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OpenTrials
Completed

NCT Number: NCT06581705

The C-MAC Video Laryngoscope Helps Presbyopic Anesthetists

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.

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Key information

Age range

2 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University hospitals

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video Laryngoscope

Procedure

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).

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Collaborators

  • Al-Azhar University

Registry information

Official study title

The C-MAC Video Laryngoscope Helps Presbyopic Anesthetists to Overcome Difficulty in Neonatal and Infantile Intubation. A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 3, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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