Difficult IntubationNCT06484517
Is HugeMed Video Laryngoscope Superior to McGrath in Pediatric Patients
A study testing Hugemed Videolaryngoscope in people with Difficult Intubation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Videolaryngoscopes improve laryngeal visualization in children under 3 years. In this study we aimed to compare Hugemed and McGrath videolaryngoscopes regarding their Cormach-Lehane (CL) and percentage of glottic opening (POGO) scores. Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Hugemed Videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 31 Jan 2023
- 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 6 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- total of 40 elective surgical patients under the age of 3, classified as ASA 1-3 risk group, who underwent general anesthesia with no anticipated difficult airway.
Who cannot join
- Patients who could not obtain parental consent, those classified as ASA 4 and above, individuals with serious cardiac and respiratory problems, and patients anticipated to have a difficult airway were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Research and Training Hospital
Istanbul
About this study
Videolaryngoscopes improve laryngeal visualization in children under 3 years. In this study we aimed to compare Hugemed and McGrath videolaryngoscopes regarding their Cormach-Lehane (CL) and percentage of glottic opening (POGO) scores. Furthermore, tracheal intubation success rates, need for cricoid pressure and optimization maneuvers, and hemodynamic changes are compared.
- Conditions
- Difficult Intubation
- Being tested
- Hugemed Videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hugemed VideolaryngoscopeDevice
Also called Mc Grath Videolaryngoscope
After general anesthesia induction, the first group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope. For the second group (Group H, n=20), the Hugemed videolaryngoscope was used. Patients were intubated using one of the appropriate blades numbered 1, 2, or 3 based on their height, weight, and age.
| Study group | Role | What they receive |
|---|---|---|
| The group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope. | Active comparator | Before intubation, Cormack-Lehane score and percentage of glottis opening (POGO) score were recorded by applying direct and indirect laryngoscopy with the Macgreth videolaryngoscope. All tracheal intubations were performed by the same expert with over 10 years of experience in pediatric anesthesia. Receives: Device: Hugemed Videolaryngoscope |
| For the group (Group H, n=20), the Hugemed videolaryngoscope was used. | Experimental | Patients were intubated using one of the appropriate blades numbered 1, 2, or 3 based on their height, weight, and age. After the induction of general anesthesia, patients underwent direct and indirect laryngoscopy with videolaryngoscopes. The Modified Cormack-Lehane score and Percentage of Glottic Opening (POGO) score were recorded, and orotracheal intubation was performed. Number of attempts, need for cricoid pressure, optimization maneuvers, success rate, and hemodynamic parameters of both groups were recorded. Receives: Device: Hugemed Videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of intubation
Number of attempts of the intubation.
Measured: Procedure (At the time of the intubation of the patient.)
Secondary outcomes (5)
Percentage of glottis opening (POGO)
The primary aim of this study was to compare the percentage of glottis opening (POGO, 0-100%) scores in direct and indirect laryngoscopy performed with HugeMed and McGrath video laryngoscopes in pediatric patients.
Measured: Procedure (At the time of the intubation of the patient.)
Need for optimization maneuvers
Whether there are any optimization maneuvers by an assistant.
Measured: Procedure (At the time of the intubation of the patient.)
Degree of hemodynamic changes
Whether there are any acute changes in the patient heart rate during the intubation.
Measured: Procedure (At the time of the intubation of the patient.)
blood pressure
Whether there are any acute changes in the patient blood pressure during the intubation.
Measured: Procedure (At the time of the intubation of the patient.)
Success of intubation
Number of attempts of the intubation.
Measured: Procedure (At the time of the intubation of the patient.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Mar 2022
- Primary completion1 Oct 2022
- Study completion31 Jan 2023
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 Difficult IntubationStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Tanırgan Çabaklı, Marmara University
- Investigators
- Gamze Çabaklı, Principal investigator, Marmara University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484517
- Sponsor's protocol ID
- 09.2021.961
- Status last verified
- Jul 2024
- First submitted
- 16 Jun 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabakli GT, Saracoglu KT, Abdullayev R, Guclu E, Ratajczyk P, Saracoglu A. A Comparison of McGrath Mac and HugeMed Video Laryngoscopes in Pediatric Patients Under 3 Years Old-A Prospective Randomized Trial. Healthcare (Basel). 2025 Apr 7;13(7):842. doi: 10.3390/healthcare13070842.
