The C-MAC Video Laryngoscope Helps Presbyopic Anesthetists

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Procedure: Video Laryngoscope

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al-Azhar University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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).
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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the frequency of successful intubation	The frequency of the need for external laryngeal manipulation, head extension, or stylet curvature change to achieve intubation	30 seconds

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Collaborators: Al-Azhar University
• Investigators: Principal Investigator: Ahmed M.Elnagar, M.D, Al-Azhar University, Faculty of medicine for boys

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 31, 2024
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: The C-MAC Video

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No