An observational study in Airway Complication of Anesthesia, Intubation;Difficult and Anesthesia, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2022-08-23.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
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.
Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive sampling: Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.
Exclusion Criteria:
Difficult videolaryngoscopic intubation
Rating by the responsible anesthetist
Time frame: 1 hour
First pass success rate
Percentage of successful intubations with one attempt
Time frame: 1 hour
Overall success rate with the first-choice technique
Percentage of successful intubations without transition to another technique
Time frame: 1 hour
Number of attempts
Total number of laryngoscopy and intubation attempts until airway established
Time frame: 1 hour
Change of airway technique
Transition to a different technique, i.e. flexible bronchoscopy, surgical airway, supraglottic airway as clinically assessed (Yes/No)
Time frame: 1 hour
Best glottic view
Best view on the larynx obtained during laryngoscopy assessed by Cormack/Lehane classification (grade I to IV)
Time frame: 1 hour
Time to best view
Time until optimal view conditions during laryngoscopy
Time frame: 1 hour
Intubation time
Time until successful tracheal intubation
Time frame: 1 hour
Intubation difficulty, ease of intubation and quality of visualisation
Subjective ratings on visual analogue scales (0 to 100 with 0 being the best)
Time frame: 1 hour
Post-intubation recommendation for an intubation method
Requirement of recommendation for further intubations of the responsible anesthetist
Time frame: 1 hour
Post-intubation recommendation for an anesthesia alert cart
Recommendation of the responsible anesthetist (yes/no)
Time frame: 1 hour
Post-intubation diagnosis of 'difficult intubation'
Rating of the responsible anesthetist
Time frame: 1 hour
Airway-related adverse events
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
Difficult bag-mask ventilation
As clinically assessed (yes/no) by the responsible anesthetist
Time frame: 1 hour
Lowest oxygen saturation
Measured with pulsoxymetry during anesthesia
Time frame: 1 hour
Hypercapnia
Measured endtidal carbon dioxide after successful intubation
Time frame: 1 hour
Plan to share: No
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf