Failed or Difficult IntubationNCT01794611
Different Types Of Laryngoscopes During Routine Intubation in Adult Patients
A study testing laryngoscopy in people with Failed or Difficult Intubation, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
C-MAC videolaryngoscope (Karl Storz, Tuttlingen, GERMANY) with its Macintosh like blade is used with standard direct laryngoscopy technique. KingsVisionTM videolaryngoscopes (KingSystems, IN, USA) have also Macintosh like single use blades that are channeled, wider and shorter than conventional Macintosh blades.We aim… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Failed or Difficult Intubation
- What is being tested?
- laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Mar 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 200 American Society of Anesthesiology I-III patients between 18-80 years old undergoing elective abdominal surgery and planned to be intubated orotracheally will be included in the study.
Who cannot join
- Patients with upper respiratory problems and predicted difficult airways will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Fatih, 34400
About this study
Official title: Comparison Of C-MAC Videolaryngoscopy, Kingsvision Videolaryngoscopy and Macintosh Laryngoscopy During Routine Intubation in Adult Patients
C-MAC videolaryngoscope (Karl Storz, Tuttlingen, GERMANY) with its Macintosh like blade is used with standard direct laryngoscopy technique. KingsVisionTM videolaryngoscopes (KingSystems, IN, USA) have also Macintosh like single use blades that are channeled, wider and shorter than conventional Macintosh blades.We aim to compare these two laryngoscopes and Macintosh laryngoscope during routine intubation in adult patients.
- Conditions
- Failed or Difficult Intubation
- Being tested
- laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngoscopyDevice
Also called C-MAC videolaryngoscopy (Karl Storz, Tuttlingen, GERMANY), KingsVision videolaryngoscopy (KingSystems, IN, USA), Macintosh Laryngscope (Welch Allyn,USA)
| Study group | Role | What they receive |
|---|---|---|
| Laryngoscopy | Experimental | Patients will be intubated by an experienced anesthesiologists. Anesthesiologist first uses Macintosh laryngoscope then KingsVision videolaryngoscope and lastly C-MAC videolaryngoscope to intubate patients. Cormack-Lehane scores, the time from the start of laryngoscopy to visualization of the vocal cords and the time from the visualization of the vocals from the successful intubation will be recorded. The success of the intubation will be assessed with bilateral chest auscultation. If visualization of the vocal cords or placing of the endotracheal tube was not successful after 60 seconds with a particular laryngoscope, it will be left out and patient will be ventilated for 1 minutes and then pass to other laryngoscopes. Receives: Device: laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack-Lehane Score
Patients will be preoxygenated with 100% oxygen for 3 minutes before the anesthesia induction. After induction when the train of four ratio reaches %0, patients will be intubated by one of three anesthesiologists with at least 10 years of experience. The anesthesiologist first will use the Macintosh laryngoscope then KingsVisionTM videolaryngoscope and lastly C-MAC videolaryngoscope to intubate the patients. The Cormack-Lehane scores observed during each laryngoscopy will be recorded
Measured: 5 minutes
Secondary outcomes (1)
time
Patients will be preoxygenated with 100% oxygen for 3 minutes before the anesthesia induction. After induction when the train of four ratio reaches %0, patients will be intubated by one of three anesthesiologists with at least 10 years of experience. The anesthesiologist first will use the Macintosh laryngoscope then KingsVisionTM videolaryngoscope and lastly C-MAC videolaryngoscope to intubate the patients. The time from the start of laryngoscopy to the visualization of the vocal cords and the time from the visualization of the vocals from the successful intubation observed during each laryngoscopy will be recorded.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionMar 2013
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 Failed or Difficult IntubationStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
- Investigators
- Guniz Koksal, Ass.Prof., Study director, Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794611
- Sponsor's protocol ID
- 36049
- Status last verified
- Feb 2013
- First submitted
- 15 Feb 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xue FS, Liao X, Cheng Y. Comparative performance of C-MAC video laryngoscope and macintosh direct laryngoscope for emergency intubation. Ann Emerg Med. 2012 Dec;60(6):817-8; author reply 818-9. doi: 10.1016/j.annemergmed.2012.05.044. No abstract available.
PubMed 23178024
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of C-MAC Videolaryngoscopy, Kingsvision Videolaryngoscopy and Macintosh Laryngoscopy During Routine Intubation in Adult Patients
- ClinicalTrials.gov ID
- NCT01794611
- Acronym / sponsor ID
- 36049
- Conditions
- Failed or Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Feb 2013 (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.
C-MAC videolaryngoscope (Karl Storz, Tuttlingen, GERMANY) with its Macintosh like blade is used with standard direct laryngoscopy technique. KingsVisionTM videolaryngoscopes (KingSystems, IN, USA) have also Macintosh like single use blades that are channeled, wider and shorter than conventional Macintosh blades.We aim to compare these two laryngoscopes and Macintosh laryngoscope during routine intubation in adult patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laryngoscopy | Experimental | Device: laryngoscopyPatients will be intubated by an experienced anesthesiologists. Anesthesiologist first uses Macintosh laryngoscope then KingsVision videolaryngoscope and lastly C-MAC videolaryngoscope to intubate patients. Cormack-Lehane scores, the time from the start of laryngoscopy to visualization of the vocal cords and the time from the visualization of the vocals from the successful intubation will be recorded. The success of the intubation will be assessed with bilateral chest auscultation. If visualization of the vocal cords or placing of the endotracheal tube was not successful after 60 seconds with a particular laryngoscope, it will be left out and patient will be ventilated for 1 minutes and then pass to other laryngoscopes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 200 American Society of Anesthesiology I-III patients between 18-80 years old undergoing elective abdominal surgery and planned to be intubated orotracheally will be included in the study.
Key exclusion criteria (1 listed)
- Patients with upper respiratory problems and predicted difficult airways will be excluded from the study.
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 |
|---|---|---|
| laryngoscopyAlso: C-MAC videolaryngoscopy (Karl Storz, Tuttlingen, GERMANY), KingsVision videolaryngoscopy (KingSystems, IN, USA), Macintosh Laryngscope (Welch Allyn,USA) | Device | Laryngoscopy |
Primary outcome
Cormack-Lehane Score
Time frame: 5 minutes
Patients will be preoxygenated with 100% oxygen for 3 minutes before the anesthesia induction. After induction when the train of four ratio reaches %0, patients will be intubated by one of three anesthesiologists with at least 10 years of experience. The anesthesiologist first will use the Macintosh laryngoscope then KingsVisionTM videolaryngoscope and lastly C-MAC videolaryngoscope to intubate the patients. The Cormack-Lehane scores observed during each laryngoscopy will be recorded
1 secondary outcome
time
Time frame: 5 minutes
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 4 Apr 2013.
- Background: PubMed 23178024Xue FS, Liao X, Cheng Y. Comparative performance of C-MAC video laryngoscope and macintosh direct laryngoscope for emergency intubation. Ann Emerg Med. 2012 Dec;60(6):817-8; author reply 818-9. doi: 10.1016/j.annemergmed.2012.05.044. No abstract available.
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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.
Guniz Koksal, Ass.Prof. study director
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laryngoscopy in people with Failed or Difficult Intubation, run by Istanbul 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 1 inclusion and 1 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 4 Apr 2013. 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?
Cormack-Lehane Score (time frame: 5 minutes). 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 NCT01794611, 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 4 Apr 2013.