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CompletedNCT03404453DiffairUpdated Nov 19, 2018

Difficult Airway Prediction in Paediatric Anaesthesia

An observational study in Difficult Airway, sponsored by Brno University Hospital. Completed at 1 site in Czechia. Open to participants aged 28 Days to 19 Years. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by Brno University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
399
Ages
28 Days to 19 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Difficult Airway

Keywords

  • Airway prediction
  • Difficult airway
03

Who can participate

Ages eligible
28 Days to 19 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Paediatric patients at the preanaesthetic examination, scheduled for surgery under general anaesthesia

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Airway already secured by tracheostomy Surgery without securing the airway
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
399 participants (actual)
Patient registry
No

Groups and cohorts

  • Paediatric patients at preanaesthetic visi

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

    Diagnostic Test: Difficult airway incidence and prediction

Interventions

  • Diagnostic testDifficult 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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: during anaesthesia induction

Secondary outcomes

  1. 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

    Time frame: during anaesthesia induction

06

Study locations

1 site
  • Brno University Hospital
    Brno, 62500, Czechia
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03404453
Lead sponsor
Brno University Hospital
Responsible party
Petr Štourač, MD (doc.MD.Ph.D, Brno University Hospital) — Principal investigator
First posted
Jan 19, 2018
Start date
Jan 1, 2018
Primary completion
Jun 30, 2018
Completion
Nov 1, 2018
Last update
Nov 19, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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