Airway ManagementNCT02897518
Videolaryngoscopes for Tracheal Intubation
A study testing Imago V-Balde and Glidescope in people with Airway Management, run by Federico II University at 1 site in Italy.
Trial summary
The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal… Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Airway Management
- What is being tested?
- Imago V-Balde and Glidescope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Jan 2016
- 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 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Mallampati class 3-4
- inter-incisor distance < 30 mm
- mental-thyroidal distance < 60 mm
- large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust -reduced head and neck motility
- reduced mental-jugular distance.
Who cannot join
- < 1 criteria for predicted difficult airway
- emergency surgery
- age < 18 years
- declined consent to participate
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Naples Federico II department of Anesthesia and Critical Care
Naples, Italy, 80100
About this study
Official title: Comparison Between Imago V-Blade and Glidescope During Endotracheal Intubation: a Feasibility Study
The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and Glidescope®.
Patients admit to the operation rooms of University of Naples "Federico II" and requiring endotracheal intubation for general anesthesia will be consecutively screened for the presence of predicted difficult airway according Italian guideline. According to this guideline, the presence of one or more of the following parameters may be considered highly predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance < 30 mm, mental-thyroidal distance < 60 mm, large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced mental-jugular distance. Patients matching more then 1 of the previous criteria stated by Italian guideline will be included in this case controlled study. Patients 1) without criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged < 18 years; or 4) declined consent to participate, will be excluded from this study.The primary end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary end-points were the learning curve, the intubation time, the Cormack and Lehane score view, and the need for maneuvers to aid the endotracheal intubation comparing different videolaryngoscopes available in our department. Two anesthesiologists with 10 years of experience in conventional endotracheal intubation and trained for video assisted intubation will perform the maneuvers.
- Conditions
- Airway Management
- Being tested
- Imago V-Balde, Glidescope
- Keywords
- Videolaryngoscopes, Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imago V-BaldeDevice
the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual
GlidescopeDevice
the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual
| Study group | Role | What they receive |
|---|---|---|
| endotracheal intubation with Imago V-blade | Experimental | Patients in this arm will receive endotracheal intubation with the Imago V-Blade videolaryngoscopes. Receives: Device: Imago V-Balde |
| endotracheal intubation with Glidescope | Active comparator | Patients in this arm will receive endotracheal intubation with the glidescope videolaryngoscopes. Receives: Device: Glidescope |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of endotracheal intubation
Measured: within 60 seconds
Secondary outcomes (5)
Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope
Time to reach a successful endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide
Measured: wthin 120 seconds
Intubation time
time to reach endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide
Measured: wthin 120 seconds
Cormack and Lehane score view
Measured: During endotracheal intubation
use of adjunctive maneuvers to aid the endotracheal intubation
the investigators evaluated the necessary maneuvers to aid a successful endotracheal intubation as number of Readjusting patient's head, number of external laryngeal pressure, number of advancement or withdrawal the blade and number of increased lifting force
Measured: During endotracheal intubation
Intubation difficulty scale score
Time to pass the vocal cord during the successful endotracheal intubation measured from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide
Measured: within 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
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 Federico II UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Vargas, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897518
- Sponsor's protocol ID
- Airway1
- Status last verified
- Jan 2017
- First submitted
- 25 Aug 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Vargas M, Pastore A, Aloj F, Laffey JG, Servillo G. A comparison of videolaryngoscopes for tracheal intubation in predicted difficult airway: a feasibility study. BMC Anesthesiol. 2017 Feb 20;17(1):25. doi: 10.1186/s12871-017-0318-2.
PubMed 28219331
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Imago V-Blade and Glidescope During Endotracheal Intubation: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02897518
- Acronym / sponsor ID
- Airway1
- Conditions
- Airway Management
- Keywords
- Videolaryngoscopes, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Sep 2016 (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.
The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and Glidescope®.
Patients admit to the operation rooms of University of Naples "Federico II" and requiring endotracheal intubation for general anesthesia will be consecutively screened for the presence of predicted difficult airway according Italian guideline. According to this guideline, the presence of one or more of the following parameters may be considered highly predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance < 30 mm, mental-thyroidal distance < 60 mm, large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced mental-jugular distance. Patients matching more then 1 of the previous criteria stated by Italian guideline will be included in this case controlled study. Patients 1) without criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged < 18 years; or 4) declined consent to participate, will be excluded from this study.The primary end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary end-points were the learning curve, the intubation time, the Cormack and Lehane score view, and the need for maneuvers to aid the endotracheal intubation comparing different videolaryngoscopes available in our department. Two anesthesiologists with 10 years of experience in conventional endotracheal intubation and trained for video assisted intubation will perform the maneuvers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endotracheal intubation with Imago V-blade | Experimental | Device: Imago V-BaldePatients in this arm will receive endotracheal intubation with the Imago V-Blade videolaryngoscopes. |
| endotracheal intubation with Glidescope | Active comparator | Device: GlidescopePatients in this arm will receive endotracheal intubation with the glidescope videolaryngoscopes. |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>18 years
- Mallampati class 3-4
- inter-incisor distance < 30 mm
- mental-thyroidal distance < 60 mm
- large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust -reduced head and neck motility
Key exclusion criteria (4 listed)
- < 1 criteria for predicted difficult airway
- emergency surgery
- age < 18 years
- declined consent 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 |
|---|---|---|
| Imago V-Baldethe endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual | Device | endotracheal intubation with Imago V-blade |
| Glidescopethe endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual | Device | endotracheal intubation with Glidescope |
Primary outcome
feasibility of endotracheal intubation
Time frame: within 60 seconds
5 secondary outcomes
Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope
Time frame: wthin 120 seconds
Intubation time
Time frame: wthin 120 seconds
Cormack and Lehane score view
Time frame: During endotracheal intubation
use of adjunctive maneuvers to aid the endotracheal intubation
Time frame: During endotracheal intubation
Intubation difficulty scale score
Time frame: within 60 seconds
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 5 Jan 2017.
- Derived from this study: PubMed 28219331Vargas M, Pastore A, Aloj F, Laffey JG, Servillo G. A comparison of videolaryngoscopes for tracheal intubation in predicted difficult airway: a feasibility study. BMC Anesthesiol. 2017 Feb 20;17(1):25. doi: 10.1186/s12871-017-0318-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imago V-Balde and Glidescope in people with Airway Management, run by Federico II University at 1 site in Italy.
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 6 inclusion and 4 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 5 Jan 2017. 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 Italy. 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?
feasibility of endotracheal intubation (time frame: within 60 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 NCT02897518, 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 5 Jan 2017.