AnesthesiaNCT06649526
Comparison of Two Different Video Laryngoscopes
An observational study of Anesthesia, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to answer the question of whether direct laryngoscopy can be performed with videolaryngoscopes. How do the videos of the laryngoscopes provide images directly in laryngoscopy? Primary objective: To compare the images of Hugemed and Mcgrath videolarinygoscope in direct laryngoscopy and indirect… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- endotracheal intubation with videolaryngoscope
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Nov 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: After Ethics Committee approval and written informed consent were obtained, the study will be conducted with 70 patients aged 18-65 years and older of both sexes with American Society of Anaesthesiologists (ASA) physical status I-III. Patients will be divided into two groups by closed envelope method. McGrath video laryngoscope (MG) will be used in patients in group MC; Modified Cormack Lehane score and POGO score in direct laryngoscopic images and Modified Cormack Lehane score and POGO score in indirect laryngoscopic images of the patients will be evaluated and recorded and then orotracheal intubation will be performed. Hugemed videolaryngoscope (HG) will be used in patients in group H and orotracheal intubation will be performed after the Modified Cormack Lehane scores and POGO scores obtained from direct laryngoscopic and indirect laryngoscopic images of the patients are recorded.
Who may be able to join
- To be between 18 -65 years old Mallampati score I-II Cormack-Lehane score I-II ASA physical status I-II who required endotracheal intubation for elective surgery
- Exclusion criteria Pregnancy Mallampati score III-IV Cormack-Lehane score III-IV ASA physical score III-IV sternomental distance < 12.5 cm mandibular-hyoid distance < 6 cm
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Kartal Dr. Lütfi Kirdar City Hospital Cevizli D-100 Güney Yanyol, No:47 Kartal Istanbul Turkey
Istanbul, 34870
About this study
Official title: Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
The aim of this study is to answer the question of whether direct laryngoscopy can be performed with videolaryngoscopes. How do the videos of the laryngoscopes provide images directly in laryngoscopy? Primary objective: To compare the images of Hugemed and Mcgrath videolarinygoscope in direct laryngoscopy and indirect laryngoscopy secondary objective: to compare the effects on haemodynamic response Participants :people who are not expected to have difficult intubation
Read the detailed description
Direct and indirect images of hugemed and McGrath videolaryngoscope during intubation, haemodynamic responses, procedure time will be compared
- Conditions
- Anesthesia
- Being tested
- endotracheal intubation with videolaryngoscope
- Keywords
- video laryngoscopy, airway management, intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal intubation with videolaryngoscopeOther
The present study will compare the images of two different VLs with Macintosh blades (the McGrath videolaryngoscope and the Hugemed videolaryngoscope) in both indirect (screen images) and direct (images viewed through the mouth) laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Group MC McGrath videolaryngoscope Group H Hugmed Videolaryngoscope | All patients will receive intravenous premedication with midazolam 0.03 mg/kg approximately 30 minutes before induction of anaesthesia. Preoperatively, standard monitoring included a 3-lead electrocardiogram (ECG) with continuous ST-segment analysis and assessment of peripheral oxygen saturation (SpO2) and intermittent non-invasive blood pressure. Following preoxygenation with 100% oxygen for three minutes, general anaesthesia would be induced with propofol (3mg/kg) a few minutes after injection of fentanyl (2µg/kg). Neuromuscular paralysis will be induced with rocuronium (0.5 mg/kg) in all patients.In group MC, direct and indirect Modified Cormack Lehane score and POGO score will be evaluated with McGrath videolaryngoscope.
In Group H, direct and indirect Modified Cormack Lehane score and POGO score will be evaluated with Hugemed videolaryngoscope. Receives: Other: endotracheal intubation with videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
Videolaryngoscopy (VL) is a frequently used method in airway management to improve the success of tracheal intubation in recent years. VLs have a miniature video camera at the tip of the blades which allows indirect visualisation of the glottis (1,2,3).
The American Society of Anaesthesiologists (ASA) recommends that a VL should be available and used for all patients with a particularly difficult airway and for whom intubation is planned In recent years, a number of VLs have emerged that offer several advantages over direct laryngoscopy.It is aimed to compare direct and indirect images of mcgrath and hugemed videolaryngoscope.
Measured: 3 months
Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
The principal objective of this study was to undertake a comparative analysis of the images produced by two distinct VLs during direct and indirect laryngoscopy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
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 AnesthesiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Özlem Sezen, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649526
- Sponsor's protocol ID
- Sezen
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sezen O, Simsek T, Simsek AK, Arslan G, Saracoglu KT, Saracoglu A. Comparison of direct and indirect images and hemodynamic response of two different video laryngoscopes to tracheal intubation. BMC Anesthesiol. 2025 Feb 20;25(1):86. doi: 10.1186/s12871-025-02966-7.
