Intubation; Difficult or FailedNCT05833347
Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients
An observational study of Intubation; Difficult or Failed and Difficult Laryngoscopy, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Pediatric patients pose challenges in airway management due to anatomical and physiological changes. Using recommended predictive tests for predicting difficult airway can be improved by combining them with ultrasound measurement of the anterior soft tissues of the neck. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Difficult Laryngoscopy
- What is being tested?
- Distance between Skin-Hyoid Bone(DSHB), Distance between Skin-Vocal Cord Anterior Commissura(DSAC) and Distance between Skin-Epiglottic(DSE)
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2023to 4 Jan 2024
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A hundred twenty patients, aged 2-8 years-old, with an American Anesthesiology Association physical classification (ASA) I-III planned to undergo general anesthesia for elective surgery, will be included in the study.
Who may be able to join
- Patients planned to undergo general anesthesia for elective surgery
- American Anesthesiology Association physical classification (ASA) status I-III
- Body mass index (BMI) above 30
Who cannot join
- Patients with a history of difficult airway or with conditions that are known to be associated with a difficult airway, such as syndromic or metabolic diseases.
- Patients with congenital maxillofacial defects.
- Patients with tracheal or laryngeal pathology.
- Patients with pulmonary diseases such as bronchial asthma or airway hyperreactivity.
- Patients with allergies to ultrasound gel.
- Patients with weight percentile outside the range of 10-90 percentiles.
- Patients undergoing emergency surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, Eskişehir, 26040
About this study
Pediatric patients pose challenges in airway management due to anatomical and physiological changes. Using recommended predictive tests for predicting difficult airway can be improved by combining them with ultrasound measurement of the anterior soft tissues of the neck. In this study, the investigators aim to evaluate the ultrasound measurement of anterior neck soft tissues in paediatric patients before anesthesia induction, to anticipate difficult laryngoscopy.
Read the detailed description
Eligible participants for this study will be patients aged 2-8 years scheduled for elective surgery under general anesthesia who have provided informed consent. During the preoperative evaluation, demographic data and airway physical examination results (Mallampati score) of the patients will be recorded. Patients who have received preoperative sedation will be positioned supine on the operating table, and ultrasound-guided measurements of soft tissue distances will be taken using a linear probe with a frequency range of 6-13 Hz. The distance between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure and skin (DSAC), and distance between the epiglottis and skin (DSE) will be measured. The A/E (Anterior Commissura/Epiglottis) ratio will be calculated after measurements.
After standard monitoring and anesthesia induction, difficult laryngoscopy will be evaluated using the Modified Cormack Lehane Score, which grades the visibility of vocal cords and glottic structures. A grade of 3 or 4 on this scale will be considered as difficult laryngoscopy and recorded as such. Tracheal intubation will be performed by an anesthesiologist with at least two years of experience who is unaware of the ultrasound measurements.
- Being tested
- Distance between Skin-Hyoid Bone(DSHB), Distance between Skin-Vocal Cord Anterior Commissura(DSAC), Distance between Skin-Epiglottic(DSE)
- Keywords
- Difficult laryngoscopy, Ultrasonography, Pediatric Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance between Skin-Hyoid Bone(DSHB)Diagnostic test
Hyoid bone-skin distance Other Name: DSHB
Distance between Skin-Vocal Cord Anterior Commissura(DSAC)Diagnostic test
Vocal cord anterior commissura-skin distance Other Name: DSAC
Distance between Skin-Epiglottic(DSE)Diagnostic test
Skin-epiglottic distance Other Name: DSE
| Study group | Role | What they receive |
|---|---|---|
| 2-8 Years Paediatric Patients | During the preoperative evaluation, demographic data and airway physical examination results (Mallampati score) of the patients will be recorded. Patients who have received preoperative sedation will be positioned supine on the operating table, and ultrasound-guided measurements of soft tissue distances will be taken using a linear probe with a frequency range of 6-13 Hz. The distance between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure and skin (DSAC), and distance between the epiglottis and skin (DSE) will be measured. The A/E (Anterior Commissura/Epiglottis) ratio will be calculated after measurements.
After standard monitoring and anesthesia induction, difficult laryngoscopy will be evaluated using the Modified Cormack Lehane Score, which grades the visibility of vocal cords and glottic structures. A grade of 3 or 4 on this scale will be considered as difficult laryngoscopy and recorded as such. Receives: Diagnostic Test: Distance between Skin-Hyoid Bone(DSHB); Diagnostic Test: Distance between Skin-Vocal Cord Anterior Commissura(DSAC); Diagnostic Test: Distance between Skin-Epiglottic(DSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult laryngoscopy
As the primary outcome, correlation of distance between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure and skin (DSAC), and distance between the epiglottis and skin (DSE) and A/E (Anterior Commissura/Epiglottis) ratio with the Cormack Lehane score will be evaluated.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start10 May 2023
- Primary completion15 Dec 2023
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Kaya, Eskisehir Osmangazi University
- Investigators
- Osman Kaya, Res Assist., Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833347
- Sponsor's protocol ID
- ESOGU-OKAYA-001
- Status last verified
- Nov 2023
- First submitted
- 17 Apr 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
PubMed 25403231Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
PubMed 31742568Altun D, Kara H, Bozbora E, Ali A, Dinc T, Sonmez S, Buget M, Aydemir L, Basaran B, Tugrul M, Camci E. The Role of Indirect Laryngoscopy, Clinical and Ultrasonographic Assessment in Prediction of Difficult Airway. Laryngoscope. 2021 Feb;131(2):E555-E560. doi: 10.1002/lary.28849. Epub 2020 Jul 30.
