University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
NCT Number: NCT04844723
The study's primary aim is to develop and validate a multivariable diagnostic model for the prediction of difficult videolaryngoscopy (the 'PeDiAC classification') in children undergoing general anesthesia with tracheal intubation. The secondary aim is to compare the diagnostic performance of the PeDiAC-classification with the Cormack-Lehane classification.
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Notify MeUp to 18 year
All sexes
Observational
Hamburg, 20246, Germany
Difficult tracheal intubation is one of the major reasons for anesthesia-related adverse events. Videolaryngoscopy has become an important part of the anesthesiology standard of care for difficult airway management in the past decades. This is especially relevant in children, as their airway anatomy differs greatly from adults because they are likely incapable of tolerating brief apneic episodes. Still, medical preconditions and procedural and technical factors related to difficult videolaryngoscopy have not been broadly investigated and not fully been understood.
The primary aim of the PeDiAC study is to develop and validate a multivariable diagnostic model for the classification of difficult videolaryngoscopy (the 'PeDiAC classification') in children undergoing general anesthesia with tracheal intubation. Study planning and conduction are in accordance with the TRIPOD 'Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis' statement. The secondary aim is to compare the diagnostic performance of the PeDiAC-classification with the Cormack-Lehane classification, which is the current clinical standard for assessing intubation via direct laryngoscopy. We conduct a prospective observational study that will include approximately 800 pediatric patients within one year scheduling for tracheal intubation. Patients with age below 18 years will be considered to be eligible for inclusion. Procedural and surgical data, as well as medical preconditions, will be assessed systematically. After tracheal intubation, performed by the responsible anesthetist, the intubation process will be rated by the responsible anesthetist and an additional independent observer, and detailed information regarding procedural and technical factors related to videolaryngoscopy will be documented. All sampled independent variables will be considered to be potential candidate predictors for the multivariable regression model.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 hour
Rating by the responsible anesthetist
Time frame: 1 hour
Percentage of successful intubations with one attempt
Time frame: 1 hour
Percentage of successful intubations without transition to another technique
Time frame: 1 hour
Total number of laryngoscopy and intubation attempts until airway established
Time frame: 1 hour
Transition to a different technique, i.e. flexible bronchoscopy, surgical airway, supraglottic airway as clinically assessed (Yes/No)
Time frame: 1 hour
Best view on the larynx obtained during laryngoscopy assessed by Cormack/Lehane classification (grade I to IV)
Time frame: 1 hour
Time until optimal view conditions during laryngoscopy
Time frame: 1 hour
Time until successful tracheal intubation
Time frame: 1 hour
Subjective ratings on visual analogue scales (0 to 100 with 0 being the best)
Time frame: 1 hour
Requirement of recommendation for further intubations of the responsible anesthetist
Time frame: 1 hour
Recommendation of the responsible anesthetist (yes/no)
Time frame: 1 hour
Rating of the responsible anesthetist
Time frame: 1 hour
Laryngospasm, bronchospasm, larynx trauma, airway trauma, soft tissue trauma, oral bleeding, edema, dental damage, corticosteroid application, accidental esophageal intubation, aspiration, hypotension or hypoxia
Time frame: 1 hour
As clinically assessed (yes/no) by the responsible anesthetist
Time frame: 1 hour
Measured with pulsoxymetry during anesthesia
Time frame: 1 hour
Measured endtidal carbon dioxide after successful intubation
Universitätsklinikum Hamburg-Eppendorf
Other
Acronym: PeDiAC
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