Intubation; Difficult or FailedNCT05522049
Videolaryngoscopic Intubation Using Macintosh vs.Hyperangulated Blades in Patients With Expected Difficult Intubation
A study testing hyperangulated videolaryngoscope and Macintosh videolaryngoscope in people with Intubation; Difficult or Failed and Videolaryngoscopy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Videolaryngoscopy-guided intubation has become widespread as a means of preventing major complications relating to airway management by improving the glottic view, increasing the first attempt success rate, likely reduce rates of hypoxemic events, while reducing the rate of airway trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult or Failed, Videolaryngoscopy, General Anesthesia
- What is being tested?
- hyperangulated videolaryngoscope and Macintosh videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteGermany
- Study dates
- 17 Oct 2022to 31 Jul 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patients requiring general anesthesia with transoral tracheal intubation for elective ear, nose and throat or maxillofacial surgery
- Expected difficult intubation
- Age ≥ 18
Who cannot join
- Pregnant or breastfeeding woman
- Planned awake tracheal intubation (without deep anesthesia or neuromuscular blocking agents)
- Required transnasal tracheal intubation (e.g. for surgical reasons)
- Special tubes required for surgical reasons ( e.g. double lumen tube)
- Denial of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Videolaryngoscopy-guided Intubation Using Macintosh Versus Hyperangulated Blades in Patients With Expected Difficult Intubation Undergoing Ear, Nose and Throat Surgery or Maxillofacial Surgery a Randomized Controlled Trial
Videolaryngoscopy-guided intubation has become widespread as a means of preventing major complications relating to airway management by improving the glottic view, increasing the first attempt success rate, likely reduce rates of hypoxemic events, while reducing the rate of airway trauma. However, as randomized controlled studies in patients with anticipated difficult intubation undergoing ear nose and throat (ENT) or oral and maxillofacial (OMF) surgery are lacking, it is still unknown if hyperangulated blades improve glottic view and if their use translates into faster intubation. The primary aim of this randomized controlled trial is to compare the percentage of glottic opening (POGO) between hyperangulated blades and Macintosh blades in patients with expected difficult intubation undergoing ENT or OMF surgery who require transoral tracheal intubation. Secondary aims are to compare secondary outcome measures such as time variables, indicators for difficult and successful intubation, number of attempts, view conditions, difficult airway classifications and adverse events between both blade types.
- Being tested
- hyperangulated videolaryngoscope, Macintosh videolaryngoscope
- Keywords
- Airway management, Hyperangulated blade, Macintosh blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperangulated videolaryngoscopeDevice
Also called C-MAC D-Blade, Storz
Intubation using a hyperangulated videolaryngoscope
Macintosh videolaryngoscopeDevice
Also called C-MAC, Storz
Intubation using a Macintosh videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Tracheal intubation facilitated by a hyperangulated videolaryngoscope (C-MAC D-Blade) Receives: Device: hyperangulated videolaryngoscope |
| Control group | Active comparator | Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade (C-MAC) Receives: Device: Macintosh videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of glottic opening (POGO)
Grading of the best view obtained during laryngoscopy (%)
Measured: 1 hour
Secondary outcomes (16)
Time to successful tracheal intubation (seconds)
Recorded during airway management
Measured: 1 hour
Time to successful first attempt intubation (seconds)
Recorded during airway management
Measured: 1 hour
Cormack-Lehane grade
Grading of the best view obtained during laryngoscopy (I [best] to IV [worst])
Measured: 1 hour
Impaired view (vocal cords cannot be visualized by laryngoscopy)
Number of participants with impaired view observed during airway management
Measured: 1 hour
Difficult laryngoscopy
Number of participants with difficult laryngoscopy as defined in current guidelines
Measured: 1 hour
Difficult intubation
Number of participants with difficult tracheal intubation as defined in current guidelines
Measured: 1 hour
Transition to a different tracheal intubation technique
Number of participants in whom the airway operator decided to convert to an alternative intubation technique
Measured: 1 hour
Tracheal introducer
Number of participants in whom the airway operator decided to use a tracheal introducer
Measured: 1 hour
Successful first attempt
Number of participants with successful tracheal intubation with only one attempt
Measured: 1 hour
Overall success of intubation
Number of participants with successful tracheal intubation regardless of the the number of attempts
Measured: 1 hour
Difficulty of videolaryngoscope-guided intubation
VIDIAC (Videolaryngoscopic Intubation and Difficult Airway Classification) Score from -1 (best) to 5 (worst)
Measured: 1 hour
Number of intubation attempts
Observed during airway management
Measured: 1 hour
Number of laryngoscopy attempts
Observed during airway management
Measured: 1 hour
Airway related adverse events
Number of participants with airway related adverse events observed during airway management
Measured: 1 hour
Hypoxaemia
Number of participants with a drop in peripheral oxygen saturation during airway management
Measured: 1 hour
Hypotension
Number of participants with hypotension observed during airway management
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 posted30 Aug 2022
- Study start17 Oct 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Petzoldt, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522049
- Sponsor's protocol ID
- 2022-100868-BO-ff
- Status last verified
- Sep 2023
- First submitted
- 22 Aug 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videolaryngoscopy-guided Intubation Using Macintosh Versus Hyperangulated Blades in Patients With Expected Difficult Intubation Undergoing Ear, Nose and Throat Surgery or Maxillofacial Surgery a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05522049
- Acronym / sponsor ID
- 2022-100868-BO-ff
- Keywords
- Airway management, Hyperangulated blade, Macintosh blade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 30 Aug 2022 (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.
