Intubation; Difficult or FailedNCT06213389
Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy
A study testing EzVision® videolaryngoscopy and Macintosh Blade in people with Intubation; Difficult or Failed and Airway Complication of Anesthesia, run by Nevsehir Public Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the EzVision® videoryngoscope with conventional laryngoscopy using a Macintosh blade in patients with suspected difficult intubation. This study primarily aims to test the hypothesis that laryngoscopy image is better with EzVision® videoryngoscopy compared to direct laryngoscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Airway Complication of Anesthesia
- What is being tested?
- EzVision® videolaryngoscopy and Macintosh Blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 19 Nov 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years old;
- American Association of Anesthesiologists (ASA) physical condition I-II-III;
- Elective surgery requiring oral endotracheal intubation for general anesthesia;
- Compliance with one of the difficult intubation estimation criteria (if more than one)
- Expected extubation in the operating room
Who cannot join
- Refusal to participate in research;
- Age <18 and >65
- ASA IV and above
- Emergency cases
- Body Mass Index (BMI) > 40 kg/m2.
- Pregnancy
- Cardiac surgery
- Unexpectedly difficult intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy in Patients Considering Difficult Intubation
The aim of this study is to compare the EzVision® videoryngoscope with conventional laryngoscopy using a Macintosh blade in patients with suspected difficult intubation. This study primarily aims to test the hypothesis that laryngoscopy image is better with EzVision® videoryngoscopy compared to direct laryngoscopy. The secondary hypothesis is also to test the view that, compared to direct laryngoscopy, EzVision® videolingoscopy will improve intubation success, reduce intubation attempts, shorten intubation time, facilitate intubation, and cause less additional complications such as bleeding or sore throat.
- Being tested
- EzVision® videolaryngoscopy, Macintosh Blade
- Keywords
- Intubation, Difficult, Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzVision® videolaryngoscopyDevice
Patient will be intubated with EzVision® videolaryngoscopy
Macintosh BladeDevice
Patient will be intubated with Macintosh Blade
| Study group | Role | What they receive |
|---|---|---|
| Patients to entubate with EzVision® videolaryngoscopy | Experimental | Patients will intubate with EzVision® videolaryngoscopy Receives: Device: EzVision® videolaryngoscopy |
| Patients to intubate with Macintosh blade | Other | Patients will intubate with Macintosh blade Receives: Device: Macintosh Blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glottis viewing
Glottical viewing will be measured by Modified Cormack Lehane grading. In this scoring system, number 1 indicates the best appearance, while number 4 indicates the worst situation where the glottis is not visible. This measurement have no specific value, but it evaluates glottis opening as visually.
- Fill view of the glottis 2a. Partial view of the glottis 2b. Arytenoids or posterior part of the vocal cords only visible 3. Only epiglottis visible 4. Neither glottis nor epiglottis visible
Measured: Approximately 1 year
Secondary outcomes (4)
Intubation failure
Intubation failure: It is defined as intubation failure if one of the following occurs:
- Failure to intubate despite three intubation attempts,
- Situation that requires replacement of the intubation device,
- Difficulty with intubation that will stop working at the discretion of the anesthesiologist
Measured: Approximately 1 year
Attempted intubation
Attempted intubation: defined as inserting the endotracheal tube into the oral cavity to perform endotracheal intubation (Wang HE, Garza AG)
Measured: Approximately 1 year
Intubation time
Intubation time: defined as the time between insertion of the laryngoscope into the oral cavity and the first appearance of end-tidal CO2.
Ease of intubation: defined as the anesthetist's subjective assessment after finishing the intubation procedure as: (1) very easy; (2) easy; (3) medium; (4) difficult; and (5) impossible. (Ruetzler K) to.
Measured: Approximately 1 year
Ease of intubation
Ease of intubation: defined as the anesthetist's subjective assessment after finishing the intubation procedure as: (1) very easy; (2) easy; (3) medium; (4) difficult; and (5) impossible. (Ruetzler K)
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevsehir Public Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif Yazar, MD, Nevsehir Public Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213389
- Sponsor's protocol ID
- 2023/1011
- Status last verified
- Nov 2024
- First submitted
- 5 Sep 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aziz MF, Dillman D, Fu R, Brambrink AM. Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway. Anesthesiology. 2012 Mar;116(3):629-36. doi: 10.1097/ALN.0b013e318246ea34.
PubMed 22261795Butler PJ, Dhara SS. Prediction of difficult laryngoscopy: an assessment of the thyromental distance and Mallampati predictive tests. Anaesth Intensive Care. 1992 May;20(2):139-42. doi: 10.1177/0310057X9202000202.
PubMed 1595845Garza AG, Gratton MC, Coontz D, Noble E, Ma OJ. Effect of paramedic experience on orotracheal intubation success rates. J Emerg Med. 2003 Oct;25(3):251-6. doi: 10.1016/s0736-4679(03)00198-7.
