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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03641157
Other study ID # GAYDIN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 11, 2014
Est. completion date July 11, 2016

Study information

Verified date August 2018
Source Tepecik Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date July 11, 2016
Est. primary completion date July 11, 2016
Accepts healthy volunteers
Gender All
Age group 1 Month to 36 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Easy Intubation


Locations

Country Name City State
Turkey Tepecik Education and Research Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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.jvc — View 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 — View 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. — View Citation

Mansano AM, Módolo 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Difficult laryngoscopy classification using Cormack-LehaneGrade Assessment of difficult laryngoscopy at the time of the airway management procedure. 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. immediate
Secondary Head circumference measured in cm with a measuring tape. Head circumference were taken at the level above eyebrows and ears and measured in cm with a measuring tape. immediate
Secondary Weight measured in kilogram with electronic scale. Weight measured using electronic scale (0-20 kg) while undressed and without diapers . immediate
Secondary Height measured in cm with infantometer. Height measured using a portable infantometer (0-100 cm) while the child was in supine position. immediate
Secondary BMI was calculated as kg/m2. BMI measured using a weight/height2 formul immediate
Secondary Percentage values measured in % with percentile tables. 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. immediate
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