Difficult Airway Prediction in Paediatric Anaesthesia

Difficult Airway Clinical Trial

— Diffair  

Official title:

Difficult Airway Prediction in Paediatric Anaesthesia:Prospective Observational Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404453
• Other study ID #: KDAR FN Brno Airway 2018
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: November 1, 2018
• Est. primary completion date: June 30, 2018
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Airway

Intervention

Diagnostic Test:
• Difficult airway incidence and prediction
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

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of difficult airway in paediatric patients under general anaesthesia	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.	during anaesthesia induction
Secondary	Predictability of difficult airway	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	during anaesthesia induction