PubMed 32730647
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05833347
- Acronym / sponsor ID
- ESOGU-OKAYA-001
- Keywords
- Difficult laryngoscopy, Ultrasonography, Pediatric Airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 27 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.
Pediatric patients pose challenges in airway management due to anatomical and physiological changes. Using recommended predictive tests for predicting difficult airway can be improved by combining them with ultrasound measurement of the anterior soft tissues of the neck. In this study, the investigators aim to evaluate the ultrasound measurement of anterior neck soft tissues in paediatric patients before anesthesia induction, to anticipate difficult laryngoscopy.
Detailed description
Eligible participants for this study will be patients aged 2-8 years scheduled for elective surgery under general anesthesia who have provided informed consent. During the preoperative evaluation, demographic data and airway physical examination results (Mallampati score) of the patients will be recorded. Patients who have received preoperative sedation will be positioned supine on the operating table, and ultrasound-guided measurements of soft tissue distances will be taken using a linear probe with a frequency range of 6-13 Hz. The distance between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure and skin (DSAC), and distance between the epiglottis and skin (DSE) will be measured. The A/E (Anterior Commissura/Epiglottis) ratio will be calculated after measurements.
After standard monitoring and anesthesia induction, difficult laryngoscopy will be evaluated using the Modified Cormack Lehane Score, which grades the visibility of vocal cords and glottic structures. A grade of 3 or 4 on this scale will be considered as difficult laryngoscopy and recorded as such. Tracheal intubation will be performed by an anesthesiologist with at least two years of experience who is unaware of the ultrasound measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2-8 Years Paediatric Patients | – | Diagnostic Test: Distance between Skin-Hyoid Bone(DSHB), Diagnostic Test: Distance between Skin-Vocal Cord Anterior Commissura(DSAC), Diagnostic Test: Distance between Skin-Epiglottic(DSE)During the preoperative evaluation, demographic data and airway physical examination results (Mallampati score) of the patients will be recorded. Patients who have received preoperative sedation will be positioned supine on the operating table, and ultrasound-guided measurements of soft tissue distances will be taken using a linear probe with a frequency range of 6-13 Hz. The distance between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure and skin (DSAC), and distance between the epiglottis and skin (DSE) will be measured. The A/E (Anterior Commissura/Epiglottis) ratio will be calculated after measurements. After standard monitoring and anesthesia induction, difficult laryngoscopy will be evaluated using the Modified Cormack Lehane Score, which grades the visibility of vocal cords and glottic structures. A grade of 3 or 4 on this scale will be considered as difficult laryngoscopy and recorded as such. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A hundred twenty patients, aged 2-8 years-old, with an American Anesthesiology Association physical classification (ASA) I-III planned to undergo general anesthesia for elective surgery, will be included in the study.
Key inclusion criteria (3 listed)
- Patients planned to undergo general anesthesia for elective surgery
- American Anesthesiology Association physical classification (ASA) status I-III
- Body mass index (BMI) above 30
Key exclusion criteria (7 listed)
- Patients with a history of difficult airway or with conditions that are known to be associated with a difficult airway, such as syndromic or metabolic diseases.
- Patients with congenital maxillofacial defects.
- Patients with tracheal or laryngeal pathology.
- Patients with pulmonary diseases such as bronchial asthma or airway hyperreactivity.
- Patients with allergies to ultrasound gel.
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 |
|---|---|---|
| Distance between Skin-Hyoid Bone(DSHB)Hyoid bone-skin distance Other Name: DSHB | Diagnostic test | 2-8 Years Paediatric Patients |
| Distance between Skin-Vocal Cord Anterior Commissura(DSAC)Vocal cord anterior commissura-skin distance Other Name: DSAC | Diagnostic test | 2-8 Years Paediatric Patients |
| Distance between Skin-Epiglottic(DSE)Skin-epiglottic distance Other Name: DSE | Diagnostic test | 2-8 Years Paediatric Patients |
Primary outcome
Difficult laryngoscopy
Time frame: 1 minute
As the primary outcome, correlation of distance between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure and skin (DSAC), and distance between the epiglottis and skin (DSE) and A/E (Anterior Commissura/Epiglottis) ratio with the Cormack Lehane score will be evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Background: PubMed 25403231Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
- Background: PubMed 31742568Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
- Background: PubMed 32730647Altun D, Kara H, Bozbora E, Ali A, Dinc T, Sonmez S, Buget M, Aydemir L, Basaran B, Tugrul M, Camci E. The Role of Indirect Laryngoscopy, Clinical and Ultrasonographic Assessment in Prediction of Difficult Airway. Laryngoscope. 2021 Feb;131(2):E555-E560. doi: 10.1002/lary.28849. Epub 2020 Jul 30.
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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.
Osman Kaya, Res Assist. principal investigator
Eskisehir Osmangazi 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 Intubation; Difficult or Failed and Difficult Laryngoscopy, run by Eskisehir Osmangazi 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 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: finished, as of the sponsor's last update on 16 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difficult laryngoscopy (time frame: 1 minute). 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 NCT05833347, which also lists 3 linked publications.
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 16 Feb 2024.