Airway Complication of AnesthesiaPeDiACNCT04844723
Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification
An observational study of Airway Complication of Anesthesia and Intubation;Difficult, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Airway Complication of Anesthesia, Intubation;Difficult, Anesthesia
- How many people
- 809 participants
- Where
- 1 siteGermany
- Study dates
- 12 Apr 2021to 3 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Consecutive sampling: Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.
Who may be able to join
- Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.
- Informed consent obtained
- Age < 18 years
Who cannot join
- Anesthetist prefers conventional laryngoscopy
- Indication for intubation via a bronchoscope or awake intubation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- Children, Airway management, Videolaryngoscopy, Endotracheal Intubation, Difficult Intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult videolaryngoscopic intubation
Rating by the responsible anesthetist
Measured: 1 hour
Secondary outcomes (15)
First pass success rate
Percentage of successful intubations with one attempt
Measured: 1 hour
Overall success rate with the first-choice technique
Percentage of successful intubations without transition to another technique
Measured: 1 hour
Number of attempts
Total number of laryngoscopy and intubation attempts until airway established
Measured: 1 hour
Change of airway technique
Transition to a different technique, i.e. flexible bronchoscopy, surgical airway, supraglottic airway as clinically assessed (Yes/No)
Measured: 1 hour
Best glottic view
Best view on the larynx obtained during laryngoscopy assessed by Cormack/Lehane classification (grade I to IV)
Measured: 1 hour
Time to best view
Time until optimal view conditions during laryngoscopy
Measured: 1 hour
Intubation time
Time until successful tracheal intubation
Measured: 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)
Measured: 1 hour
Post-intubation recommendation for an intubation method
Requirement of recommendation for further intubations of the responsible anesthetist
Measured: 1 hour
Post-intubation recommendation for an anesthesia alert cart
Recommendation of the responsible anesthetist (yes/no)
Measured: 1 hour
Post-intubation diagnosis of 'difficult intubation'
Rating of the responsible anesthetist
Measured: 1 hour
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
Measured: 1 hour
Difficult bag-mask ventilation
As clinically assessed (yes/no) by the responsible anesthetist
Measured: 1 hour
Lowest oxygen saturation
Measured with pulsoxymetry during anesthesia
Measured: 1 hour
Hypercapnia
Measured endtidal carbon dioxide after successful intubation
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start12 Apr 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 809 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Petzoldt, MD, Study director, Universitätsklinikum Hamburg-EppendorfThorsten W Dohrmann, MD, Study chair, Universitätsklinikum Hamburg-EppendorfChristian Zöllner, MD, Study chair, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844723
- Sponsor's protocol ID
- 2021-10380-BO-ff
- Acronym
- PeDiAC
- Status last verified
- Aug 2022
- First submitted
- 13 Apr 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification
- ClinicalTrials.gov ID
- NCT04844723
- Acronym / sponsor ID
- PeDiAC / 2021-10380-BO-ff
- Conditions
- Airway Complication of Anesthesia, Intubation;Difficult, Anesthesia, Laryngoscopy, Airway Management
- Keywords
- Children, Airway management, Videolaryngoscopy, Endotracheal Intubation, Difficult Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 809 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Consecutive sampling: Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.
Key inclusion criteria (3 listed)
- Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.
- Informed consent obtained
- Age < 18 years
Key exclusion criteria (2 listed)
- Anesthetist prefers conventional laryngoscopy
- Indication for intubation via a bronchoscope or awake intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difficult videolaryngoscopic intubation
Time frame: 1 hour
Rating by the responsible anesthetist
15 secondary outcomes
First pass success rate
Time frame: 1 hour
Overall success rate with the first-choice technique
Time frame: 1 hour
Number of attempts
Time frame: 1 hour
Change of airway technique
Time frame: 1 hour
Best glottic view
Time frame: 1 hour
Time to best view
Time frame: 1 hour
Intubation time
Time frame: 1 hour
Intubation difficulty, ease of intubation and quality of visualisation
Time frame: 1 hour
Post-intubation recommendation for an intubation method
Time frame: 1 hour
Post-intubation recommendation for an anesthesia alert cart
Time frame: 1 hour
Post-intubation diagnosis of 'difficult intubation'
Time frame: 1 hour
Airway-related adverse events
Time frame: 1 hour
Difficult bag-mask ventilation
Time frame: 1 hour
Lowest oxygen saturation
Time frame: 1 hour
Hypercapnia
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Petzoldt, MD study director
Universitätsklinikum Hamburg-Eppendorf
Thorsten W Dohrmann, MD study chair
Universitätsklinikum Hamburg-Eppendorf
Christian Zöllner, MD study chair
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia and Intubation;Difficult, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficult videolaryngoscopic intubation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.