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Standard Versus Hyperangulated Video Laryngoscopy Blades for Intubation in Neonates and Small Infants

NCT05843565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-01-02

No results posted yet for this study

Summary

The goal of this prospective randomized cross over clinical trial is to compare the difference in the percentage of glottic opening (POGO) between two different video laryngoscopy blades, the hyperangulated Cobalt blade and the straight Miller blade in neonates or small infants with body weight ≤ 5 kg and age ≤ 3 months.

The main questions it aims to answer are:

* Is there a significant difference in the POGO using the standard Miller video laryngoscope blade versus the non-standard hyperangulated Cobalt video laryngoscope blade in neonates and small infants?
* Are there significant differences in the first attempt success rate at intubation, the number of attempts, the time to successful intubation, the type of blade used for successful intubation, and the occurrence of adverse events during intubation, such as episodes of bradycardia or desaturation?

40 (20 in each group) neonates or small infants with body weight ≤ 5 kg or age ≤ 3 months will be enrolled in one of the two groups over 2 years of work.

Researchers will compare the POGO and Cormack and Lehane (C\&L) classification using the hyperangulated Cobalt blade versus the straight Miller blade to identify the technique that provides optimal glottic views and intubating conditions in this patient population, and thus improved patient's safety.

Conditions

  • Intubation; Difficult or Failed

Interventions

DEVICE

Non-standard blade (NSB)

GlideScope® VL (Verathon Inc, WA, USA) hyperangulated blade 2

DEVICE

Standard blade (SB)

standard Miller blade 0 or 1

Sponsors & Collaborators

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Marie Aouad-Maroun, MD · American University of Beirut Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-14
Primary Completion
2025-10-29
Completion
2025-10-29

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843565 on ClinicalTrials.gov