Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-04

Study Completion Date

2023-11-20

Brief Summary

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Endotracheal intubation is a critical intervention for newborn babies. Laryngoscopy is the crucial part of endotracheal intubation. Traditionally, operators use a standard laryngoscope to view the larynx by looking directly into the mouth (direct laryngoscopy). More recently videolaryngoscopes that have a video camera mounted at the tip of the laryngoscope blade have been developed, Rather than look directly into the mouth, the operator looks at a screen that displays the view acquired by the camera (indirect laryngoscopy). Videolaryngoscopes have been demonstrated to be useful for teaching trainees direct laryngoscopy. However, it may be that all clinicians are more successful with a videolaryngoscope. The investigators will compare whether clinicians who are randomly assigned to intubate newborn infants using a videolaryngoscope are more successful in intubating newborn infants at the first attempt compared to clinicians who are randomly assigned to intubate newborn infants using a standard laryngoscope.

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Detailed Description

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Endotracheal intubation is a critical intervention for newborn babies. Proficiency at intubation has declined markedly in recent decades such that fewer than half of babies are successfully intubated at the first attempt. Laryngoscopy is the crucial part of endotracheal intubation. Traditionally, operators use a standard laryngoscope to view the larynx by looking directly into the mouth (direct laryngoscopy). More recently videolaryngoscopes that have a video camera mounted at the tip of the laryngoscope blade have been developed, Rather than look directly into the mouth, the operator looks at a screen that displays the view acquired by the camera (indirect laryngoscopy). Videolaryngoscopes have been demonstrated to be useful for teaching trainees direct laryngoscopy, i.e. a senior colleague can coach them during the procedure. However, it may be that all clinicians are more successful with a videolaryngoscope. We will compare whether clinicians who are randomly assigned to intubate newborn infants using a videolaryngoscope are more successful in intubating newborn infants at the first attempt compared to clinicians who are randomly assigned to intubate newborn infants using a standard laryngoscope.

The investigators will study newborn infants who are undergoing intubation at the discretion of their treating clinicians in delivery room or in the Neonatal Intensive Care Unit (NICU).Term and preterm infants of any gender will be eligible to participate. Babies with upper airway anomalies will be ineligible. Participants will be randomly assigned in a 1:1 ratio to "VIDEO" or ""STANDARD" group. Intubation success will be determined in both groups using an exhaled carbon dioxide detector or flow sensor. Caregivers and outcome assessors will not be masked to group assignment. The investigators will enrol 214 babies to the study.

Conditions

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Intubation, Intratracheal Infant, Newborn Laryngoscopes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group, randomised clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Videolaryngoscope

Intubation attempted with C-MAC videolaryngoscope

Group Type EXPERIMENTAL

Videolaryngoscopy

Intervention Type DEVICE

Indirect laryngoscopy using the C-MAC videolaryngoscope

Standard laryngoscope

Intubation attempted with standard laryngoscope

Group Type ACTIVE_COMPARATOR

Direct laryngoscopy

Intervention Type DEVICE

Direct laryngoscopy with a standard laryngoscope

Interventions

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Videolaryngoscopy

Indirect laryngoscopy using the C-MAC videolaryngoscope

Intervention Type DEVICE

Direct laryngoscopy

Direct laryngoscopy with a standard laryngoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Newborn infants (term and preterm, of any gender) in whom endotracheal intubation is attempted in the course of their clinical care in the Delivery Room or Neonatal Intensive Care Unit.