Difficult Airway Prediction in Paediatric Anaesthesia

Completed

• Conditions: Difficult Airway
• Interventions: Diagnostic Test: Difficult airway incidence and prediction

• Registration Number: NCT03404453
• Lead Sponsor: Brno University Hospital

Brief Summary

The incidence of difficult airway in paediatric population is up-to date not well described. Difficult airway is connected with significant airway-related morbidity and mortality. The majority of difficult airway in paediatric patients should be predictable. The aim of the study is to evaluate the incidence of difficult airway in paediatric patients scheduled for surgery under general anaesthesia and to test the predictability of the set of prediction tests to reveal the patients with high risk of difficult airway.

Detailed Description

At the preanaesthetic visit the paediatric patients will be examined for difficult airway. The Mallampati score, interincisor garp, cervical spine mobility, upper lip bite test and thyromental distance will be measured. The distances will be measured in centimeters and the width of the distal part of the third finger will be measured to obtain the distance according to the patients fingers. The airway management plan will be defined and the incidence of the difficult airway (difficult face mask ventilation - two hand, two operators, desaturation, difficult intubation - Cormack-Leehane 3-4, intubation on 3 and more attempts, difficult laryngeal mask insertion and the incidence of cannot intubate cannot ventilate scenario will be evaluated. The predictability of the test for difficult airway prediction (Cormack-Leehane 3-4, cannot-intubate - cannot ventilate scenario, difficult mask ventilation) will be statistically analyzed.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-19
• Primary Completion: 2018-06-30
• Status Verified: 2018-11
• Study Completion: 2018-11-01
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

Inclusion Criteria

• All paediatric patients scheduled for surgery under general anaesthesia On the preanaesthetic examination

Exclusion Criteria

• Airway already secured by tracheostomy Surgery without securing the airway

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paediatric patients at preanaesthetic visi	Difficult airway incidence and prediction	Difficult airway incidence and prediction:Paediatric patients at preanaesthetic visit scheduled for surgery under general anaesthesia

Primary Outcome Measures

Name	Time	Method
Incidence of difficult airway in paediatric patients under general anaesthesia	during anaesthesia induction	The incidence of the difficult airway will be evaluated by the anaesthesiologist in the operating room. Difficult airway will be considered as difficult face mask ventilation, difficult intubation (Cormack-Leehane 3 and 4, intubation at 3 and over 3rd attempt), difficult laryngeal mask insertion (more than 2 attempts) and the presence of the cannot intubate - cannot ventilate scenario.

Secondary Outcome Measures

Name	Time	Method
Predictability of difficult airway	during anaesthesia induction	At the preanaesthetic examination a set of difficult airway prediction tests will be performed and the predictability of difficult airway will be evaluated by the statistical analysis

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, Czechia