Airway ManagementNCT05044416
VieScope in Patients With an Expected Difficult Airway
A study testing VieScope and Videolaryngoscopy in people with Airway Management, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) VieScope or b) videolaryngoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- VieScope and Videolaryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2021to 26 Jun 2022
- 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 surgery
- Age ≥ 18
- Preoperative airway assessment reveals an expected difficult airway (rated by the responsible anesthetist in the Pre-assessment Clinic based on the existing in-house algorithm)
Who cannot join
- Pregnant or breastfeeding woman
- Confirmed indications for awake fiberoptic intubation especially due to enoral, pharyngeal tumors, abscesses or other processes
- Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
- Required transnasal tracheal intubation (e.g. for surgical reasons)
- Requirement of special endotracheal tubes such as laser or RAE tubes for surgical reasons
- Patients at risk for pulmonary aspiration who qualify for rapid sequence induction
- Loose teeth
- Denial of consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: Tracheal Intubation With VieScope Versus Videolaryngoscopy in Patients for Elective Surgery With an Expected Difficult Airway - a Prospective Randomized Trial (VieScOP-II)
Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) VieScope or b) videolaryngoscopy.
Read the detailed description
Tracheal intubation is required for different surgical procedures for mechanical ventilation and to prevent aspiration of secretions. In patients with an expected difficult airway, tracheal intubation is often performed by videolaryngoscopy (VL). However, this technique has limitations and may fail due to insufficient visualization of the larynx. A new device has been introduced that consists of an illuminated straight plastic tube for laryngoscopy (VSC, Vie Scope, Adroit Surgical, Oklahoma City, OK, USA) that enables for indirect intubation over a stylet.
So far, the VSC has shown promising results in manikin studies for intubation in normal and difficult airways. We aim to test the VSC in patients compared to videolaryngoscopy in a prospective randomized non-inferiority trial.
Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the University Medical Center Hamburg-Eppendorf prior to elective surgery. All patients receive a structured preoperative airway assessment.
Patients are randomized 1:1 to either intervention or control group. Patients randomized to the intervention group will be intubated with the VSC. Patients randomized to the control group are intubated with a MacIntosh type videolaryngoscope (CMAC, Storz, Germany).
- Conditions
- Airway Management
- Being tested
- VieScope, Videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VieScopeDevice
intubation with VieScope laryngoscope
VideolaryngoscopyDevice
intubation with videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| VieScope | Experimental | intubation with the VieScope laryngoscope Receives: Device: VieScope |
| Videolaryngoscopy | Active comparator | intubation with videolaryngoscope Receives: Device: Videolaryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Glottis Opening (POGO) scale
intubating conditions according to the percentage of glottis opening scale (POGO), range 0-100%, higher values better
Measured: 15 min
Secondary outcomes (11)
first attempt success rate
percentage of successful intubations with one attempt
Measured: 15 min
time to intubation
time until tracheal airway access is established
Measured: 15 min
Cormack-Lehane
intubating conditions according to Cormack-Lehane
Measured: 15 min
overall success rate
percentage of successful intubations with the allocated procedure
Measured: 15 min
time to successful intubation with one attempt
time until tracheal airway access is established in patients that are intubated at first attempt
Measured: 15 min
intubation difficulty
subjective rating on a visual analogue scale (0-100, higher values indicate more difficult intubation) of the difficulty of airway management and questionnaire
Measured: 15 min
number of attempts
total number of attempts until airway established
Measured: 15 min
aspiration
percentage of patients that vomit and aspirate during intubation
Measured: 15 min
esophageal intubation
percentage of accidental esophageal intubation attempts
Measured: 15 min
hypoxia
percentage of patients with a desaturation below a pulsoximetric saturation of 80%
Measured: 15 min
hypotension
percentage of patients with a systolic blood pressure below 70 mmHg
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start11 Sep 2021
- Primary completion26 Jun 2022
- Study completion26 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized 1:1
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joern Grensemann, MD, Study chair, Universitätsklinikum Hamburg-EppendorfMartin Petzoldt, MD, Study chair, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044416
- Sponsor's protocol ID
- VieScOP-II
- Status last verified
- Jun 2022
- First submitted
- 5 Sep 2021
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Petzoldt M, Grun C, Wunsch VA, Bauer M, Hardel TT, Grensemann J. Vie Scope(R) versus videolaryngoscopy in expected difficult airways: a randomized controlled trial. Can J Anaesth. 2023 Sep;70(9):1486-1494. doi: 10.1007/s12630-023-02534-y. Epub 2023 Aug 3.
