Oral SurgeryVIDiACNCT03950934
Videolaryngoscopic Intubation and Difficult Airway Classification
An observational study of Oral Surgery and Maxillofacial Surgery, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Primary aim of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing oral and maxillofacial (OMF) or ear, nose and throat (ENT) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Surgery, Maxillofacial Surgery
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 1 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ENT or OMF surgical patients presenting at the Anesthesiology Preassessment Clinic of the University Medical Center Hamburg-Eppendorf for preoperative risk assessment will be checked for eligibility. Repeated inclusions of participators are allowed.
Who may be able to join
- 18 Years and older
- Patients scheduling for ENT or OMF surgery under general anesthesia with requirement of endotracheal Intubation
- Risk of difficult airway management with confirmed indication for videolaryngoscopic intubation
Who cannot join
- No consent given
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Classification and Prediction of Difficult Videolaryngoscopic Intubation in Patients Undergoing Oral and Maxillofacial or Ear, Nose and Throat Surgery
Primary aim of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing oral and maxillofacial (OMF) or ear, nose and throat (ENT) surgery. Furthermore, this study intends to assess the diagnostic value of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.
Read the detailed description
Difficult endotracheal intubation is a major reason for anesthesia related adverse events. Videolaryngoscopy has become an important part of the anesthesiological standard of care for difficult airway management in the past decades. Still, medical preconditions, as well as procedural and technical factors related with difficult videolaryngoscopy have not been systematically investigated, and a standardized comprehensive classification system for the severity of videolaryngoscopic intubation has yet to be specified. The primary objective of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing ENT or OMF surgery.
Patients with conditions of the ENT and OMF spectrum have a predisposition for difficult airway management and are at high risk for adverse events during endotracheal intubation. However, current recommendations for preoperative screening for difficult intubation rarely consider space consuming lesions of the laryngopharyngeal region. Comprehensive data identifying the predictive value of preoperative flexible nasal videoendoscopy as a diagnostic measure to anticipate difficult airway management still lack. Thus, secondary aim of this study is to evaluate the diagnostic value and clinical significance of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.
Study design:
The investigators conduct a prospective observational study, which includes 400 patients with predicted difficult airway and confirmed indication for flexible nasal videoendoscopy and videolaryngoscopic intubation undergoing ENT or OMF surgery.
Procedural and surgical data as well as medical preconditions will be assessed systematically. The handling anesthetist and two independent observers will be surveyed (structured questionnaire) in order to assess procedural and technical factors related with videolaryngoscopic intubation.
- Conditions
- Oral Surgery, Maxillofacial Surgery
- Being tested
- no intervention, observational study, perioperative survey
- Keywords
- Anesthesia, Airway Management, Intubation, Bronchoscopes, Risk Assessment, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, observational study, perioperative surveyOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult videolaryngoscopic intubation
Questionnaire
Measured: 30 minutes after endotracheal intubation
Secondary outcomes (12)
Successful first intubation attempt
Observation during airway management
Measured: 30 minutes after endotracheal intubation
Overall success
Observation during airway management
Measured: 30 minutes after endotracheal intubation
Unsuccessful videolaryngoscopy
Observation during airway management
Measured: 30 minutes after endotracheal intubation
Severity of videolaryngoscopic intubation
Numeral rating scale
Measured: 30 minutes after endotracheal intubation
Specific recommendations of the handling anesthetist
Questionnaire
Measured: 30 minutes after endotracheal intubation
Time to successful intubation
Observation during airway management
Measured: 30 minutes after endotracheal intubation
Number of laryngoscopy and intubation attempts
Observation during airway management
Measured: 30 minutes after endotracheal intubation
Lowest oxygen saturation during airway management
Observation during airway management
Measured: 30 minutes after endotracheal intubation
Initial end-tidal carbon dioxide level after successful intubation
Observation during airway management
Measured: 30 minutes after endotracheal intubation
Observed complications during or after induction of general anesthesia
Questionnaire
Measured: 30 minutes after endotracheal intubation
Length of hospital stay
Follow-up
Measured: Until hospital discharge up to 3 months after surgery
All cause in-hospital mortality
Follow-up
Measured: Until hospital discharge up to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Apr 2019
- Primary completion5 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral SurgeryStudies of the same condition, open and under way.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Petzoldt, PD Dr., Principal investigator, Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950934
- Sponsor's protocol ID
- PV5856
- Acronym
- VIDiAC
- Status last verified
- May 2020
- First submitted
- 13 May 2019
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peters T, Wunsch VA, Siebert H, Kohl V, Breitfeld P, Dankert A, Sasu PB, Dohrmann T, Krause L, Zollner C, Petzoldt M. What Is a Critical Mouth Opening for Macintosh Videolaryngoscopy? Results From a Prospective Observational Study. Anesth Analg. 2026 Sep 1;143(3):578-587. doi: 10.1213/ANE.0000000000007838. Epub 2025 Oct 30.
PubMed 41452604Wunsch VA, Kohl V, Breitfeld P, Bauer M, Sasu PB, Siebert HK, Dankert A, Stark M, Zollner C, Petzoldt M. Hyperangulated blades or direct epiglottis lifting to optimize glottis visualization in difficult Macintosh videolaryngoscopy: a non-inferiority analysis of a prospective observational study. Front Med (Lausanne). 2023 Nov 30;10:1292056. doi: 10.3389/fmed.2023.1292056. eCollection 2023.
