Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 809

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive sampling: Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficult videolaryngoscopic intubation	Rating by the responsible anesthetist	1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Study Chair: Christian Zöllner, MD, Universitätsklinikum Hamburg-Eppendorf; Study Director: Martin Petzoldt, MD, Universitätsklinikum Hamburg-Eppendorf; Study Chair: Thorsten W Dohrmann, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): August 3, 2022
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Children; Difficult Intubation; Videolaryngoscopy; Airway management; Endotracheal Intubation
• Other Study ID Numbers: 2021-10380-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No