Infant ConditionsNCT04153370
Comparison of Different Video Laryngoscopes in Infants Undergoing Neurosurgery: a Prospective Randomized Clinical Trial
A study testing Airtraq, glidescope and c-mac in people with Infant Conditions, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy. We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of <1 year old children undergoing neurosurgery. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Infant Conditions
- What is being tested?
- Airtraq, glidescope and c-mac
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2019to 5 Feb 2020
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 0-1 age
- undergoing neurosurgery
- ASA 1-2
Who cannot join
- cardiac problems
- ASA 3-4
- emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Airtraq, Glidescope and C-mac in Infants
difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.
We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of <1 year old children undergoing neurosurgery.
Read the detailed description
Aim: difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.
Methods: We enroll 20 patients age under 1 year old undergoing neurosurgery in this prospective randomized study. We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of <1 year old children undergoing neurosurgery regarding intubation times and intubation success rates.
- Conditions
- Infant Conditions
- Being tested
- Airtraq, glidescope, c-mac
- Keywords
- airtraq, glidescope, c-mac, videolaryngoscope, intubation, infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirtraqDevice
Also called videolaryngoscope
airtraq video laryngoscope was used for intubation of the infant
glidescopeDevice
Also called videolaryngoscope
glidescope video laryngoscope was used for intubation of the infant
c-macDevice
Also called videolaryngoscope
c-mac video laryngoscope was used for intubation of the infant
| Study group | Role | What they receive |
|---|---|---|
| intubation time airtraq | Active comparator | inserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords Receives: Device: Airtraq |
| intubation time glidescope | Active comparator | inserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords Receives: Device: glidescope |
| intubation time c-mac | Active comparator | inserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords Receives: Device: c-mac |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
device entering the oral cavity till visualization of the tube entering through the vocal cords
Measured: 40 seconds
Secondary outcomes (1)
insertion time
device entering the oral cavity till the optimal visualization
Measured: 20 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start5 Nov 2019
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ConditionsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153370
- Sponsor's protocol ID
- KOU KAEK 2015/311
- Status last verified
- Feb 2020
- First submitted
- 4 Nov 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Airtraq, Glidescope and C-mac in Infants
- ClinicalTrials.gov ID
- NCT04153370
- Acronym / sponsor ID
- KOU KAEK 2015/311
- Conditions
- Infant Conditions
- Keywords
- airtraq, glidescope, c-mac, videolaryngoscope, intubation, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 6 Nov 2019 (actual)
- 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.
difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.
We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of <1 year old children undergoing neurosurgery.
Detailed description
Aim: difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.
Methods: We enroll 20 patients age under 1 year old undergoing neurosurgery in this prospective randomized study. We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of <1 year old children undergoing neurosurgery regarding intubation times and intubation success rates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intubation time airtraq | Active comparator | Device: Airtraqinserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords |
| intubation time glidescope | Active comparator | Device: glidescopeinserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords |
| intubation time c-mac | Active comparator | Device: c-macinserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 0-1 age
- undergoing neurosurgery
- ASA 1-2
Key exclusion criteria (3 listed)
- cardiac problems
- ASA 3-4
- emergency
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 |
|---|---|---|
| AirtraqAlso: videolaryngoscopeairtraq video laryngoscope was used for intubation of the infant | Device | intubation time airtraq |
| glidescopeAlso: videolaryngoscopeglidescope video laryngoscope was used for intubation of the infant | Device | intubation time glidescope |
| c-macAlso: videolaryngoscopec-mac video laryngoscope was used for intubation of the infant | Device | intubation time c-mac |
Primary outcome
intubation time
Time frame: 40 seconds
device entering the oral cavity till visualization of the tube entering through the vocal cords
1 secondary outcome
insertion time
Time frame: 20 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 20 Feb 2020.
- Individual participant dataSharing planned: No
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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 Airtraq, glidescope and c-mac in people with Infant Conditions, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 20 Feb 2020. 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 Turkey (Türkiye). 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?
intubation time (time frame: 40 seconds). 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 20 Feb 2020.