Difficult AirwayDiffairNCT03404453
Difficult Airway Prediction in Paediatric Anaesthesia
An observational study of Difficult Airway, run by Brno University Hospital at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 28 days to 19 years
- Conditions the study is for
- Difficult Airway
- What is being tested?
- Difficult airway incidence and prediction
- How many people
- 399 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2018to 1 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 19 years
- All sexes
- Child, Adult
Study population: Paediatric patients at the preanaesthetic examination, scheduled for surgery under general anaesthesia
Who may be able to join
- All paediatric patients scheduled for surgery under general anaesthesia On the preanaesthetic examination
Who cannot join
- Airway already secured by tracheostomy Surgery without securing the airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Difficult Airway Prediction in Paediatric Anaesthesia:Prospective Observational Trial
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.
- Conditions
- Difficult Airway
- Being tested
- Difficult airway incidence and prediction
- Keywords
- Airway prediction, Difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difficult airway incidence and predictionDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Paediatric patients at preanaesthetic visi | Difficult airway incidence and prediction:Paediatric patients at preanaesthetic visit scheduled for surgery under general anaesthesia Receives: Diagnostic Test: Difficult airway incidence and prediction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: during anaesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Jan 2018
- Primary completion30 Jun 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404453
- Sponsor's protocol ID
- KDAR FN Brno Airway 2018
- Acronym
- Diffair
- Status last verified
- Nov 2018
- First submitted
- 12 Jan 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difficult Airway Prediction in Paediatric Anaesthesia:Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT03404453
- Acronym / sponsor ID
- Diffair / KDAR FN Brno Airway 2018
- Conditions
- Difficult Airway
- Keywords
- Airway prediction, Difficult airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients at preanaesthetic visi | – | Diagnostic Test: Difficult airway incidence and predictionDifficult airway incidence and prediction:Paediatric patients at preanaesthetic visit scheduled for surgery under general anaesthesia |
Who may qualify
- Ages
- 28 days to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Paediatric patients at the preanaesthetic examination, scheduled for surgery under general anaesthesia
Key inclusion criteria (1 listed)
- All paediatric patients scheduled for surgery under general anaesthesia On the preanaesthetic examination
Key exclusion criteria (1 listed)
- Airway already secured by tracheostomy Surgery without securing the airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Difficult airway incidence and predictionPaediatric 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 | Diagnostic test | Paediatric patients at preanaesthetic visi |
Primary outcome
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.
1 secondary outcome
Predictability of difficult airway
Time frame: during anaesthesia induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Airway, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of difficult airway in paediatric patients under general anaesthesia (time frame: during anaesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.