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

NCT ID: NCT05843565

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2025-10-29

Brief 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.

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.

Conditions

Intubation; Difficult or Failed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Non-standard blade (NSB)

Intervention Type: DEVICE

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

Standard blade (SB)

Intervention Type: DEVICE

standard Miller blade 0 or 1

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.

Group Type: PLACEBO_COMPARATOR

Non-standard blade (NSB)

Intervention Type: DEVICE

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

Standard blade (SB)

Intervention Type: DEVICE

standard Miller blade 0 or 1

Interventions

Non-standard blade (NSB)

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

Intervention Type: DEVICE

Standard blade (SB)

standard Miller blade 0 or 1

Intervention Type: DEVICE

Eligibility Criteria

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.

• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dr. Marie Awad

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Aouad-Maroun, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut Medical Center

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

BIO-2022-0348

Identifier Type: -

Identifier Source: org_study_id