NCT04844723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
809

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

April 13, 2021

Last Update Submit

August 22, 2022

Conditions

Airway Complication of AnesthesiaIntubation;DifficultAnesthesiaLaryngoscopyAirway Management

Keywords

ChildrenAirway managementVideolaryngoscopyEndotracheal IntubationDifficult Intubation

Outcome Measures

Primary Outcomes (1)

  • Difficult videolaryngoscopic intubation

    Rating by the responsible anesthetist

    1 hour

Secondary Outcomes (15)

  • First pass success rate

    1 hour

  • Overall success rate with the first-choice technique

    1 hour

  • Number of attempts

    1 hour

  • Change of airway technique

    1 hour

  • Best glottic view

    1 hour

  • +10 more secondary outcomes

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.
  • Informed consent obtained
  • Age \< 18 years

You may not qualify if:

  • Anesthetist prefers conventional laryngoscopy
  • Indication for intubation via a bronchoscope or awake intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Study Officials

  • Martin Petzoldt, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY DIRECTOR

  • Thorsten W Dohrmann, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

  • Christian Zöllner, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 14, 2021

Study Start

April 12, 2021

Primary Completion

August 3, 2022

Study Completion

August 3, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)