PubMed 40218139
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is HugeMed Video Laryngoscope Superior to McGrath in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06484517
- Acronym / sponsor ID
- 09.2021.961
- Conditions
- Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 3 Jul 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.
Videolaryngoscopes improve laryngeal visualization in children under 3 years. In this study we aimed to compare Hugemed and McGrath videolaryngoscopes regarding their Cormach-Lehane (CL) and percentage of glottic opening (POGO) scores. Furthermore, tracheal intubation success rates, need for cricoid pressure and optimization maneuvers, and hemodynamic changes are compared.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope. | Active comparator | Device: Hugemed VideolaryngoscopeBefore intubation, Cormack-Lehane score and percentage of glottis opening (POGO) score were recorded by applying direct and indirect laryngoscopy with the Macgreth videolaryngoscope. All tracheal intubations were performed by the same expert with over 10 years of experience in pediatric anesthesia. |
| For the group (Group H, n=20), the Hugemed videolaryngoscope was used. | Experimental | Device: Hugemed VideolaryngoscopePatients were intubated using one of the appropriate blades numbered 1, 2, or 3 based on their height, weight, and age. After the induction of general anesthesia, patients underwent direct and indirect laryngoscopy with videolaryngoscopes. The Modified Cormack-Lehane score and Percentage of Glottic Opening (POGO) score were recorded, and orotracheal intubation was performed. Number of attempts, need for cricoid pressure, optimization maneuvers, success rate, and hemodynamic parameters of both groups were recorded. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- total of 40 elective surgical patients under the age of 3, classified as ASA 1-3 risk group, who underwent general anesthesia with no anticipated difficult airway.
Key exclusion criteria (1 listed)
- Patients who could not obtain parental consent, those classified as ASA 4 and above, individuals with serious cardiac and respiratory problems, and patients anticipated to have a difficult airway were not included in 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 |
|---|---|---|
| Hugemed VideolaryngoscopeAlso: Mc Grath VideolaryngoscopeAfter general anesthesia induction, the first group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope. For the second group (Group H, n=20), the Hugemed videolaryngoscope was used. Patients were intubated using one of the appropriate blades numbered 1, 2, or 3 based on their height, weight, and age. | Device | For the group (Group H, n=20), the Hugemed videolaryngoscope was used., The group of patients (Group M, n=20) was intubated with the McGrath videolaryngoscope. |
Primary outcome
Success of intubation
Time frame: Procedure (At the time of the intubation of the patient.)
Number of attempts of the intubation.
5 secondary outcomes
Percentage of glottis opening (POGO)
Time frame: Procedure (At the time of the intubation of the patient.)
Need for optimization maneuvers
Time frame: Procedure (At the time of the intubation of the patient.)
Degree of hemodynamic changes
Time frame: Procedure (At the time of the intubation of the patient.)
blood pressure
Time frame: Procedure (At the time of the intubation of the patient.)
Success of intubation
Time frame: Procedure (At the time of the intubation of the patient.)
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 20 Jan 2025.
- Derived from this study: PubMed 40218139Cabakli GT, Saracoglu KT, Abdullayev R, Guclu E, Ratajczyk P, Saracoglu A. A Comparison of McGrath Mac and HugeMed Video Laryngoscopes in Pediatric Patients Under 3 Years Old-A Prospective Randomized Trial. Healthcare (Basel). 2025 Apr 7;13(7):842. doi: 10.3390/healthcare13070842.
- 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.
Gamze Çabaklı principal investigator
Marmara University Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hugemed Videolaryngoscope in people with Difficult Intubation, run by Marmara 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 20 Jan 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?
Success of intubation (time frame: Procedure (At the time of the intubation of the patient.)). 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 NCT06484517, 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 20 Jan 2025.