Intubation;DifficultNCT03719638
Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children
A study testing D-blade of videolaryngoscope, simulated difficult airway and Macintosh videolaryngoscope in people with Intubation;Difficult, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Airway management and tracheal intubation are routinely performed in paediatric anaesthesia and yet are associated with preventable adverse events. The D-blade of videolaryngoscope is preferred in difficult intubation with a more curved blade then the Macintosh videolaryngoscope blade, which may be more useful in… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- D-blade of videolaryngoscope, simulated difficult airway and Macintosh videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2018to 15 Mar 2019
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II patients
- Undergoing elective surgeries
- Age between 1-5 years
Who cannot join
- Anticipated difficult intubation
- Pulmonery diseases
- >III ASA scores
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children, a Randomized Controlled Trial
Airway management and tracheal intubation are routinely performed in paediatric anaesthesia and yet are associated with preventable adverse events. The D-blade of videolaryngoscope is preferred in difficult intubation with a more curved blade then the Macintosh videolaryngoscope blade, which may be more useful in difficult intubation. The aim of the study is to compare the D-blade of videolaryngoscope with Macintosh videolaryngoscope blade.
- Conditions
- Intubation;Difficult
- Being tested
- D-blade of videolaryngoscope, simulated difficult airway, Macintosh videolaryngoscope
- Keywords
- D-Blade, Macintosh videolaryngoscope blade, Simulated difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-blade of videolaryngoscopeDevice
intubation will be done using d-blade of videolaryngoscope
simulated difficult airwayOther
extension of head will be limited by using collar.
Macintosh videolaryngoscopeDevice
intubation will be done using macintosh videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| D-blade group | Active comparator | Intubation will be done using D-blade of videolaryngoscope in a simulated difficult airway Difficult airway will be simulated with collar. Receives: Device: D-blade of videolaryngoscope; Other: simulated difficult airway |
| Macintosh group | Active comparator | Intubation will be done using Macintosh videolaryngoscope in a simulated difficult airway Difficult airway will be simulated with collar. Receives: Other: simulated difficult airway; Device: Macintosh videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
Time of endotracheal intubation will be recorded.
Measured: time between handling videolaryngoscope and inserting endotracheal tube
Secondary outcomes (1)
Cormack and Lehane score
Cormack and Lehane scores from 1 to 4 where 1 is the best and 4 is the worst score for laryngoscopy view will be recorded for each patient
Measured: During the intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start15 Nov 2018
- Primary completion15 Feb 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alparslan Kus, Kocaeli University
- Investigators
- Alparslan Kus, MD, Principal investigator, Kocaeli University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719638
- Sponsor's protocol ID
- 2018-154
- Status last verified
- Nov 2020
- First submitted
- 20 Oct 2018
- Last updated
- 10 Nov 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 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03719638
- Acronym / sponsor ID
- 2018-154
- Conditions
- Intubation;Difficult
- Keywords
- D-Blade, Macintosh videolaryngoscope blade, Simulated difficult intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 25 Oct 2018 (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.
Airway management and tracheal intubation are routinely performed in paediatric anaesthesia and yet are associated with preventable adverse events. The D-blade of videolaryngoscope is preferred in difficult intubation with a more curved blade then the Macintosh videolaryngoscope blade, which may be more useful in difficult intubation. The aim of the study is to compare the D-blade of videolaryngoscope with Macintosh videolaryngoscope blade.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-blade group | Active comparator | Device: D-blade of videolaryngoscope, Other: simulated difficult airwayIntubation will be done using D-blade of videolaryngoscope in a simulated difficult airway Difficult airway will be simulated with collar. |
| Macintosh group | Active comparator | Other: simulated difficult airway, Device: Macintosh videolaryngoscopeIntubation will be done using Macintosh videolaryngoscope in a simulated difficult airway Difficult airway will be simulated with collar. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I-II patients
- Undergoing elective surgeries
- Age between 1-5 years
Key exclusion criteria (3 listed)
- Anticipated difficult intubation
- Pulmonery diseases
- >III ASA scores
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 |
|---|---|---|
| D-blade of videolaryngoscopeintubation will be done using d-blade of videolaryngoscope | Device | D-blade group |
| simulated difficult airwayextension of head will be limited by using collar. | Other | D-blade group, Macintosh group |
| Macintosh videolaryngoscopeintubation will be done using macintosh videolaryngoscope | Device | Macintosh group |
Primary outcome
intubation time
Time frame: time between handling videolaryngoscope and inserting endotracheal tube
Time of endotracheal intubation will be recorded.
1 secondary outcome
Cormack and Lehane score
Time frame: During the 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 10 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Intubation;Difficult
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.
Alparslan Kus, MD principal investigator
Kocaeli University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-blade of videolaryngoscope, simulated difficult airway and Macintosh videolaryngoscope in people with Intubation;Difficult, 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 10 Nov 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: time between handling videolaryngoscope and inserting endotracheal tube). 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 10 Nov 2020.