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CompletedNCT06581705Updated Sep 19, 2024

The C-MAC Video Laryngoscope Helps Presbyopic Anesthetists

An interventional study of Video Laryngoscope in Presbyopia, sponsored by Egymedicalpedia. Completed at 1 site in Egypt. Open to participants aged 2 Months to 12 Months. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Egymedicalpedia · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Jan 2021, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Months to 12 Months
Sex
All
01

Study 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 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

02

Conditions studied

  • Presbyopia

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03

In context

Presbyopia

324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.

This study's enrollment of 100 is above the median of 61 across 265 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Egymedicalpedia is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Pediatric Patients whom scheduled for surgical procedures under general inhalation anesthesia

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Group A: (video laryngoscope Group)

    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. .

    Procedure: Video Laryngoscope

  • Active comparator
    Group B: (Standard laryngoscope Group)

    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. .

    Procedure: Video Laryngoscope

Interventions

  • ProcedureVideo Laryngoscope

    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).

06

What researchers measure

Primary outcomes

  1. the frequency of successful intubation

    The frequency of the need for external laryngeal manipulation, head extension, or stylet curvature change to achieve intubation

    Time frame: 30 seconds

07

Study locations

1 site
  • Al-Azhar University hospitals
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06581705
Lead sponsor
Egymedicalpedia
Collaborators
Al-Azhar University
Responsible party
Sponsor
First posted
Sep 3, 2024
Start date
Jan 5, 2021
Primary completion
Jan 1, 2024
Completion
Jan 10, 2024
Last update
Sep 19, 2024

Study contacts

Ahmed M.Elnagar, M.D
principal investigator · Al-Azhar University, Faculty of medicine for boys

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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