NCT03641157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

March 31, 2018

Last Update Submit

August 17, 2018

Conditions

Keywords

Difficult intubationPediatricspredictive tests

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Head circumference measured in cm with a measuring tape.

    immediate

  • Weight measured in kilogram with electronic scale.

    immediate

  • Height measured in cm with infantometer.

    immediate

  • BMI was calculated as kg/m2.

    immediate

  • Percentage values measured in % with percentile tables.

    immediate

Study Arms (2)

Group I Easy Intubation

Pediatric patients ages 0-3 years Easy Intubation (Cormach-Lehane score I-II)

Other: Easy Intubation

Group II Difficult intubation

Pediatric patients ages 0-3 years Difficult intubation (Cormach-Lehane score III-IV)

Other: Easy Intubation

Interventions

Also known as: Difficult intubation
Group I Easy IntubationGroup II Difficult intubation

Eligibility Criteria

Age1 Month - 36 Months
Sexall(Gender-based eligibility)
Gender Eligibility Detailspediatric patients
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • years old (1-36 mounts) pediatric patients
  • Patients 0-3 age years old with ASA I, undergoing elective surgery were included in this study

You may not qualify if:

  • Patients with known syndrome, facial anomaly, ASA score above 2 and laryngeal mask aiway were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Education and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (5)

  • 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 Officials

  • PERVIN BOZKURT, Prof

    Tepecik Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Clinic, principal investigator, Clinical Associated Professor

Study Record Dates

First Submitted

March 31, 2018

First Posted

August 21, 2018

Study Start

July 11, 2014

Primary Completion

July 11, 2016

Study Completion

July 11, 2016

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Value of BMI and Anthropometric Measurements with CL Test in Predicting Difficult Laryngoscopy in Children

Locations