Tracheostomy ComplicationNCT05834972
Ultrasound-guided Versus Landmark-guided Percutaneous Dilational Tracheostomy in Pediatric Patients
An observational study of Tracheostomy Complication and Tracheostomy Hemorrhage, run by Aksaray University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheostomy Complication, Tracheostomy Hemorrhage, Airway Trauma
- What is being tested?
- Ultrasound-guided percutaneous dilatational tracheosyomy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2023to 10 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- healthy pediatric patients
- between 5 and 13 years old
Who cannot join
- neck anomalies
- syndromic patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Ultrasound-guided percutaneous dilatational tracheosyomy
- Keywords
- percutaneous dilatational tracheostomy, ultrasound guided tracheostomy, landmark guided tracheostomy, pediatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided percutaneous dilatational tracheosyomyDevice
Also called Landmark-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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasound-guided percutaneous dilatational tracheosyomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy
Identification of the second and third tracheal ring
Measured: 20 minutes
Secondary outcomes (2)
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
Measured: 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
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start25 Jun 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion10 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengiz Kılıçarslan, Aksaray University
- Investigators
- Cengizhan Kilicaslan, MD, Principal investigator, Pediatrician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834972
- Sponsor's protocol ID
- 34-SBKAEK-2023-05-05
- Status last verified
- Jun 2023
- First submitted
- 18 Apr 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the protocol, measurement tools that we will use, and the statistical analysis plan of the study.
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.
PubMed 29409380
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Versus Landmark-guided Percutaneous Dilational Tracheostomy in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05834972
- Acronym / sponsor ID
- 34-SBKAEK-2023-05-05
- Conditions
- Tracheostomy Complication, Tracheostomy Hemorrhage, Airway Trauma, Percutaneous Tracheostomy
- Keywords
- percutaneous dilatational tracheostomy, ultrasound guided tracheostomy, landmark guided tracheostomy, pediatric patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 25 Jun 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 10 Aug 2023 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: Ultrasound-guided percutaneous dilatational tracheosyomyAll 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. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- healthy pediatric patients
- between 5 and 13 years old
Key exclusion criteria (2 listed)
- neck anomalies
- syndromic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided percutaneous dilatational tracheosyomyAlso: Landmark-guided percutaneous dilatational tracheosyomyAll of the participants will be examined two times. First, the landmark-guided technique will be performed. Then, the ultrasound-guided technique will be performed. | Device | Ultrasound-guided percutaneous dilatational tracheostomy |
Primary outcome
Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy
Time frame: 20 minutes
Identification of the second and third tracheal ring
2 secondary outcomes
Detection of potential complications of the airway entry point determined by the traditional method
Time frame: 20 minutes
The time taken by the landmark-guided and ultrasound-guided techniques
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Background: PubMed 29409380Gobatto 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.
- Individual participant dataSharing planned: Yes. We will share the protocol, measurement tools that we will use, and the statistical analysis plan of the study.
Related trials for Tracheostomy Complication
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
RecruitingObservational study
Increased Body Temperature Post Tracheostomy: a Retrospective Study
Tracheostomy Complication
RecruitingObservational study
Outcomes After Tracheal Cannula Removal
Tracheostomy
RecruitingObservational study
Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
Anesthesia Complication, Tracheostomy Complications
RecruitingObservational study
"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"
Surveillance, Endoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cengizhan Kilicaslan, MD principal investigator
Pediatrician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Complication and Tracheostomy Hemorrhage, run by Aksaray University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cengizhan Kilicaslan, MD (+905052719417, dr_cengizhan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical accuracy of the entry site for percutaneous dilatational tracheostomy (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05834972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.