Airway UltrasoundNCT06664294
The USE of ULTRASONOGRAPHY in CONFIRMING SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT in PEDIATRIC PATIENTS
An observational study of Airway Ultrasound, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
In this study,the investigators evaluated the placement of the supraglottic airway device with ultrasonographic imaging. Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Ultrasound
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2024to 29 Apr 2025
- How long will I take part?
- 1 Day
- 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 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients aged 3-15 years with an operation time of less than 2 hours
Who may be able to join
- Patients with informed consent from their parents
- Patients with ASA I-II physical status
- Patients with appropriate fasting time
- Those with an operation time of less than 2 hours
Who cannot join
- ASA III-IV physical status patients
- Patients with respiratory tract infections
- Patients undergoing head and neck surgery
- Patients with oropharyngeal pathology
- Patients with gastrointestinal obstruction
- Patients with tracheomalacia
- Patients who need to be intubated for anesthesia applications
Trial locations and contacts
1 site in 1 country.
About this study
In this study,the investigators evaluated the placement of the supraglottic airway device with ultrasonographic imaging.
Read the detailed description
After informing the patients about the study and possible risks, written consent was obtained from all patients. After routine anesthesia technique was applied to the patients, supraglottic airway device was inserted. The placement of the airway device was evaluated with ultrasonography. Airway pressures reflected on the anesthesia device were recorded. The correlation between airway pressures and ultrasonographic images was evaluated.
- Conditions
- Airway Ultrasound
- Keywords
- supraglottic airway pediatric airway,airway ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between ultrasonography and clinical tests
Our primary aim was investigation of correlation between ultrasonography and clinical tests for placement of supraglottic airway device in pediatric patients.
Measured: 24 hours
Secondary outcomes (1)
mesuring airway pressures
Our secondary aim was measuring airway pressures, measuring the difference between the tidal volume delivered from the anesthesia device and the volume withdrawn from the patient, and its correlation with correct placement
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start29 Jul 2024
- Primary completion29 Jan 2025 (estimated)
- Study completion29 Apr 2025 (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 Airway UltrasoundStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Yaka, Kocaeli University
- Investigators
- can aksu, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664294
- Sponsor's protocol ID
- KAEK2024/171
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Çalışmanın kopyalanmasının önüne geçmek için
Publications
Kim J, Kim JY, Kim WO, Kil HK. An ultrasound evaluation of laryngeal mask airway position in pediatric patients: an observational study. Anesth Analg. 2015 Feb;120(2):427-32. doi: 10.1213/ANE.0000000000000551.
PubMed 25545750
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The USE of ULTRASONOGRAPHY in CONFIRMING SUPRAGLOTTIC AIRWAY DEVICE PLACEMENT in PEDIATRIC PATIENTS
- ClinicalTrials.gov ID
- NCT06664294
- Acronym / sponsor ID
- KAEK2024/171
- Conditions
- Airway Ultrasound
- Keywords
- supraglottic airway pediatric airway,airway ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 29 Jan 2025 (estimated)
- Study completion
- 29 Apr 2025 (estimated)
- First posted
- 29 Oct 2024 (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.
In this study,the investigators evaluated the placement of the supraglottic airway device with ultrasonographic imaging.
Detailed description
After informing the patients about the study and possible risks, written consent was obtained from all patients. After routine anesthesia technique was applied to the patients, supraglottic airway device was inserted. The placement of the airway device was evaluated with ultrasonography. Airway pressures reflected on the anesthesia device were recorded. The correlation between airway pressures and ultrasonographic images was evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 3-15 years with an operation time of less than 2 hours
Key inclusion criteria (4 listed)
- Patients with informed consent from their parents
- Patients with ASA I-II physical status
- Patients with appropriate fasting time
- Those with an operation time of less than 2 hours
Key exclusion criteria (7 listed)
- ASA III-IV physical status patients
- Patients with respiratory tract infections
- Patients undergoing head and neck surgery
- Patients with oropharyngeal pathology
- Patients with gastrointestinal obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between ultrasonography and clinical tests
Time frame: 24 hours
Our primary aim was investigation of correlation between ultrasonography and clinical tests for placement of supraglottic airway device in pediatric patients.
1 secondary outcome
mesuring airway pressures
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 25545750Kim J, Kim JY, Kim WO, Kil HK. An ultrasound evaluation of laryngeal mask airway position in pediatric patients: an observational study. Anesth Analg. 2015 Feb;120(2):427-32. doi: 10.1213/ANE.0000000000000551.
- Individual participant dataSharing planned: No. Çalışmanın kopyalanmasının önüne geçmek için
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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.
can aksu study director
Kocaeli University
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 Airway Ultrasound, run by Kocaeli 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 4 inclusion and 7 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 29 Oct 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between ultrasonography and clinical tests (time frame: 24 hours). 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 NCT06664294, 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 29 Oct 2024.