Elective IntubationPhase 2/3NCT02095470
Video Laryngoscope, New Intubation Device
A Phase 2/3 study testing video laryngoscope and traditional laryngoscope in people with Elective Intubation, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
new glidoscope was tested on 401 patients Read more about this study
- Who is it for?
- Ages 19 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Elective Intubation
- What is being tested?
- video laryngoscope and traditional laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 401 participants
- Where
- 1 siteIran
- Study dates
- Feb 2013to Feb 2014
- Phase
- Phase 2/3
- 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 19 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective operation who filled the consent
Who cannot join
- poor intubation
- emergency cases
- hemodynamic derangement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Video Laryngoscope, a New Practical Intubation Device: Randomized Clinical Trial in 401 Patients
new glidoscope was tested on 401 patients
Read the detailed description
Four hundred and one patients who were scheduled for elective operation, were randomly assigned to be intubated by direct laryngoscopy using a Macintosh blade size 3rd (DL, n=196) or intubation using the video laryngoscope (VL, n=205). Prior to intubation all patients were given a similar regimen of induction of anesthesia. The patients were then intubated, using direct laryngoscopy or the VL, by a different anesthetist during which the larynx was inspected and given a laryngoscopy score. Time to intubate, failure rate, injuries, personnel pleasure and, aspiration rate were measured
- Conditions
- Elective Intubation
- Being tested
- video laryngoscope, traditional laryngoscope
- Keywords
- Laryngoscopy, Equipment, Video Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video laryngoscopeDevice
Also called glidescope
newly developed innovatory device
traditional laryngoscopeDevice
traditional way for intubation
| Study group | Role | What they receive |
|---|---|---|
| videolaryngoscope group | Experimental | video laryngoscopy was done for them Receives: Device: video laryngoscope |
| traditional laryngoscope | Placebo comparator | comparison to active group with routine laryngoscope Receives: Device: traditional laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
laryngoscopy grade
grade of laryngoscopy
Measured: hospital stay (average 48 hours)
time to intubation
time to successful intubation in minutes
Measured: 60 minutes
unsuccessful attempts
number of failure
Measured: 60 minutes
Secondary outcomes (1)
aspiration
clinical aspiration or radiological
Measured: hospital stay ( 48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective IntubationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Education Development Center, Inc.
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095470
- Sponsor's protocol ID
- 93-4678
- Other IDs
- 93-4687
- Status last verified
- Mar 2014
- First submitted
- 15 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Video Laryngoscope, a New Practical Intubation Device: Randomized Clinical Trial in 401 Patients
- ClinicalTrials.gov ID
- NCT02095470
- Acronym / sponsor ID
- 93-4678
- Conditions
- Elective Intubation
- Keywords
- Laryngoscopy, Equipment, Video Laryngoscope
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Education Development Center, Inc.
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 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.
new glidoscope was tested on 401 patients
Detailed description
Four hundred and one patients who were scheduled for elective operation, were randomly assigned to be intubated by direct laryngoscopy using a Macintosh blade size 3rd (DL, n=196) or intubation using the video laryngoscope (VL, n=205). Prior to intubation all patients were given a similar regimen of induction of anesthesia. The patients were then intubated, using direct laryngoscopy or the VL, by a different anesthetist during which the larynx was inspected and given a laryngoscopy score. Time to intubate, failure rate, injuries, personnel pleasure and, aspiration rate were measured
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| videolaryngoscope group | Experimental | Device: video laryngoscopevideo laryngoscopy was done for them |
| traditional laryngoscope | Placebo comparator | Device: traditional laryngoscopecomparison to active group with routine laryngoscope |
Who may qualify
- Ages
- 19 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective operation who filled the consent
Key exclusion criteria (3 listed)
- poor intubation
- emergency cases
- hemodynamic derangement
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 |
|---|---|---|
| video laryngoscopeAlso: glidescopenewly developed innovatory device | Device | videolaryngoscope group |
| traditional laryngoscopetraditional way for intubation | Device | traditional laryngoscope |
Primary outcome
laryngoscopy grade
Time frame: hospital stay (average 48 hours)
grade of laryngoscopy
time to intubation
Time frame: 60 minutes
time to successful intubation in minutes
unsuccessful attempts
Time frame: 60 minutes
number of failure
1 secondary outcome
aspiration
Time frame: hospital stay ( 48 hours)
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 24 Mar 2014.
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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 Phase 2/3 study testing video laryngoscope and traditional laryngoscope in people with Elective Intubation, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 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 24 Mar 2014. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
laryngoscopy grade (time frame: hospital stay (average 48 hours)). The study lists 3 primary outcomes in all. 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 24 Mar 2014.