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

Intubation; Difficult or Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843565
• Other study ID #: BIO-2022-0348
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: American University of Beirut Medical Center
• Contact: Marie Aouad-Maroun, MD
• Phone: +9611350000
• Email: mm01[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

Device:
• Cobalt video laryngoscope blade
Non-standard hyperangulated Cobalt video laryngoscope blade
• Miller video laryngoscope blade
Standard Miller video laryngoscope blade

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POGO %	Percentage of Glottic Opening	Intraoperatively
Secondary	C&L classification	Cormack and Lehane classification for glottic view.	Intraoperatively
Secondary	Type of blade used for successful intubation	Miller blade or Cobalt blade	Intraoperatively
Secondary	Intubation attempts	Number of intubation attempts.	Intraoperatively
Secondary	Time to successful tracheal intubation	Anesthesia timeline (seconds) from first intubation attempt to first EtCO2 detection	Intraoperatively
Secondary	Adverse events during intubation	Occurrence of events such as: Desaturation (SpO2 < 95%) and bradycardia.	Intraoperatively