PubMed 37537324
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Intubation With VieScope Versus Videolaryngoscopy in Patients for Elective Surgery With an Expected Difficult Airway - a Prospective Randomized Trial (VieScOP-II)
- ClinicalTrials.gov ID
- NCT05044416
- Acronym / sponsor ID
- VieScOP-II
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 26 Jun 2022 (actual)
- Study completion
- 26 Jun 2022 (actual)
- First posted
- 14 Sep 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.
Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) VieScope or b) videolaryngoscopy.
Detailed description
Tracheal intubation is required for different surgical procedures for mechanical ventilation and to prevent aspiration of secretions. In patients with an expected difficult airway, tracheal intubation is often performed by videolaryngoscopy (VL). However, this technique has limitations and may fail due to insufficient visualization of the larynx. A new device has been introduced that consists of an illuminated straight plastic tube for laryngoscopy (VSC, Vie Scope, Adroit Surgical, Oklahoma City, OK, USA) that enables for indirect intubation over a stylet.
So far, the VSC has shown promising results in manikin studies for intubation in normal and difficult airways. We aim to test the VSC in patients compared to videolaryngoscopy in a prospective randomized non-inferiority trial.
Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the University Medical Center Hamburg-Eppendorf prior to elective surgery. All patients receive a structured preoperative airway assessment.
Patients are randomized 1:1 to either intervention or control group. Patients randomized to the intervention group will be intubated with the VSC. Patients randomized to the control group are intubated with a MacIntosh type videolaryngoscope (CMAC, Storz, Germany).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| VieScope | Experimental | Device: VieScopeintubation with the VieScope laryngoscope |
| Videolaryngoscopy | Active comparator | Device: Videolaryngoscopyintubation with videolaryngoscope |
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 surgery
- Age ≥ 18
- Preoperative airway assessment reveals an expected difficult airway (rated by the responsible anesthetist in the Pre-assessment Clinic based on the existing in-house algorithm)
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding woman
- Confirmed indications for awake fiberoptic intubation especially due to enoral, pharyngeal tumors, abscesses or other processes
- Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
- Required transnasal tracheal intubation (e.g. for surgical reasons)
- Requirement of special endotracheal tubes such as laser or RAE tubes for surgical reasons
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 |
|---|---|---|
| VieScopeintubation with VieScope laryngoscope | Device | VieScope |
| Videolaryngoscopyintubation with videolaryngoscope | Device | Videolaryngoscopy |
Primary outcome
Percentage of Glottis Opening (POGO) scale
Time frame: 15 min
intubating conditions according to the percentage of glottis opening scale (POGO), range 0-100%, higher values better
11 secondary outcomes
first attempt success rate
Time frame: 15 min
time to intubation
Time frame: 15 min
Cormack-Lehane
Time frame: 15 min
overall success rate
Time frame: 15 min
time to successful intubation with one attempt
Time frame: 15 min
intubation difficulty
Time frame: 15 min
number of attempts
Time frame: 15 min
aspiration
Time frame: 15 min
esophageal intubation
Time frame: 15 min
hypoxia
Time frame: 15 min
hypotension
Time frame: 15 min
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 1 Jul 2022.
- Derived from this study: PubMed 37537324Petzoldt M, Grun C, Wunsch VA, Bauer M, Hardel TT, Grensemann J. Vie Scope(R) versus videolaryngoscopy in expected difficult airways: a randomized controlled trial. Can J Anaesth. 2023 Sep;70(9):1486-1494. doi: 10.1007/s12630-023-02534-y. Epub 2023 Aug 3.
- Individual participant dataSharing planned: Undecided
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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.
Joern Grensemann, MD study chair
Universitätsklinikum Hamburg-Eppendorf
Martin Petzoldt, 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?
A study testing VieScope and Videolaryngoscopy in people with Airway Management, 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 8 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 1 Jul 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?
Percentage of Glottis Opening (POGO) scale (time frame: 15 min). 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 NCT05044416, which also lists 1 linked publication.
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 1 Jul 2022.