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Completed

NCT Number: NCT04844723

Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difficult videolaryngoscopic intubation

    Time frame: 1 hour

    Rating by the responsible anesthetist

Secondary outcomes

  1. First pass success rate

    Time frame: 1 hour

    Percentage of successful intubations with one attempt

  2. Overall success rate with the first-choice technique

    Time frame: 1 hour

    Percentage of successful intubations without transition to another technique

  3. Number of attempts

    Time frame: 1 hour

    Total number of laryngoscopy and intubation attempts until airway established

  4. Change of airway technique

    Time frame: 1 hour

    Transition to a different technique, i.e. flexible bronchoscopy, surgical airway, supraglottic airway as clinically assessed (Yes/No)

  5. Best glottic view

    Time frame: 1 hour

    Best view on the larynx obtained during laryngoscopy assessed by Cormack/Lehane classification (grade I to IV)

  6. Time to best view

    Time frame: 1 hour

    Time until optimal view conditions during laryngoscopy

  7. Intubation time

    Time frame: 1 hour

    Time until successful tracheal intubation

  8. Intubation difficulty, ease of intubation and quality of visualisation

    Time frame: 1 hour

    Subjective ratings on visual analogue scales (0 to 100 with 0 being the best)

  9. Post-intubation recommendation for an intubation method

    Time frame: 1 hour

    Requirement of recommendation for further intubations of the responsible anesthetist

  10. Post-intubation recommendation for an anesthesia alert cart

    Time frame: 1 hour

    Recommendation of the responsible anesthetist (yes/no)

  11. Post-intubation diagnosis of 'difficult intubation'

    Time frame: 1 hour

    Rating of the responsible anesthetist

  12. Airway-related adverse events

    Time frame: 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

  13. Difficult bag-mask ventilation

    Time frame: 1 hour

    As clinically assessed (yes/no) by the responsible anesthetist

  14. Lowest oxygen saturation

    Time frame: 1 hour

    Measured with pulsoxymetry during anesthesia

  15. Hypercapnia

    Time frame: 1 hour

    Measured endtidal carbon dioxide after successful intubation

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: PeDiAC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2021
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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