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Completed

NCT Number: NCT03404453

Difficult Airway Prediction in Paediatric Anaesthesia

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.

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Key information

Conditions

Difficult Airway

Age range

28 day–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brno University Hospital

Brno, 62500, Czechia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Difficult airway incidence and prediction

Diagnostic Test

Paediatric patients scheduled for surgery under general anaesthesia will be examined and a set up of airway prediction tests will be performed to predict the possibility of difficult airway

Primary outcomes

  1. Incidence of difficult airway in paediatric patients under general anaesthesia

    Time frame: 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 outcomes

  1. Predictability of difficult airway

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

Difficult Airway Prediction in Paediatric Anaesthesia:Prospective Observational Trial

Acronym: Diffair

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 19, 2018
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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