NCT06581705

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
Last Updated

September 19, 2024

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

August 30, 2024

Last Update Submit

September 6, 2024

Conditions

Presbyopia

Outcome Measures

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

    30 seconds

Study Arms (2)

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. .

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. .

Procedure: Video Laryngoscope

Interventions

Video LaryngoscopePROCEDURE

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).

Group A: (video laryngoscope Group)Group B: (Standard laryngoscope Group)

Eligibility Criteria

Age2 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University hospitals

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 39794694DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Ahmed M.Elnagar, M.D

    Al-Azhar University, Faculty of medicine for boys

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2024

First Posted

September 3, 2024

Study Start

January 5, 2021

Primary Completion

January 1, 2024

Study Completion

January 10, 2024

Last Updated

September 19, 2024

Record last verified: 2021-01

Locations

EG(1)