Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

Completed

• Conditions: Airway Complication of Anesthesia; Laryngoscopy; Intubation;Difficult; Airway Management; Anesthesia

• Registration Number: NCT04844723
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2021-04-12
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-14
• Status Verified: 2022-08
• Primary Completion: 2022-08-03
• Study Completion: 2022-08-03
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 809

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difficult videolaryngoscopic intubation	1 hour	Rating by the responsible anesthetist

Secondary Outcome Measures

Name	Time	Method
Hypercapnia	1 hour	Measured endtidal carbon dioxide after successful intubation
Change of airway technique	1 hour	Transition to a different technique, i.e. flexible bronchoscopy, surgical airway, supraglottic airway as clinically assessed (Yes/No)
Number of attempts	1 hour	Total number of laryngoscopy and intubation attempts until airway established
Post-intubation diagnosis of 'difficult intubation'	1 hour	Rating of the responsible anesthetist
Airway-related adverse events	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
Difficult bag-mask ventilation	1 hour	As clinically assessed (yes/no) by the responsible anesthetist
Lowest oxygen saturation	1 hour	Measured with pulsoxymetry during anesthesia
Post-intubation recommendation for an anesthesia alert cart	1 hour	Recommendation of the responsible anesthetist (yes/no)
First pass success rate	1 hour	Percentage of successful intubations with one attempt
Overall success rate with the first-choice technique	1 hour	Percentage of successful intubations without transition to another technique
Intubation difficulty, ease of intubation and quality of visualisation	1 hour	Subjective ratings on visual analogue scales (0 to 100 with 0 being the best)
Best glottic view	1 hour	Best view on the larynx obtained during laryngoscopy assessed by Cormack/Lehane classification (grade I to IV)
Time to best view	1 hour	Time until optimal view conditions during laryngoscopy
Intubation time	1 hour	Time until successful tracheal intubation
Post-intubation recommendation for an intubation method	1 hour	Requirement of recommendation for further intubations of the responsible anesthetist

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany