Intubation; DifficultSWIVIT INCT01692535
Evaluation of Video Laryngoscopes in Difficult Airway
A study testing Intubation in people with Intubation; Difficult, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
Trial summary
In this multicenter study the investigators are going to evaluate the use of six different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Jan 2013to Jun 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective surgery with general anesthesia requiring intubation
- >18years old
- ASA I-III
Who cannot join
- known or presumed difficult airway
- risk of pulmonary aspiration
- refusing to participate
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Bern University Hospital and University of Bern
Bern, Canton of Bern, 3011
Hopitaux Universitaires de Geneve HUG
Geneva, Canton of Geneva
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Canton of Vaud
About this study
Official title: Multicenter Study Evaluating Video Laryngoscopes: The Swiss Video-Intubation Trial (SWIVIT I)
In this multicenter study the investigators are going to evaluate the use of six different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these six videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As gold standard, a standard Macintosh blade is being used.
The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720 patients.
- Conditions
- Intubation; Difficult
- Being tested
- Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationProcedure or surgery
Intubation with one of the six videolaryngoscopes
| Study group | Role | What they receive |
|---|---|---|
| GlideScope | Experimental | intubation Receives: Procedure: Intubation |
| Airtraq | Experimental | intubation Receives: Procedure: Intubation |
| McGrath MAC | Experimental | intubation Receives: Procedure: Intubation |
| King Vision | Experimental | intubation Receives: Procedure: Intubation |
| A.P. Advance | Experimental | intubation Receives: Procedure: Intubation |
| C-MAC | Experimental | intubation Receives: Procedure: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt intubation success rate
Measured: within 180 seconds
Secondary outcomes (1)
side effects
sore throat, bleeding, dental injuries
Measured: 1h and 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionJun 2015
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 Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenz Theiler, Insel Gruppe AG, University Hospital Bern
- Investigators
- Robert Greif, MD MME FERC, Study chair, University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692535
- Sponsor's protocol ID
- 106/12
- Acronym
- SWIVIT I
- Status last verified
- Jun 2015
- First submitted
- 17 Sep 2012
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kleine-Brueggeney M, Greif R, Schoettker P, Savoldelli GL, Nabecker S, Theiler LG. Evaluation of six videolaryngoscopes in 720 patients with a simulated difficult airway: a multicentre randomized controlled trial. Br J Anaesth. 2016 May;116(5):670-9. doi: 10.1093/bja/aew058.
PubMed 27106971Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94.
PubMed 23556410
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study Evaluating Video Laryngoscopes: The Swiss Video-Intubation Trial (SWIVIT I)
- ClinicalTrials.gov ID
- NCT01692535
- Acronym / sponsor ID
- SWIVIT I / 106/12
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Sep 2012 (estimated)
- 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.
In this multicenter study the investigators are going to evaluate the use of six different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these six videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As gold standard, a standard Macintosh blade is being used.
The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720 patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GlideScope | Experimental | Procedure: Intubationintubation |
| Airtraq | Experimental | Procedure: Intubationintubation |
| McGrath MAC | Experimental | Procedure: Intubationintubation |
| King Vision | Experimental | Procedure: Intubationintubation |
| A.P. Advance | Experimental | Procedure: Intubationintubation |
| C-MAC | Experimental | Procedure: Intubationintubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective surgery with general anesthesia requiring intubation
- >18years old
- ASA I-III
Key exclusion criteria (3 listed)
- known or presumed difficult airway
- risk of pulmonary aspiration
- refusing to participate
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 |
|---|---|---|
| IntubationIntubation with one of the six videolaryngoscopes | Procedure or surgery | A.P. Advance, Airtraq, C-MAC, GlideScope, King Vision, McGrath MAC |
Primary outcome
First attempt intubation success rate
Time frame: within 180 seconds
1 secondary outcome
side effects
Time frame: 1h and 1 day 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 11 Jun 2015.
- Derived from this study: PubMed 27106971Kleine-Brueggeney M, Greif R, Schoettker P, Savoldelli GL, Nabecker S, Theiler LG. Evaluation of six videolaryngoscopes in 720 patients with a simulated difficult airway: a multicentre randomized controlled trial. Br J Anaesth. 2016 May;116(5):670-9. doi: 10.1093/bja/aew058.
- Derived from this study: PubMed 23556410Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94.
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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.
Robert Greif, MD MME FERC study chair
University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation in people with Intubation; Difficult, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
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 3 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 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
First attempt intubation success rate (time frame: within 180 seconds). 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 NCT01692535, 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 11 Jun 2015.