VideolaryngoscopyVLNCT06349005
Laryngoscopy and Coronary Artery Bypass Graft Surgery
A study testing Tracheal intubation using Storz VL, Tracheal intubation using Macintosh laryngoscopy and Tracheal intubation using MacGrath VL in people with Videolaryngoscopy, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Videolaryngoscopy
- What is being tested?
- Tracheal intubation using Storz VL, Tracheal intubation using Macintosh laryngoscopy and Tracheal intubation using MacGrath VL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2025to 28 May 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range between 18 and 75 years.
- Scheduled for elective coronary artery bypass surgery.
- Classified under American Society of Anesthesiologists (ASA) physical status II-III.
- Patients with no history of difficult intubation or associated risk factors.
Who cannot join
- Emergency case
- Predicted difficult airways
- Body mass index > 35 kilograms per meter squared
- Baseline hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Response to Various Laryngoscopes During Tracheal Intubation in CABG Patients
In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).
Read the detailed description
During endotracheal intubation, laryngoscopy can significantly affect hemodynamic responses, including tachycardia and elevated blood pressure, which may be particularly detrimental to individuals with cardiovascular conditions. Various studies have explored the hemodynamic reactions associated with laryngeal stimulation through different intubation devices. Researchers hypothesize that endotracheal intubation using video laryngoscopy will elicit a reduced hemodynamic response compared to traditional (Macintosh) laryngoscopy. In this prospective and randomized clinical study, the purpose is to compare the Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope concerning haemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).
- Conditions
- Videolaryngoscopy
- Being tested
- Tracheal intubation using Storz VL, Tracheal intubation using Macintosh laryngoscopy, Tracheal intubation using MacGrath VL, Tracheal intubation using EzVision VL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubation using Storz VLOther
Video-assisted intubation technique using Storz VL
Tracheal intubation using Macintosh laryngoscopyOther
Traditional intubation technique using Macintosh laryngoscopy
Tracheal intubation using MacGrath VLOther
Video-assisted intubation technique using MacGrath VL
Tracheal intubation using EzVision VLOther
Video-assisted intubation technique using EzVision VL
| Study group | Role | What they receive |
|---|---|---|
| Group Storz VL | Active comparator | Patients will undergo intubation with the Storz Videolaryngoscope®, during which their hemodynamic responses will be documented. Receives: Other: Tracheal intubation using Storz VL |
| Group MacGrath VL | Active comparator | Patients will undergo intubation with the McGrath Videolaryngoscope®, during which their hemodynamic responses will be documented. Receives: Other: Tracheal intubation using MacGrath VL |
| Group EzVision VL | Active comparator | Patients will undergo intubation with the EzVision Videolaryngoscope®, during which their hemodynamic responses will be documented. Receives: Other: Tracheal intubation using EzVision VL |
| Group Traditional | Active comparator | Patients will undergo intubation with the traditional (Macintosh) laryngoscopy, during which their hemodynamic responses will be documented. Receives: Other: Tracheal intubation using Macintosh laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic response
Change from baseline invasive blood pressure
Measured: Change from baseline Systolic or Diastolic or mean Blood Pressure at 10 minutes
Hemodynamic response
Change from baseline heart rate
Measured: Change from baseline heart rate at 10 minutes
Secondary outcomes (2)
Intubation time
The duration from when the laryngoscope passes through the teeth until it is withdrawn back to the teeth will be measured.
Measured: 180 seconds
Visualization of the glottis
According to Cormack Lehane classification four grades (1-4). The higher the grade, the higher the likelihood of difficult intubation.
Measured: 180 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start12 Jan 2025
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VideolaryngoscopyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349005
- Sponsor's protocol ID
- 111
- Acronym
- VL
- Status last verified
- May 2025
- First submitted
- 26 Feb 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Response to Various Laryngoscopes During Tracheal Intubation in CABG Patients
- ClinicalTrials.gov ID
- NCT06349005
- Acronym / sponsor ID
- VL / 111
- Conditions
- Videolaryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 12 Jan 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 5 Apr 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.
In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).
Detailed description
During endotracheal intubation, laryngoscopy can significantly affect hemodynamic responses, including tachycardia and elevated blood pressure, which may be particularly detrimental to individuals with cardiovascular conditions. Various studies have explored the hemodynamic reactions associated with laryngeal stimulation through different intubation devices. Researchers hypothesize that endotracheal intubation using video laryngoscopy will elicit a reduced hemodynamic response compared to traditional (Macintosh) laryngoscopy. In this prospective and randomized clinical study, the purpose is to compare the Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope concerning haemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Storz VL | Active comparator | Other: Tracheal intubation using Storz VLPatients will undergo intubation with the Storz Videolaryngoscope®, during which their hemodynamic responses will be documented. |
| Group MacGrath VL | Active comparator | Other: Tracheal intubation using MacGrath VLPatients will undergo intubation with the McGrath Videolaryngoscope®, during which their hemodynamic responses will be documented. |
| Group EzVision VL | Active comparator | Other: Tracheal intubation using EzVision VLPatients will undergo intubation with the EzVision Videolaryngoscope®, during which their hemodynamic responses will be documented. |
| Group Traditional | Active comparator | Other: Tracheal intubation using Macintosh laryngoscopyPatients will undergo intubation with the traditional (Macintosh) laryngoscopy, during which their hemodynamic responses will be documented. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range between 18 and 75 years.
- Scheduled for elective coronary artery bypass surgery.
- Classified under American Society of Anesthesiologists (ASA) physical status II-III.
- Patients with no history of difficult intubation or associated risk factors.
Key exclusion criteria (4 listed)
- Emergency case
- Predicted difficult airways
- Body mass index > 35 kilograms per meter squared
- Baseline hemodynamic instability
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 |
|---|---|---|
| Tracheal intubation using Storz VLVideo-assisted intubation technique using Storz VL | Other | Group Storz VL |
| Tracheal intubation using Macintosh laryngoscopyTraditional intubation technique using Macintosh laryngoscopy | Other | Group Traditional |
| Tracheal intubation using MacGrath VLVideo-assisted intubation technique using MacGrath VL | Other | Group MacGrath VL |
| Tracheal intubation using EzVision VLVideo-assisted intubation technique using EzVision VL | Other | Group EzVision VL |
Primary outcome
Hemodynamic response
Time frame: Change from baseline Systolic or Diastolic or mean Blood Pressure at 10 minutes
Change from baseline invasive blood pressure
Hemodynamic response
Time frame: Change from baseline heart rate at 10 minutes
Change from baseline heart rate
2 secondary outcomes
Intubation time
Time frame: 180 seconds
Visualization of the glottis
Time frame: 180 seconds
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 29 May 2025.
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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 Tracheal intubation using Storz VL, Tracheal intubation using Macintosh laryngoscopy and Tracheal intubation using MacGrath VL in people with Videolaryngoscopy, run by Konya Meram State 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 4 inclusion and 4 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 29 May 2025. 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?
Hemodynamic response (time frame: Change from baseline Systolic or Diastolic or mean Blood Pressure at 10 minutes). 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?
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 29 May 2025.