PubMed 39979796
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
- ClinicalTrials.gov ID
- NCT06649526
- Acronym / sponsor ID
- Sezen
- Conditions
- Anesthesia
- Keywords
- video laryngoscopy, airway management, intubation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 18 Oct 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 answer the question of whether direct laryngoscopy can be performed with videolaryngoscopes. How do the videos of the laryngoscopes provide images directly in laryngoscopy? Primary objective: To compare the images of Hugemed and Mcgrath videolarinygoscope in direct laryngoscopy and indirect laryngoscopy secondary objective: to compare the effects on haemodynamic response Participants :people who are not expected to have difficult intubation
Detailed description
Direct and indirect images of hugemed and McGrath videolaryngoscope during intubation, haemodynamic responses, procedure time will be compared
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group MC McGrath videolaryngoscope Group H Hugmed Videolaryngoscope | – | Other: endotracheal intubation with videolaryngoscopeAll patients will receive intravenous premedication with midazolam 0.03 mg/kg approximately 30 minutes before induction of anaesthesia. Preoperatively, standard monitoring included a 3-lead electrocardiogram (ECG) with continuous ST-segment analysis and assessment of peripheral oxygen saturation (SpO2) and intermittent non-invasive blood pressure. Following preoxygenation with 100% oxygen for three minutes, general anaesthesia would be induced with propofol (3mg/kg) a few minutes after injection of fentanyl (2µg/kg). Neuromuscular paralysis will be induced with rocuronium (0.5 mg/kg) in all patients.In group MC, direct and indirect Modified Cormack Lehane score and POGO score will be evaluated with McGrath videolaryngoscope. In Group H, direct and indirect Modified Cormack Lehane score and POGO score will be evaluated with Hugemed videolaryngoscope. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- After Ethics Committee approval and written informed consent were obtained, the study will be conducted with 70 patients aged 18-65 years and older of both sexes with American Society of Anaesthesiologists (ASA) physical status I-III. Patients will be divided into two groups by closed envelope method. McGrath video laryngoscope (MG) will be used in patients in group MC; Modified Cormack Lehane score and POGO score in direct laryngoscopic images and Modified Cormack Lehane score and POGO score in indirect laryngoscopic images of the patients will be evaluated and recorded and then orotracheal intubation will be performed. Hugemed videolaryngoscope (HG) will be used in patients in group H and orotracheal intubation will be performed after the Modified Cormack Lehane scores and POGO scores obtained from direct laryngoscopic and indirect laryngoscopic images of the patients are recorded.
Key inclusion criteria (2 listed)
- To be between 18 -65 years old Mallampati score I-II Cormack-Lehane score I-II ASA physical status I-II who required endotracheal intubation for elective surgery
- Exclusion criteria Pregnancy Mallampati score III-IV Cormack-Lehane score III-IV ASA physical score III-IV sternomental distance < 12.5 cm mandibular-hyoid distance < 6 cm
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| endotracheal intubation with videolaryngoscopeThe present study will compare the images of two different VLs with Macintosh blades (the McGrath videolaryngoscope and the Hugemed videolaryngoscope) in both indirect (screen images) and direct (images viewed through the mouth) laryngoscopy. | Other | Group MC McGrath videolaryngoscope Group H Hugmed Videolaryngoscope |
Primary outcome
Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
Time frame: 3 months
Videolaryngoscopy (VL) is a frequently used method in airway management to improve the success of tracheal intubation in recent years. VLs have a miniature video camera at the tip of the blades which allows indirect visualisation of the glottis (1,2,3). The American Society of Anaesthesiologists (ASA) recommends that a VL should be available and used for all patients with a particularly difficult airway and for whom intubation is planned In recent years, a number of VLs have emerged that offer several advantages over direct laryngoscopy.It is aimed to compare direct and indirect images of mcgrath and hugemed videolaryngoscope.
Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
Time frame: 3 months
The principal objective of this study was to undertake a comparative analysis of the images produced by two distinct VLs during direct and indirect laryngoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 39979796Sezen O, Simsek T, Simsek AK, Arslan G, Saracoglu KT, Saracoglu A. Comparison of direct and indirect images and hemodynamic response of two different video laryngoscopes to tracheal intubation. BMC Anesthesiol. 2025 Feb 20;25(1):86. doi: 10.1186/s12871-025-02966-7.
- 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?
An observational study of Anesthesia, run by Dr. Lutfi Kirdar Kartal Training 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 0 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: under way, not looking for participants, as of the sponsor's last update on 18 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT06649526, 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 18 Oct 2024.