PubMed 38098848
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification and Prediction of Difficult Videolaryngoscopic Intubation in Patients Undergoing Oral and Maxillofacial or Ear, Nose and Throat Surgery
- ClinicalTrials.gov ID
- NCT03950934
- Acronym / sponsor ID
- VIDiAC / PV5856
- Conditions
- Oral Surgery, Maxillofacial Surgery
- Keywords
- Anesthesia, Airway Management, Intubation, Bronchoscopes, Risk Assessment, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 15 May 2019 (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.
Primary aim of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing oral and maxillofacial (OMF) or ear, nose and throat (ENT) surgery. Furthermore, this study intends to assess the diagnostic value of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.
Detailed description
Difficult endotracheal intubation is a major reason for anesthesia related adverse events. Videolaryngoscopy has become an important part of the anesthesiological standard of care for difficult airway management in the past decades. Still, medical preconditions, as well as procedural and technical factors related with difficult videolaryngoscopy have not been systematically investigated, and a standardized comprehensive classification system for the severity of videolaryngoscopic intubation has yet to be specified. The primary objective of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing ENT or OMF surgery.
Patients with conditions of the ENT and OMF spectrum have a predisposition for difficult airway management and are at high risk for adverse events during endotracheal intubation. However, current recommendations for preoperative screening for difficult intubation rarely consider space consuming lesions of the laryngopharyngeal region. Comprehensive data identifying the predictive value of preoperative flexible nasal videoendoscopy as a diagnostic measure to anticipate difficult airway management still lack. Thus, secondary aim of this study is to evaluate the diagnostic value and clinical significance of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.
Study design:
The investigators conduct a prospective observational study, which includes 400 patients with predicted difficult airway and confirmed indication for flexible nasal videoendoscopy and videolaryngoscopic intubation undergoing ENT or OMF surgery.
Procedural and surgical data as well as medical preconditions will be assessed systematically. The handling anesthetist and two independent observers will be surveyed (structured questionnaire) in order to assess procedural and technical factors related with videolaryngoscopic intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ENT or OMF surgical patients presenting at the Anesthesiology Preassessment Clinic of the University Medical Center Hamburg-Eppendorf for preoperative risk assessment will be checked for eligibility. Repeated inclusions of participators are allowed.
Key inclusion criteria (3 listed)
- 18 Years and older
- Patients scheduling for ENT or OMF surgery under general anesthesia with requirement of endotracheal Intubation
- Risk of difficult airway management with confirmed indication for videolaryngoscopic intubation
Key exclusion criteria (2 listed)
- No consent given
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, observational study, perioperative surveyno intervention | Other | – |
Primary outcome
Difficult videolaryngoscopic intubation
Time frame: 30 minutes after endotracheal intubation
Questionnaire
12 secondary outcomes
Successful first intubation attempt
Time frame: 30 minutes after endotracheal intubation
Overall success
Time frame: 30 minutes after endotracheal intubation
Unsuccessful videolaryngoscopy
Time frame: 30 minutes after endotracheal intubation
Severity of videolaryngoscopic intubation
Time frame: 30 minutes after endotracheal intubation
Specific recommendations of the handling anesthetist
Time frame: 30 minutes after endotracheal intubation
Time to successful intubation
Time frame: 30 minutes after endotracheal intubation
Number of laryngoscopy and intubation attempts
Time frame: 30 minutes after endotracheal intubation
Lowest oxygen saturation during airway management
Time frame: 30 minutes after endotracheal intubation
Initial end-tidal carbon dioxide level after successful intubation
Time frame: 30 minutes after endotracheal intubation
Observed complications during or after induction of general anesthesia
Time frame: 30 minutes after endotracheal intubation
Length of hospital stay
Time frame: Until hospital discharge up to 3 months after surgery
All cause in-hospital mortality
Time frame: Until hospital discharge up to 3 months after surgery
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 29 May 2020.
- Derived from this study: PubMed 41452604Peters T, Wunsch VA, Siebert H, Kohl V, Breitfeld P, Dankert A, Sasu PB, Dohrmann T, Krause L, Zollner C, Petzoldt M. What Is a Critical Mouth Opening for Macintosh Videolaryngoscopy? Results From a Prospective Observational Study. Anesth Analg. 2026 Sep 1;143(3):578-587. doi: 10.1213/ANE.0000000000007838. Epub 2025 Oct 30.
- Derived from this study: PubMed 38098848Wunsch VA, Kohl V, Breitfeld P, Bauer M, Sasu PB, Siebert HK, Dankert A, Stark M, Zollner C, Petzoldt M. Hyperangulated blades or direct epiglottis lifting to optimize glottis visualization in difficult Macintosh videolaryngoscopy: a non-inferiority analysis of a prospective observational study. Front Med (Lausanne). 2023 Nov 30;10:1292056. doi: 10.3389/fmed.2023.1292056. eCollection 2023.
- 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, PD Dr. principal investigator
Department of Anesthesiology, University Medical Center 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 Oral Surgery and Maxillofacial Surgery, 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 29 May 2020. 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: 30 minutes after endotracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950934, which also lists 2 linked publications.
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 29 May 2020.