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

NCT05843565 | Completed

• 1 other identifier: BIO-2022-0348
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed

Keywords

Intubation; Laryngoscopy; Pediatrics; Neonates

Outcome Measures

Primary Outcomes (2)

• POGO %

  Percentage of Glottic Opening

  Intraoperatively

• C&L classification

  Cormack and Lehane classification for glottic view.

  Intraoperatively

Secondary Outcomes (3)

• Intubation attempts

  Intraoperatively

• Time to successful tracheal intubation

  Intraoperatively

• Adverse events during intubation

  Intraoperatively

Study Arms (2)

Sequence of NSB first

EXPERIMENTAL

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); Device: Standard blade (SB)

Sequence of SB first

PLACEBO COMPARATOR

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); Device: Standard blade (SB)

Interventions

Non-standard blade (NSB) DEVICE

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

Sequence of NSB first; Sequence of SB first

Standard blade (SB) DEVICE

standard Miller blade 0 or 1

Sequence of NSB first; Sequence of SB first

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Study Officials

• Marie Aouad-Maroun, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: June 14, 2023
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)