Difficult AirwayNCT05336474
Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatrics
An observational study of Difficult Airway, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to assess the accuracy of ultrasonographic parameters in combination to clinical parameters in the prediction of difficult airway in pediatric population. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway
- What is being tested?
- Ultrasonographic upper airway measurements
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Sep 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 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The patients, aged between 1-12 years, who required endotracheal intubation under general anesthesia for elective procedures were included in the study.
Who may be able to join
- Children, aged between 1-12 years
- Children who required endotracheal intubation under general anesthesia for elective procedures
- written informed parental consent
Who cannot join
- children over the age of 12
- restrictive neck movement
- tracheostomized patient
- previous laryngeal surgery leading deformation of the laryngeal anatomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University, Istanbul Faculty of Medicine
Istanbul
Demet Altun, 00905326811767, drdemetaltun@hotmail.com
About this study
Official title: Evaluation of Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatric Patients
This study was designed to assess the accuracy of ultrasonographic parameters in combination to clinical parameters in the prediction of difficult airway in pediatric population.
All patients underwent a standard airway examination and sonographic airway assessment preoperatively and the predictive values for difficult airway of these methods were recorded.
Read the detailed description
Difficult airway in a pediatric patient is associated with more stresful situation than adults. Therefore, various clinical airways parameters have been investigated in the prediction of difficult airway. Sonographic evaluation to predict difficult airway is still primitive especially in pediatrics.
Ultrasonography and clinical parameters have been shown to be used in predicting difficult airway, but there is no study showing which is a better predictor.
- Conditions
- Difficult Airway
- Being tested
- Ultrasonographic upper airway measurements
- Keywords
- difficult airway, pediatric anesthesia, laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic upper airway measurementsDiagnostic test
Ultrasonographic upper airway measurements: Epiglottis-skin distance, Hyoid bone-skin distance, Anterior commissure-skin distance and Thickness of tounge
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack-Lehane Classification
he anesthesiologist, who is blind to the patient's preoperative airway evaluation and ultrasonographic airway measurements, performs intubation and evaluates the laryngeal view.
Measured: Three minutes after induction of anesthesia.
Epiglottis skin distance in centimeters.
The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures hyoid bone to skin distance.
Measured: Five minutes before induction of anesthesia.
Hyoid bone-skin distance in centimeters.
The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures hyoid bone to skin distance.
Measured: Five minutes before induction of anesthesia.
Anterior commissure-skin distance in centimeters.
The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures anterior commissure to skin distance.
Measured: Five minutes before induction of anesthesia
Thickness of tongue root in centimeters
The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures thickness of tongue root.
Measured: Five minutes before induction of anesthesia
Secondary outcomes (7)
intubation difficulty score (IDS )(between 0 to 7)
The anesthesiologist, who performed the intubation, evaluated the intubation difficulty.
Measured: During the intubation period
Mallampati classification
Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
Neck circumference in centimeters.
Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
Sternomental distance in centimeters.
The distance between sternal notch and mentum. Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
Thyromental distance in centimeters
The distance between thyroid notch and mentum. Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.Evaluated by the anesthesiologist who performs intubation.
Measured: The day before surgery
intubation techniques
techniques consisting of classic laryngoscope, videolaryngoscope, stylet, and supraglottic airway device used in intubation
Measured: During the intubation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Apr 2022
- Primary completion10 Sep 2023 (estimated)
- Study completion30 Sep 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 Difficult AirwayStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Altun, Istanbul University
- Investigators
- Demet Altun, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336474
- Sponsor's protocol ID
- 2020/132
- Status last verified
- May 2023
- First submitted
- 11 Apr 2022
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Inal MT, Memis D, Sahin SH, Gunday I. [Comparison of different tests to determine difficult intubation in pediatric patients]. Rev Bras Anestesiol. 2014 Nov-Dec;64(6):391-4. doi: 10.1016/j.bjan.2014.02.001. Epub 2014 Aug 28. Portuguese.
PubMed 25437694
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anatomical and Ultrasonographic Parameters to Predict Difficult Airway in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05336474
- Acronym / sponsor ID
- 2020/132
- Conditions
- Difficult Airway
- Keywords
- difficult airway, pediatric anesthesia, laryngoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 10 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 20 Apr 2022 (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.
This study was designed to assess the accuracy of ultrasonographic parameters in combination to clinical parameters in the prediction of difficult airway in pediatric population.
All patients underwent a standard airway examination and sonographic airway assessment preoperatively and the predictive values for difficult airway of these methods were recorded.
Detailed description
Difficult airway in a pediatric patient is associated with more stresful situation than adults. Therefore, various clinical airways parameters have been investigated in the prediction of difficult airway. Sonographic evaluation to predict difficult airway is still primitive especially in pediatrics.
Ultrasonography and clinical parameters have been shown to be used in predicting difficult airway, but there is no study showing which is a better predictor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The patients, aged between 1-12 years, who required endotracheal intubation under general anesthesia for elective procedures were included in the study.
Key inclusion criteria (3 listed)
- Children, aged between 1-12 years
- Children who required endotracheal intubation under general anesthesia for elective procedures
- written informed parental consent
Key exclusion criteria (4 listed)
- children over the age of 12
- restrictive neck movement
- tracheostomized patient
- previous laryngeal surgery leading deformation of the laryngeal anatomy
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 |
|---|---|---|
| Ultrasonographic upper airway measurementsUltrasonographic upper airway measurements: Epiglottis-skin distance, Hyoid bone-skin distance, Anterior commissure-skin distance and Thickness of tounge | Diagnostic test | – |
Primary outcome
Cormack-Lehane Classification
Time frame: Three minutes after induction of anesthesia.
he anesthesiologist, who is blind to the patient's preoperative airway evaluation and ultrasonographic airway measurements, performs intubation and evaluates the laryngeal view.
Epiglottis skin distance in centimeters.
Time frame: Five minutes before induction of anesthesia.
The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures hyoid bone to skin distance.
Hyoid bone-skin distance in centimeters.
Time frame: Five minutes before induction of anesthesia.
The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures hyoid bone to skin distance.
Anterior commissure-skin distance in centimeters.
Time frame: Five minutes before induction of anesthesia
The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures anterior commissure to skin distance.
Thickness of tongue root in centimeters
Time frame: Five minutes before induction of anesthesia
The anesthesiologist, who is blind to the patient's preoperative airway evaluation and is experienced user of ultrasonography, measures thickness of tongue root.
7 secondary outcomes
intubation difficulty score (IDS )(between 0 to 7)
Time frame: During the intubation period
Mallampati classification
Time frame: The day before surgery
Neck circumference in centimeters.
Time frame: The day before surgery
Sternomental distance in centimeters.
Time frame: The day before surgery
Thyromental distance in centimeters
Time frame: The day before surgery
Body mass index (BMI)
Time frame: The day before surgery
intubation techniques
Time frame: During the intubation period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 25437694Inal MT, Memis D, Sahin SH, Gunday I. [Comparison of different tests to determine difficult intubation in pediatric patients]. Rev Bras Anestesiol. 2014 Nov-Dec;64(6):391-4. doi: 10.1016/j.bjan.2014.02.001. Epub 2014 Aug 28. Portuguese.
- Individual participant dataSharing planned: Undecided
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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.
Demet Altun principal investigator
Istanbul 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 Difficult Airway, run by Istanbul 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 3 inclusion and 4 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 9 May 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 Demet Altun (00905326811767, drdemetaltun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cormack-Lehane Classification (time frame: Three minutes after induction of anesthesia.). The study lists 5 primary outcomes in all. 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 NCT05336474, 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 9 May 2023.