Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

NCT ID: NCT04844723

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 809 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2022-08-03

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Petzoldt, MD

Role: STUDY_DIRECTOR

Universitätsklinikum Hamburg-Eppendorf

Thorsten W Dohrmann, MD

Role: STUDY_CHAIR

Universitätsklinikum Hamburg-Eppendorf

Christian Zöllner, MD

Role: STUDY_CHAIR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

Other Identifiers

2021-10380-BO-ff

Identifier Type: -

Identifier Source: org_study_id