NCT03404453

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

January 12, 2018

Last Update Submit

November 16, 2018

Conditions

Keywords

Airway predictionDifficult airway

Outcome Measures

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.

    during anaesthesia induction

Secondary Outcomes (1)

  • Predictability of difficult airway

    during anaesthesia induction

Study Arms (1)

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

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

Paediatric patients at preanaesthetic visi

Eligibility Criteria

Age28 Days - 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- Airway already secured by tracheostomy Surgery without securing the airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital

Brno, 62500, Czechia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doc.MD.Ph.D

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 19, 2018

Study Start

January 1, 2018

Primary Completion

June 30, 2018

Study Completion

November 1, 2018

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations