Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients

NCT ID: NCT05833347

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-01-04

Brief Summary

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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

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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.

Conditions

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Intubation; Difficult or Failed Difficult Laryngoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Distance between Skin-Hyoid Bone(DSHB)

Intervention Type DIAGNOSTIC_TEST

Hyoid bone-skin distance Other Name: DSHB

Distance between Skin-Vocal Cord Anterior Commissura(DSAC)

Intervention Type DIAGNOSTIC_TEST

Vocal cord anterior commissura-skin distance Other Name: DSAC

Distance between Skin-Epiglottic(DSE)

Intervention Type DIAGNOSTIC_TEST

Skin-epiglottic distance Other Name: DSE

Interventions

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Distance between Skin-Hyoid Bone(DSHB)

Hyoid bone-skin distance Other Name: DSHB

Intervention Type DIAGNOSTIC_TEST

Distance between Skin-Vocal Cord Anterior Commissura(DSAC)

Vocal cord anterior commissura-skin distance Other Name: DSAC

Intervention Type DIAGNOSTIC_TEST

Distance between Skin-Epiglottic(DSE)

Skin-epiglottic distance Other Name: DSE

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients planned to undergo general anesthesia for elective surgery
* American Anesthesiology Association physical classification (ASA) status I-III
* Body mass index (BMI) above 30

Exclusion Criteria

* 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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Osman Kaya

Trainee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osman Kaya, Res Assist.

Role: PRINCIPAL_INVESTIGATOR

Eskisehir Osmangazi University

Locations

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Eskisehir Osmangazi University

Eskişehir, Eskişehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25403231 (View on PubMed)

Alessandri 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.

Reference Type BACKGROUND
PMID: 31742568 (View on PubMed)

Altun 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.

Reference Type BACKGROUND
PMID: 32730647 (View on PubMed)

Other Identifiers

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ESOGU-OKAYA-001

Identifier Type: -

Identifier Source: org_study_id

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