- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07115407
- Original Trial
Validation of the POGO Score for Classification of Videolaryngoscopy in Children - Post-hoc Analysis of the PeDiAC Study (POGO-KIDS)
August 3, 2025 updated by: Universitätsklinikum Hamburg-Eppendorf
External Validation of the POGO Score for Classification of Videolaryngoscopic Intubation in Children and Comparison With the Quality of the Glottic View Rated on Visual Analogue Scales - Post-hoc Analysis of the Prospective PeDiAC Study
It has been assumed that the percentage of glottic opening (POGO) score might enhance the classification of videolaryngoscopic tracheal intubation by offering a more objective rating of glottic exposure but studies in children are lacking.
This post hoc analysis of the prospective observational PeDiAC study aims to investigate, if classifying difficult videolaryngoscopic tracheal intubation with the POGO score is superior to a subjective rating of the quality of the glottic view on visual analogue scales (VAS).
Post hoc video analysis will be performed by multiple independent raters.
A secondary aim is to determine the diagnostic performance of the POGO and VAS for the prediction of relevant user- and patient-centered outcomes and to assess the inter-rater reliability of the POGO score.
Study Overview
Status
Active, not recruiting
Study Type
Observational
Enrollment (Actual)
809
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hamburg, Germany, 20246
- Department of Anesthesiology, Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Consecutive sampling: Pediatric patients undergoing general anesthesia with videolaryngoscopic 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difficult videolaryngoscopic intubation
Time Frame: 1 hour
|
Defined as a difficult airway alert issued by the airway operator following videolaryngoscopy
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multiple laryngoscopy attempts
Time Frame: 1 hour
|
More than one laryngoscopy attempt required until airway established
|
1 hour
|
|
Multiple tracheal intubation attempts
Time Frame: 1 hour
|
More than one tracheal intubation attempt until airway established
|
1 hour
|
|
First attempt success rate
Time Frame: 1 hour
|
Percentage of successful intubations with one attempt at laryngoscopy and intubation
|
1 hour
|
|
Percentage of glottic opening (POGO) score
Time Frame: 1 hour
|
Best glottic view obtained during videolaryngoscopy assessed with the POGO score (%)
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1 hour
|
|
Quality of glottic visualization
Time Frame: 1 hour
|
Subjective ratings on visual analog scales (0 to 100; higher values indicate better glottic view)
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1 hour
|
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Tracheal intubation time
Time Frame: 1 hour
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Time until successful tracheal intubation
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1 hour
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Airway-related adverse events
Time Frame: 1 hour
|
Laryngospasm; bronchospasm; airway, oral, soft tissue or dental trauma; laryngeal swelling or use of corticosteroids to reduce swelling risk; oesophageal intubation; pulmonary aspiration; and severe hypoxaemia
|
1 hour
|
|
Difficulty of videolaryngoscopic tracheal intubation
Time Frame: 1 hour
|
Difficulty of videolaryngoscopic tracheal intubation assessed by the PeDiAC score (0-8; higher values indicate increased difficulty)
|
1 hour
|
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Severe hypoxaemia
Time Frame: 1 hour
|
Oxygen saturation < 70% or hypoxaemia-related bradycardia
|
1 hour
|
|
Prolonged tracheal intubation
Time Frame: 1 hour
|
Tracheal intubation time > 90 sec
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Martin Petzoldt, MD, Universitätsklinikum Hamburg-Eppendorf
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2021
Primary Completion (Actual)
August 3, 2022
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
August 3, 2025
First Submitted That Met QC Criteria
August 3, 2025
First Posted (Actual)
August 11, 2025
Study Record Updates
Last Update Posted (Actual)
August 11, 2025
Last Update Submitted That Met QC Criteria
August 3, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2025-300614-WF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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