Videolaryngoscopy-guided intubation has become widespread as a means of preventing major complications relating to airway management by improving the glottic view, increasing the first attempt success rate, likely reduce rates of hypoxemic events, while reducing the rate of airway trauma. However, as randomized controlled studies in patients with anticipated difficult intubation undergoing ear nose and throat (ENT) or oral and maxillofacial (OMF) surgery are lacking, it is still unknown if hyperangulated blades improve glottic view and if their use translates into faster intubation. The primary aim of this randomized controlled trial is to compare the percentage of glottic opening (POGO) between hyperangulated blades and Macintosh blades in patients with expected difficult intubation undergoing ENT or OMF surgery who require transoral tracheal intubation. Secondary aims are to compare secondary outcome measures such as time variables, indicators for difficult and successful intubation, number of attempts, view conditions, difficult airway classifications and adverse events between both blade types.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: hyperangulated videolaryngoscopeTracheal intubation facilitated by a hyperangulated videolaryngoscope (C-MAC D-Blade) |
| Control group | Active comparator | Device: Macintosh videolaryngoscopeTracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade (C-MAC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring general anesthesia with transoral tracheal intubation for elective ear, nose and throat or maxillofacial surgery
- Expected difficult intubation
- Age ≥ 18
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding woman
- Planned awake tracheal intubation (without deep anesthesia or neuromuscular blocking agents)
- Required transnasal tracheal intubation (e.g. for surgical reasons)
- Special tubes required for surgical reasons ( e.g. double lumen tube)
- Denial of consent
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 |
|---|---|---|
| hyperangulated videolaryngoscopeAlso: C-MAC D-Blade, StorzIntubation using a hyperangulated videolaryngoscope | Device | Intervention group |
| Macintosh videolaryngoscopeAlso: C-MAC, StorzIntubation using a Macintosh videolaryngoscope | Device | Control group |
Primary outcome
Percentage of glottic opening (POGO)
Time frame: 1 hour
Grading of the best view obtained during laryngoscopy (%)
16 secondary outcomes
Time to successful tracheal intubation (seconds)
Time frame: 1 hour
Time to successful first attempt intubation (seconds)
Time frame: 1 hour
Cormack-Lehane grade
Time frame: 1 hour
Impaired view (vocal cords cannot be visualized by laryngoscopy)
Time frame: 1 hour
Difficult laryngoscopy
Time frame: 1 hour
Difficult intubation
Time frame: 1 hour
Transition to a different tracheal intubation technique
Time frame: 1 hour
Tracheal introducer
Time frame: 1 hour
Successful first attempt
Time frame: 1 hour
Overall success of intubation
Time frame: 1 hour
Difficulty of videolaryngoscope-guided intubation
Time frame: 1 hour
Number of intubation attempts
Time frame: 1 hour
Number of laryngoscopy attempts
Time frame: 1 hour
Airway related adverse events
Time frame: 1 hour
Hypoxaemia
Time frame: 1 hour
Hypotension
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 26 Sep 2023.
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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 principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperangulated videolaryngoscope and Macintosh videolaryngoscope in people with Intubation; Difficult or Failed and Videolaryngoscopy, 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 5 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 26 Sep 2023. 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?
Percentage of glottic opening (POGO) (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 26 Sep 2023.