Clinical trial NCT03641157: Predicting Difficult Airway in Children
Official title: Value of BMI and Anthropometric Measurements With CL Test in Predicting Difficult Laryngoscopy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Intubation
Pediatrics
Keywords: Difficult intubation
Pediatrics
predictive tests
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Demographic data, head circumference, weight, height measurements, body mass index and percentile values were recorded by a pediatric surgeon who was unaware about the studyin the preoperative period.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difficult laryngoscopy classification using Cormack-LehaneGrade Assessment of difficult laryngoscopy at the time of the airway management procedure.
timeFrame: immediate
Secondary outcomes:
measure: Head circumference measured in cm with a measuring tape.
timeFrame: immediate
measure: Weight measured in kilogram with electronic scale.
timeFrame: immediate
measure: Height measured in cm with infantometer.
timeFrame: immediate
measure: BMI was calculated as kg/m2.
timeFrame: immediate
measure: Percentage values measured in % with percentile tables.
timeFrame: immediate
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Tepecik Education and Research Hospital
Study officials:
affiliation: Tepecik Education and Research Hospital
name: PERVIN BOZKURT, Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.