Airway MorbiditySensaScopeNCT02348736
Comparison of SensaScope Intuboscope and McGrath Series 5 for Endotracheal Intubation
A study testing Time for tracheal intubation in people with Airway Morbidity, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
A randomized controlled prospective study of laryngoscopy and intubation time comparing SensaScope and the McGrath® Series 5 video laryngoscope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- Time for tracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 Years No concurrent participation in another study
- capacity to consent
- Present written informed consent of the research participant
- Elective surgery under general anesthesia
Who cannot join
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
- Emergency situations in the context of a Difficult Airway Management
Show all 9Show fewer
- ASA classification> 3
- situations where the possibility of accumulated gastric contents
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Comparative Study Between SensaScope Intuboscope and McGrath Series 5 Videolaryngoscope to Tracheal Intubation: a Prospective Randomised Study
A randomized controlled prospective study of laryngoscopy and intubation time comparing SensaScope and the McGrath® Series 5 video laryngoscope.
Read the detailed description
The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to semi-rigid stylet. An national, mono center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® Series 5 versus SensaScope in adult patients under general anaesthesia.
- Conditions
- Airway Morbidity
- Being tested
- Time for tracheal intubation
- Keywords
- airway, videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time for tracheal intubationDevice
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
| Study group | Role | What they receive |
|---|---|---|
| SensaScope | Experimental | Time for tracheal intubation with the SensaScope Receives: Device: Time for tracheal intubation |
| McGrath Series 5 | Experimental | Time for tracheal intubation with the McGrath Series 5 Receives: Device: Time for tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of different time for tracheal intubation
times for tracheal intubation, View of the glottic, experience in anesthesia
Measured: <2min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Airway MorbidityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, Principal investigator, University JG, Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348736
- Sponsor's protocol ID
- JohannesGUM
- Acronym
- SensaScope
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2015
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Negishi Y, Shimada N, Urayama M, Niwa Y, Takeuchi M. [McGRATH MAC Videolaryngoscope: clinical assessment of its performance in 50 surgical patients]. Masui. 2014 Sep;63(9):1025-8. Japanese.
PubMed 25255665Biro P. The SensaScope- A new hybrid video intubation stylet. Saudi J Anaesth. 2011 Oct;5(4):411-3. doi: 10.4103/1658-354X.87271.
PubMed 22144929Biro P, Battig U, Henderson J, Seifert B. First clinical experience of tracheal intubation with the SensaScope, a novel steerable semirigid video stylet. Br J Anaesth. 2006 Aug;97(2):255-61. doi: 10.1093/bja/ael135. Epub 2006 Jun 1.
PubMed 16740606
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between SensaScope Intuboscope and McGrath Series 5 Videolaryngoscope to Tracheal Intubation: a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT02348736
- Acronym / sponsor ID
- SensaScope / JohannesGUM
- Conditions
- Airway Morbidity
- Keywords
- airway, videolaryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Jan 2015 (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.
A randomized controlled prospective study of laryngoscopy and intubation time comparing SensaScope and the McGrath® Series 5 video laryngoscope.
Detailed description
The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to semi-rigid stylet. An national, mono center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® Series 5 versus SensaScope in adult patients under general anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SensaScope | Experimental | Device: Time for tracheal intubationTime for tracheal intubation with the SensaScope |
| McGrath Series 5 | Experimental | Device: Time for tracheal intubationTime for tracheal intubation with the McGrath Series 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 Years No concurrent participation in another study
- capacity to consent
- Present written informed consent of the research participant
- Elective surgery under general anesthesia
Key exclusion criteria (9 listed)
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
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 |
|---|---|---|
| Time for tracheal intubationIn a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve | Device | McGrath Series 5, SensaScope |
Primary outcome
comparison of different time for tracheal intubation
Time frame: <2min
times for tracheal intubation, View of the glottic, experience in anesthesia
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 19 Jan 2018.
- Background: PubMed 25255665Negishi Y, Shimada N, Urayama M, Niwa Y, Takeuchi M. [McGRATH MAC Videolaryngoscope: clinical assessment of its performance in 50 surgical patients]. Masui. 2014 Sep;63(9):1025-8. Japanese.
- Results publication: PubMed 22144929Biro P. The SensaScope- A new hybrid video intubation stylet. Saudi J Anaesth. 2011 Oct;5(4):411-3. doi: 10.4103/1658-354X.87271.
- Results publication: PubMed 16740606Biro P, Battig U, Henderson J, Seifert B. First clinical experience of tracheal intubation with the SensaScope, a novel steerable semirigid video stylet. Br J Anaesth. 2006 Aug;97(2):255-61. doi: 10.1093/bja/ael135. Epub 2006 Jun 1.
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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.
Marc Kriege, MD principal investigator
University JG, Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time for tracheal intubation in people with Airway Morbidity, run by Johannes Gutenberg University Mainz 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 4 inclusion and 9 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 19 Jan 2018. 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?
comparison of different time for tracheal intubation (time frame: <2min). 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 NCT02348736, which also lists 3 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 19 Jan 2018.