PubMed 14585451Khan ZH, Kashfi A, Ebrahimkhani E. A comparison of the upper lip bite test (a simple new technique) with modified Mallampati classification in predicting difficulty in endotracheal intubation: a prospective blinded study. Anesth Analg. 2003 Feb;96(2):595-9, table of contents. doi: 10.1097/00000539-200302000-00053.
PubMed 12538218Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.
PubMed 28118659Lewis SR, Butler AR, Parker J, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation. Cochrane Database Syst Rev. 2016 Nov 15;11(11):CD011136. doi: 10.1002/14651858.CD011136.pub2.
PubMed 27844477
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy in Patients Considering Difficult Intubation
- ClinicalTrials.gov ID
- NCT06213389
- Acronym / sponsor ID
- 2023/1011
- Keywords
- Intubation, Difficult, Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nevsehir Public HospitalOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 19 Jan 2024 (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.
The aim of this study is to compare the EzVision® videoryngoscope with conventional laryngoscopy using a Macintosh blade in patients with suspected difficult intubation. This study primarily aims to test the hypothesis that laryngoscopy image is better with EzVision® videoryngoscopy compared to direct laryngoscopy. The secondary hypothesis is also to test the view that, compared to direct laryngoscopy, EzVision® videolingoscopy will improve intubation success, reduce intubation attempts, shorten intubation time, facilitate intubation, and cause less additional complications such as bleeding or sore throat.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients to entubate with EzVision® videolaryngoscopy | Experimental | Device: EzVision® videolaryngoscopyPatients will intubate with EzVision® videolaryngoscopy |
| Patients to intubate with Macintosh blade | Other | Device: Macintosh BladePatients will intubate with Macintosh blade |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 65 years old;
- American Association of Anesthesiologists (ASA) physical condition I-II-III;
- Elective surgery requiring oral endotracheal intubation for general anesthesia;
- Compliance with one of the difficult intubation estimation criteria (if more than one)
- Expected extubation in the operating room
Key exclusion criteria (8 listed)
- Refusal to participate in research;
- Age <18 and >65
- ASA IV and above
- Emergency cases
- Body Mass Index (BMI) > 40 kg/m2.
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 |
|---|---|---|
| EzVision® videolaryngoscopyPatient will be intubated with EzVision® videolaryngoscopy | Device | Patients to entubate with EzVision® videolaryngoscopy |
| Macintosh BladePatient will be intubated with Macintosh Blade | Device | Patients to intubate with Macintosh blade |
Primary outcome
Glottis viewing
Time frame: Approximately 1 year
Glottical viewing will be measured by Modified Cormack Lehane grading. In this scoring system, number 1 indicates the best appearance, while number 4 indicates the worst situation where the glottis is not visible. This measurement have no specific value, but it evaluates glottis opening as visually. 1. Fill view of the glottis 2a. Partial view of the glottis 2b. Arytenoids or posterior part of the vocal cords only visible 3. Only epiglottis visible 4. Neither glottis nor epiglottis visible
4 secondary outcomes
Intubation failure
Time frame: Approximately 1 year
Attempted intubation
Time frame: Approximately 1 year
Intubation time
Time frame: Approximately 1 year
Ease of intubation
Time frame: Approximately 1 year
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 22 Nov 2024.
- Results publication: PubMed 22261795Aziz MF, Dillman D, Fu R, Brambrink AM. Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway. Anesthesiology. 2012 Mar;116(3):629-36. doi: 10.1097/ALN.0b013e318246ea34.
- Results publication: PubMed 1595845Butler PJ, Dhara SS. Prediction of difficult laryngoscopy: an assessment of the thyromental distance and Mallampati predictive tests. Anaesth Intensive Care. 1992 May;20(2):139-42. doi: 10.1177/0310057X9202000202.
- Results publication: PubMed 14585451Garza AG, Gratton MC, Coontz D, Noble E, Ma OJ. Effect of paramedic experience on orotracheal intubation success rates. J Emerg Med. 2003 Oct;25(3):251-6. doi: 10.1016/s0736-4679(03)00198-7.
- Results publication: PubMed 12538218Khan ZH, Kashfi A, Ebrahimkhani E. A comparison of the upper lip bite test (a simple new technique) with modified Mallampati classification in predicting difficulty in endotracheal intubation: a prospective blinded study. Anesth Analg. 2003 Feb;96(2):595-9, table of contents. doi: 10.1097/00000539-200302000-00053.
- Results publication: PubMed 28118659Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.
- Results publication: PubMed 27844477Lewis SR, Butler AR, Parker J, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation. Cochrane Database Syst Rev. 2016 Nov 15;11(11):CD011136. doi: 10.1002/14651858.CD011136.pub2.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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 EzVision® videolaryngoscopy and Macintosh Blade in people with Intubation; Difficult or Failed and Airway Complication of Anesthesia, run by Nevsehir Public 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 5 inclusion and 8 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 22 Nov 2024. 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?
Glottis viewing (time frame: Approximately 1 year). 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 NCT06213389, which also lists 6 linked publications.
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 22 Nov 2024.