PresbyopiaNCT06581705
The C-MAC Video Laryngoscope Helps Presbyopic Anesthetists
A study testing Video Laryngoscope in people with Presbyopia, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Endotracheal intubation is the de facto gold standard for airway management especially in neonatal and pediatric anesthesia . An efficient neonatal airway management is challenging even in the most experienced hands and the prevalence of difficult intubation in pediatric anesthesia varied greatly on a wide range. Read more about this study
- Who is it for?
- Ages 2 to 12 months
- Conditions the study is for
- Presbyopia
- What is being tested?
- Video Laryngoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2021to 10 Jan 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 2 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric Patients whom scheduled for surgical procedures under general inhalation anesthesia
Who cannot join
- Patients older than 12 months
- patients with Mallampati score of 3 or 4,
- patients had abnormal airway and obstructive sleep apnea,
- manifestations of upper respiratory tract infection or uncompensated cardiopulmonary diseases
- patients with ASA grade >III were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The C-MAC Video Laryngoscope Helps Presbyopic Anesthetists to Overcome Difficulty in Neonatal and Infantile Intubation. A Randomized Controlled Trial
Endotracheal intubation is the de facto gold standard for airway management especially in neonatal and pediatric anesthesia .
An efficient neonatal airway management is challenging even in the most experienced hands and the prevalence of difficult intubation in pediatric anesthesia varied greatly on a wide range.
Read the detailed description
Neonatal intubation is a life-saving procedure, which requires skilled operator but still may cause direct tissue trauma and precipitate adverse reactions. However, intubation with videolaryngoscope (VL) requires less force than with a direct laryngoscope to minimize the possibility of these adverse events.
The recent Brazilian recommendations for management of pediatrics difficult airways included proper assessment, preparation, positioning, pre-oxygenation, minimizing trauma, maintenance of arterial oxygenation and the implementation of the advanced tools as VL, flexible intubating bronchoscopy, and supraglottic devices.
The recent British recommendations also advised for the use VL with an age-adapted standard blade as first choice for tracheal intubation and the use of a stylet to reinforce and preshape tracheal tubes in case of the use of hyperangulated VL blades .
Considering the recent interest in assessing the performance of various VLs in pediatric anesthesia, the C-MAC® (Karl Storz, Germany) VL with standard Miller blade sizes #0 and #1, is a widely used in neonates and infants for its provision of superior-quality glottis view in comparison to the McGrathTM MAC size #1 blade and direct laryngoscopy.
Presbyopia is defined as disordered eye adjustment function and affects middle aged people leading to difficult viewing close objects and is corrected with magnifying lens.
Earlier studies documented that presbyopic aged anesthetists find difficulty when trying to view a patient's larynx at a close distance and this difficulty is surely magnified on dealing with intubation of neonates and children
- Conditions
- Presbyopia
- Being tested
- Video Laryngoscope
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video LaryngoscopeProcedure or surgery
Evaluation of the success rates (SR) of anesthetists aged ≥45 years for intubating neonates and infants using the C-MAC videolaryngoscope (VL) in comparison to the use of the standard laryngoscope (SL).
| Study group | Role | What they receive |
|---|---|---|
| Group A: (video laryngoscope Group) | Active comparator | About 50 anesthetists in charge must be older than 40 years; each anesthetist had to manage at least 10 patients from both groups received endotracheal intubation (ETI) using the SL and VL group had intubated using the C-MAC® (Karl Storz, Germany) VL with the standard Miller blade and flexible Stylet (2 mm PORTEX® stylet; Smiths Medical International Ltd., UK) to strengthen the endotracheal tube (ETT) and adjust its curvature as C-shaped. The study outcomes included the frequency of successful intubation within 30 s (30-s SR) and the number of intubation attempts. . Receives: Procedure: Video Laryngoscope |
| Group B: (Standard laryngoscope Group) | Active comparator | About 50 anesthetists in charge must be older than 40 years; each anesthetist had to manage at least 10 patients from both groups received endotracheal intubation (ETI) using the SL and VL group had intubated using the C-MAC® (Karl Storz, Germany) VL with the standard Miller blade and flexible Stylet (2 mm PORTEX® stylet; Smiths Medical International Ltd., UK) to strengthen the endotracheal tube (ETT) and adjust its curvature as C-shaped. The study outcomes included the frequency of successful intubation within 30 s (30-s SR) and the number of intubation attempts. . Receives: Procedure: Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of successful intubation
The frequency of the need for external laryngeal manipulation, head extension, or stylet curvature change to achieve intubation
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start5 Jan 2021
- Primary completion1 Jan 2024
- Study completion10 Jan 2024
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 PresbyopiaStudies 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor
- Investigators
- Ahmed M.Elnagar, M.D, Principal investigator, Al-Azhar University, Faculty of medicine for boys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581705
- Sponsor's protocol ID
- The C-MAC Video
- Status last verified
- Jan 2021
- First submitted
- 30 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdalla AE, Eissa MM, Elbasyouny MR, Zomra MR, Elnaggar AM, Elsayed MM. The C-MAC video laryngoscope helps presbyopic anesthetists to overcome difficulty in neonatal and infantile intubation: a randomized controlled trial. BMC Anesthesiol. 2025 Jan 10;25(1):24. doi: 10.1186/s12871-024-02841-x.
