Clinical trial NCT04844723: Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification
Official title: Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Complication of Anesthesia
Intubation;Difficult
Anesthesia
Laryngoscopy
Airway Management
Keywords: Children
Airway management
Videolaryngoscopy
Endotracheal Intubation
Difficult Intubation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 809
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive sampling: Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.
* Informed consent obtained
* Age \< 18 years

Exclusion Criteria:

* Anesthetist prefers conventional laryngoscopy
* Indication for intubation via a bronchoscope or awake intubation

Primary outcomes:
measure: Difficult videolaryngoscopic intubation
timeFrame: 1 hour
Secondary outcomes:
measure: First pass success rate
timeFrame: 1 hour
measure: Overall success rate with the first-choice technique
timeFrame: 1 hour
measure: Number of attempts
timeFrame: 1 hour
measure: Change of airway technique
timeFrame: 1 hour
measure: Best glottic view
timeFrame: 1 hour
measure: Time to best view
timeFrame: 1 hour
measure: Intubation time
timeFrame: 1 hour
measure: Intubation difficulty, ease of intubation and quality of visualisation
timeFrame: 1 hour
measure: Post-intubation recommendation for an intubation method
timeFrame: 1 hour
measure: Post-intubation recommendation for an anesthesia alert cart
timeFrame: 1 hour
measure: Post-intubation diagnosis of 'difficult intubation'
timeFrame: 1 hour
measure: Airway-related adverse events
timeFrame: 1 hour
measure: Difficult bag-mask ventilation
timeFrame: 1 hour
measure: Lowest oxygen saturation
timeFrame: 1 hour
measure: Hypercapnia
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Martin Petzoldt, MD
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Thorsten W Dohrmann, MD
role: STUDY_CHAIR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Christian Zöllner, MD
role: STUDY_CHAIR
References: