Difficult IntubationSWIVITIINCT02088801
Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
A study testing Airtraq, blade without channel for tracheal tube intubation, KingVision , blade without channel for tracheal tube intubation and A.P. Advance, blade without channel for tracheal tube intubation in people with Difficult Intubation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In this second phase of the multicenter study the investigators are going to evaluate the use of three different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Airtraq, blade without channel for tracheal tube intubation, KingVision , blade without channel for tracheal tube intubation and A.P. Advance, blade without channel for tracheal tube intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective surgery with general anesthesia requiring intubation
- >18 years old
- ASA I-III
Who cannot join
- known or presumed difficult airway
- risk of pulmonary aspiration
- refusing to participate
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bern University Hospital and University of Bern
Bern, Canton of Bern, 3011
About this study
Official title: Phase 2 Study of Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
In this second phase of the multicenter study the investigators are going to evaluate the use of three different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these three videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As the gold standard, a standard Macintosh blade is being used for comparison.
The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480 patients.
- Conditions
- Difficult Intubation
- Being tested
- Airtraq, blade without channel for tracheal tube intubation, KingVision , blade without channel for tracheal tube intubation, A.P. Advance, blade without channel for tracheal tube intubation, Macintosh
- Keywords
- Intubation; Difficult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airtraq, blade without channel for tracheal tube intubationDevice
Also called Airtraq, A.P. Advance, KingVision, Macintosh
Intubation
KingVision , blade without channel for tracheal tube intubationDevice
A.P. Advance, blade without channel for tracheal tube intubationDevice
MacintoshDevice
| Study group | Role | What they receive |
|---|---|---|
| Airtraq, blade without channel for tracheal tube | Experimental | intubation Receives: Device: Airtraq, blade without channel for tracheal tube intubation |
| KingVision , blade without channel for tracheal tube | Experimental | intubation Receives: Device: KingVision , blade without channel for tracheal tube intubation |
| A.P. Advance, blade without channel for tracheal tube | Experimental | intubation Receives: Device: A.P. Advance, blade without channel for tracheal tube intubation |
| Macintosh | Experimental | intubation Receives: Device: Macintosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
first attempt intubation success rate
Measured: intraoperative
Secondary outcomes (1)
side effects
sore throat, bleeding, dental injuries
Measured: 1h and 1day after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- 480 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, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088801
- Sponsor's protocol ID
- 106/12_2
- Other IDs
- SWIVIT II
- Acronym
- SWIVITII
- Status last verified
- Jun 2015
- First submitted
- 11 Mar 2014
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Phase 2 Study of Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
- ClinicalTrials.gov ID
- NCT02088801
- Acronym / sponsor ID
- SWIVITII / 106/12_2
- Conditions
- Difficult Intubation
- Keywords
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Mar 2014 (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 second phase of the multicenter study the investigators are going to evaluate the use of three different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these three videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As the gold standard, a standard Macintosh blade is being used for comparison.
The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480 patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Airtraq, blade without channel for tracheal tube | Experimental | Device: Airtraq, blade without channel for tracheal tube intubationintubation |
| KingVision , blade without channel for tracheal tube | Experimental | Device: KingVision , blade without channel for tracheal tube intubationintubation |
| A.P. Advance, blade without channel for tracheal tube | Experimental | Device: A.P. Advance, blade without channel for tracheal tube intubationintubation |
| Macintosh | Experimental | Device: Macintoshintubation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective surgery with general anesthesia requiring intubation
- >18 years 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 |
|---|---|---|
| Airtraq, blade without channel for tracheal tube intubationAlso: Airtraq, A.P. Advance, KingVision, MacintoshIntubation | Device | Airtraq, blade without channel for tracheal tube |
| KingVision , blade without channel for tracheal tube intubation | Device | KingVision , blade without channel for tracheal tube |
| A.P. Advance, blade without channel for tracheal tube intubation | Device | A.P. Advance, blade without channel for tracheal tube |
| Macintosh | Device | Macintosh |
Primary outcome
first attempt intubation success rate
Time frame: intraoperative
1 secondary outcome
side effects
Time frame: 1h and 1day after intubation
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.
Related trials for Difficult Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
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
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airtraq, blade without channel for tracheal tube intubation, KingVision , blade without channel for tracheal tube intubation and A.P. Advance, blade without channel for tracheal tube intubation in people with Difficult Intubation, run by Insel Gruppe AG, University Hospital Bern at 1 site 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 1 site 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: intraoperative). 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 11 Jun 2015.