PubMed 39794694
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The C-MAC Video Laryngoscope Helps Presbyopic Anesthetists to Overcome Difficulty in Neonatal and Infantile Intubation. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06581705
- Acronym / sponsor ID
- The C-MAC Video
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 3 Sep 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.
Endotracheal intubation is the de facto gold standard for airway management especially in neonatal and pediatric anesthesia .
An efficient neonatal airway management is challenging even in the most experienced hands and the prevalence of difficult intubation in pediatric anesthesia varied greatly on a wide range.
Detailed description
Neonatal intubation is a life-saving procedure, which requires skilled operator but still may cause direct tissue trauma and precipitate adverse reactions. However, intubation with videolaryngoscope (VL) requires less force than with a direct laryngoscope to minimize the possibility of these adverse events.
The recent Brazilian recommendations for management of pediatrics difficult airways included proper assessment, preparation, positioning, pre-oxygenation, minimizing trauma, maintenance of arterial oxygenation and the implementation of the advanced tools as VL, flexible intubating bronchoscopy, and supraglottic devices.
The recent British recommendations also advised for the use VL with an age-adapted standard blade as first choice for tracheal intubation and the use of a stylet to reinforce and preshape tracheal tubes in case of the use of hyperangulated VL blades .
Considering the recent interest in assessing the performance of various VLs in pediatric anesthesia, the C-MAC® (Karl Storz, Germany) VL with standard Miller blade sizes #0 and #1, is a widely used in neonates and infants for its provision of superior-quality glottis view in comparison to the McGrathTM MAC size #1 blade and direct laryngoscopy.
Presbyopia is defined as disordered eye adjustment function and affects middle aged people leading to difficult viewing close objects and is corrected with magnifying lens.
Earlier studies documented that presbyopic aged anesthetists find difficulty when trying to view a patient's larynx at a close distance and this difficulty is surely magnified on dealing with intubation of neonates and children
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: (video laryngoscope Group) | Active comparator | Procedure: Video LaryngoscopeAbout 50 anesthetists in charge must be older than 40 years; each anesthetist had to manage at least 10 patients from both groups received endotracheal intubation (ETI) using the SL and VL group had intubated using the C-MAC® (Karl Storz, Germany) VL with the standard Miller blade and flexible Stylet (2 mm PORTEX® stylet; Smiths Medical International Ltd., UK) to strengthen the endotracheal tube (ETT) and adjust its curvature as C-shaped. The study outcomes included the frequency of successful intubation within 30 s (30-s SR) and the number of intubation attempts. . |
| Group B: (Standard laryngoscope Group) | Active comparator | Procedure: Video LaryngoscopeAbout 50 anesthetists in charge must be older than 40 years; each anesthetist had to manage at least 10 patients from both groups received endotracheal intubation (ETI) using the SL and VL group had intubated using the C-MAC® (Karl Storz, Germany) VL with the standard Miller blade and flexible Stylet (2 mm PORTEX® stylet; Smiths Medical International Ltd., UK) to strengthen the endotracheal tube (ETT) and adjust its curvature as C-shaped. The study outcomes included the frequency of successful intubation within 30 s (30-s SR) and the number of intubation attempts. . |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric Patients whom scheduled for surgical procedures under general inhalation anesthesia
Key exclusion criteria (5 listed)
- Patients older than 12 months
- patients with Mallampati score of 3 or 4,
- patients had abnormal airway and obstructive sleep apnea,
- manifestations of upper respiratory tract infection or uncompensated cardiopulmonary diseases
- patients with ASA grade >III were excluded from this 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 |
|---|---|---|
| Video LaryngoscopeEvaluation of the success rates (SR) of anesthetists aged ≥45 years for intubating neonates and infants using the C-MAC videolaryngoscope (VL) in comparison to the use of the standard laryngoscope (SL). | Procedure or surgery | Group A: (video laryngoscope Group), Group B: (Standard laryngoscope Group) |
Primary outcome
the frequency of successful intubation
Time frame: 30 seconds
The frequency of the need for external laryngeal manipulation, head extension, or stylet curvature change to achieve intubation
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 19 Sep 2024.
- Derived from this study: PubMed 39794694Abdalla AE, Eissa MM, Elbasyouny MR, Zomra MR, Elnaggar AM, Elsayed MM. The C-MAC video laryngoscope helps presbyopic anesthetists to overcome difficulty in neonatal and infantile intubation: a randomized controlled trial. BMC Anesthesiol. 2025 Jan 10;25(1):24. doi: 10.1186/s12871-024-02841-x.
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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.
Ahmed M.Elnagar, M.D principal investigator
Al-Azhar University, Faculty of medicine for boys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Laryngoscope in people with Presbyopia, run by Egymedicalpedia at 1 site in Egypt.
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 5 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 19 Sep 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 Egypt. 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?
the frequency of successful intubation (time frame: 30 seconds). 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 NCT06581705, 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 19 Sep 2024.