Intubation ComplicationNCT03115606
Comparison of C-Mac D Blade and Fastrach Laryngeal Mask Airway on Cervical Spine Motion Conditions
A study testing C-Mac D Blade and Fastrach LMA in people with Intubation Complication and Cervical Discopathy, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In patients with cervical spine disorders or hernia, in-line stabilization and immobilization during tracheal intubation is used to avoid neck injury. With direct laryngoscopy cranio-cervical motion can result injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intubation Complication, Cervical Discopathy
- What is being tested?
- C-Mac D Blade and Fastrach LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Mar 2017to 13 Apr 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of cervical disc herniation ( scheduled cervical discectomy)
- American Society of Anesthesiology (ASA) physical status I-III patients
Who cannot join
- ASA IV patients
- Age under 18 years, over 70 years
- Hepatic disease
- Renal disease
- Cardiac disease
- Pregnancy
- Anticipated difficult airway
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey Ankara, Turkey
Ankara, 06810
About this study
Official title: Comparison of C-Mac D Blade and Fastrach Laryngeal Mask Airway on Cervical Spine Motion Conditions in Cervical Discectomy
In patients with cervical spine disorders or hernia, in-line stabilization and immobilization during tracheal intubation is used to avoid neck injury. With direct laryngoscopy cranio-cervical motion can result injury. The aim of the study is to compare two different device (C-Mac D blade versus fastrach LMA ) regarding cervical motions during intubation.
Read the detailed description
In simulated or clinical settings of restricted neck mobility, videolaryngoscopes and fastrach LMA have performed well but neck motion can be occured. Endotracheal intubation will be performed under fluoroscopy. In this study the neck motion angles will be investigated during intubation . The angles will be assessed on fluoroscopy images. A Angle: Angle of the line between occipital protuberance and anterior process of the foramen magnum with the line between central point of spinous process C1 vertebrae and the anterior process of foramen magnum. The reference line for the occiput is defined as a line between the base of the sella and the opisthion (lineA), and the C1 reference line as a line between the lower cortical margin of the spinous process (line B). The C2 reference line is defined as a line between the anterior , inferior margin of the C2 body and the lower cortical margin of the C2 spinous process (lineC). The C5 reference line is a tangent along the superior endplate of the C5 vertebral body (line D). The groups will be compared statistically.
- Conditions
- Intubation Complication, Cervical Discopathy
- Being tested
- C-Mac D Blade, Fastrach LMA
- Keywords
- videolaryngoscope, Fastrach LMA, cervical motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Mac D BladeDevice
Videolaryngoscope
Fastrach LMADevice
Laryngeal mask airway
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope | Active comparator | Patients intubated with C-Mac D Blade Videolaryngoscope Receives: Device: C-Mac D Blade |
| Fastrach LMA | Active comparator | Patients intubated with Fastrach LMA Receives: Device: Fastrach LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle A (degree), Angle B (degree), Angle C(degree)
Angle of the line between occipital protuberance and central point of spinous process of C1 vertebrae. Angle B and Angle C (degree)
Measured: 30 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start24 Mar 2017
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
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 Intubation ComplicationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
- Investigators
- derya özkan, assoc prof, Principal investigator, Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Anesthesiology and Reanimation Clinic Ankara, Turkey Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115606
- Sponsor's protocol ID
- Diskapi3
- Status last verified
- May 2018
- First submitted
- 26 Mar 2017
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozkan D, Altinsoy S, Sayin M, Dolgun H, Ergil J, Donmez A. Comparison of cervical spine motion during intubation with a C-MAC D-Blade(R) and an LMA Fastrach(R). Anaesthesist. 2019 Feb;68(2):90-96. doi: 10.1007/s00101-018-0533-3. Epub 2019 Jan 9.
PubMed 30627738
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of C-Mac D Blade and Fastrach Laryngeal Mask Airway on Cervical Spine Motion Conditions in Cervical Discectomy
- ClinicalTrials.gov ID
- NCT03115606
- Acronym / sponsor ID
- Diskapi3
- Conditions
- Intubation Complication, Cervical Discopathy
- Keywords
- videolaryngoscope, Fastrach LMA, cervical motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 14 Apr 2017 (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.
In patients with cervical spine disorders or hernia, in-line stabilization and immobilization during tracheal intubation is used to avoid neck injury. With direct laryngoscopy cranio-cervical motion can result injury. The aim of the study is to compare two different device (C-Mac D blade versus fastrach LMA ) regarding cervical motions during intubation.
Detailed description
In simulated or clinical settings of restricted neck mobility, videolaryngoscopes and fastrach LMA have performed well but neck motion can be occured. Endotracheal intubation will be performed under fluoroscopy. In this study the neck motion angles will be investigated during intubation . The angles will be assessed on fluoroscopy images. A Angle: Angle of the line between occipital protuberance and anterior process of the foramen magnum with the line between central point of spinous process C1 vertebrae and the anterior process of foramen magnum. The reference line for the occiput is defined as a line between the base of the sella and the opisthion (lineA), and the C1 reference line as a line between the lower cortical margin of the spinous process (line B). The C2 reference line is defined as a line between the anterior , inferior margin of the C2 body and the lower cortical margin of the C2 spinous process (lineC). The C5 reference line is a tangent along the superior endplate of the C5 vertebral body (line D). The groups will be compared statistically.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope | Active comparator | Device: C-Mac D BladePatients intubated with C-Mac D Blade Videolaryngoscope |
| Fastrach LMA | Active comparator | Device: Fastrach LMAPatients intubated with Fastrach LMA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of cervical disc herniation ( scheduled cervical discectomy)
- American Society of Anesthesiology (ASA) physical status I-III patients
Key exclusion criteria (7 listed)
- ASA IV patients
- Age under 18 years, over 70 years
- Hepatic disease
- Renal disease
- Cardiac disease
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 |
|---|---|---|
| C-Mac D BladeVideolaryngoscope | Device | Videolaryngoscope |
| Fastrach LMALaryngeal mask airway | Device | Fastrach LMA |
Primary outcome
Angle A (degree), Angle B (degree), Angle C(degree)
Time frame: 30 second
Angle of the line between occipital protuberance and central point of spinous process of C1 vertebrae. Angle B and Angle C (degree)
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 15 May 2018.
- Derived from this study: PubMed 30627738Ozkan D, Altinsoy S, Sayin M, Dolgun H, Ergil J, Donmez A. Comparison of cervical spine motion during intubation with a C-MAC D-Blade(R) and an LMA Fastrach(R). Anaesthesist. 2019 Feb;68(2):90-96. doi: 10.1007/s00101-018-0533-3. Epub 2019 Jan 9.
- Individual participant dataSharing planned: Undecided
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The ED-AWARENESS-2 Trial
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
derya özkan, assoc prof principal investigator
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Anesthesiology and Reanimation Clinic Ankara, Turkey Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Mac D Blade and Fastrach LMA in people with Intubation Complication and Cervical Discopathy, run by Diskapi Teaching and Research Hospital 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 2 inclusion and 7 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 15 May 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 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?
Angle A (degree), Angle B (degree), Angle C(degree) (time frame: 30 second). 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 NCT03115606, 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 15 May 2018.