrasound-guided techniques |
| 20 minutes |