- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03641157
Predicting Difficult Airway in Children
Value of BMI and Anthropometric Measurements With CL Test in Predicting Difficult Laryngoscopy in Children
Background: Obtaining airway security holds the utmost importance in anesthesia. Specific predictive tests or findings for difficult airway are not defined for various pediatric age groups. Anthropometric measurements are defined parallel to percentile curves in different age groups.
Aim: The aim of this study is to find out the value of body mass index and anthropometric measurements in prediction of difficult laryngoscopy in children by comparing to direct laryngoscopic evaluation of Cormack-Lehane test.
Methods: Following institutional ethics committee approval and informed consent of parents of 108 patients (ages 0-3years), undergoing elective surgery were included in this study. Weight, height, body mass index and head circumference of the patients were measured and percentiles were recorded, prior to induction.
Following standard anesthesia induction with thiopental all patients received 0,6 mg.kg-1 rocuronium intravenously. After sufficient time for neuromuscular relaxation laryngoscopy performed and Cormack-Lehane scores recorded. All recorded parameters were compared with Cormack-Lehane scores.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Izmir, Turkey
- Tepecik Education and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 0-3 years old (1-36 mounts) pediatric patients
- Patients 0-3 age years old with ASA I, undergoing elective surgery were included in this study
Exclusion Criteria:
- Patients with known syndrome, facial anomaly, ASA score above 2 and laryngeal mask aiway were excluded from the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group I Easy Intubation
Pediatric patients ages 0-3 years Easy Intubation (Cormach-Lehane score I-II)
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Other Names:
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Group II Difficult intubation
Pediatric patients ages 0-3 years Difficult intubation (Cormach-Lehane score III-IV)
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difficult laryngoscopy classification using Cormack-LehaneGrade Assessment of difficult laryngoscopy at the time of the airway management procedure.
Time Frame: immediate
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Classified as Grade I-visualization of entire laryngeal aperture, grade II-visualization of only posterior commissure of laryngeal aperture, grade III-visualization of only epiglottis, grade IV-visualization of just the soft palate.
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immediate
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Head circumference measured in cm with a measuring tape.
Time Frame: immediate
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Head circumference were taken at the level above eyebrows and ears and measured in cm with a measuring tape.
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immediate
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Weight measured in kilogram with electronic scale.
Time Frame: immediate
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Weight measured using electronic scale (0-20 kg) while undressed and without diapers .
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immediate
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Height measured in cm with infantometer.
Time Frame: immediate
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Height measured using a portable infantometer (0-100 cm) while the child was in supine position.
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immediate
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BMI was calculated as kg/m2.
Time Frame: immediate
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BMI measured using a weight/height2 formul
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immediate
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Percentage values measured in % with percentile tables.
Time Frame: immediate
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Percentage (%) values using from the percentile tables of Turkish children were determined after the head circumference (cm), height (cm), weight (kg) and BMI (kg/m2) values of all pediatric cases were determined as described above.
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immediate
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Collaborators and Investigators
Investigators
- Study Director: PERVIN BOZKURT, Prof, Tepecik Education and Research Hospital
Publications and helpful links
General Publications
- Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Schmidt J. Incidence and predictors of difficult laryngoscopy in 11,219 pediatric anesthesia procedures. Paediatr Anaesth. 2012 Aug;22(8):729-36. doi: 10.1111/j.1460-9592.2012.03813.x. Epub 2012 Feb 20.
- Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Cesnjevar R, Schmidt J. Incidence and predictors of poor laryngoscopic view in children undergoing pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Jun;27(3):516-21. doi: 10.1053/j.jvca.2012.08.019. Epub 2012 Oct 17.
- 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.
- Mansano AM, Modolo NS, Silva LM, Ganem EM, Braz LG, Knabe Ade C, Freitas FM. Bedside tests to predict laryngoscopic difficulty in pediatric patients. Int J Pediatr Otorhinolaryngol. 2016 Apr;83:63-8. doi: 10.1016/j.ijporl.2016.01.031. Epub 2016 Feb 3.
- Mirghassemi A, Soltani AE, Abtahi M. Evaluation of laryngoscopic views and related influencing factors in a pediatric population. Paediatr Anaesth. 2011 Jun;21(6):663-7. doi: 10.1111/j.1460-9592.2011.03555.x. Epub 2011 Mar 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GAYDIN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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