Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

Anesthesia Clinical Trial

— PeDiAC  

Official title:

Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844723
• Other study ID #: 2021-10380-BO-ff
• Status: Completed
• Start date: April 12, 2021
• Est. completion date: August 3, 2022

Study information

• Verified date: August 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 809
• Est. completion date: August 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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