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

Standard Versus Hyperangulated Video Laryngoscopy Blades for Intubation in Neonates and Small Infants: Evaluation of the Glottic View

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed
• Intervention / Treatment: Device: Non-standard blade (NSB); Device: Standard blade (SB)

Detailed Description

A higher incidence of difficult airway has been reported in neonates and infants than in adults. Optimizing glottic view during tracheal intubation is very challenging in neonates and small infants and it is not clear whether the design of the intubating blade using video laryngoscopy has a major influence of the glottic view and subsequently on the success of intubation.

The primary objective of this study 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. The secondary objectives are the first attempt success rate at intubation, the number of attempts, the time to successful intubation, and the occurrence of adverse events during intubation, such as desaturation or bradycardia.

In this prospective randomized cross over clinical trial, 40 (20 in each group) neonates or small infants with body weight ≤ 5 kg or age ≤ 3 months will be enrolled in one of two groups over 1 year of work. In patients allocated to the Cobalt group, the POGO and Cormack and Lehane (C&L) classification will be recorded using video laryngoscopy with a Cobalt blade followed by an assessment using the Miller blade. In patients allocated to the Miller group, the POGO and C&L classification will be recorded using video laryngoscopy with a Miller blade followed by an assessment using the Cobalt blade. In both groups, intubation will be attempted during the second assessment. If the first attempt at intubation fails, the subsequent attempts will be left at the discretion of the attending anesthesiologist.

Data comparing straight and hyperangulated video laryngoscopy blades in neonates and small infants are limited. Both techniques are standard of care at our institution. This study will identify the technique that provides optimal glottic views and intubating conditions in this patient population, and thus improved patient's safety.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Neonates or small infants with body weight ≤ 5 kg or age ≤ 3 months, scheduled for elective surgery under general anesthesia.
• ASA (American Society of Anesthesiologists) class I-III patients.

Exclusion Criteria:

• Patients with a history of difficult airway or with craniofacial and airway anomalies.
• ASA (American Society of Anesthesiologists) class IV patients.
• Recent respiratory tract infection within the last 2 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence of NSB first; In patients allocated to the sequence of NSB first, the POGO and C&L classification will be recorded using video laryngoscopy with the hyperangulated blade 2 followed by an assessment using the Miller blade 0 or 1. Intubation will then be attempted during the second assessment. Endotracheal tube size will be selected according to body weight and a guiding stylet will be used. If the first attempt at intubation fails, the subsequent attempts will be left at the discretion of the attending anesthesiologist.	Device: Non-standard blade (NSB); GlideScope® VL (Verathon Inc, WA, USA) hyperangulated blade 2; Device: Standard blade (SB); standard Miller blade 0 or 1
Placebo Comparator: Sequence of SB first; In patients allocated to the Miller group, the POGO and C&L classification will be recorded using video laryngoscopy with a Miller blade 0 or 1 followed by an assessment using the Cobalt blade 2. Intubation will then be attempted during the second assessment. Endotracheal tube size will be selected according to body weight and a guiding stylet will be used. If the first attempt at intubation fails, the subsequent attempts will be left at the discretion of the attending anesthesiologist.	Device: Non-standard blade (NSB); GlideScope® VL (Verathon Inc, WA, USA) hyperangulated blade 2; Device: Standard blade (SB); standard Miller blade 0 or 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POGO %	Percentage of Glottic Opening	Intraoperatively
C&L classification	Cormack and Lehane classification for glottic view.	Intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation attempts	Number of intubation attempts.	Intraoperatively
Time to successful tracheal intubation	Anesthesia timeline (seconds) from first intubation attempt to first EtCO2 detection	Intraoperatively
Adverse events during intubation	Occurrence of events such as: Desaturation (SpO2 < 95%) and bradycardia.	Intraoperatively

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Marie Aouad-Maroun, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Actual): October 29, 2025
• Study Completion (Actual): October 29, 2025

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pediatrics; Intubation; Laryngoscopy; Neonates
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Cobalt
• Other Study ID Numbers: BIO-2022-0348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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