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Clinical Trials/NCT04994652
NCT04994652
Completed
Not Applicable

A Randomised Trial of Videolaryngoscopy Or Direct Laryngoscopy for Endotracheal Intubation in Newborn Infants

University College Dublin1 site in 1 country214 target enrollmentSeptember 4, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation, Intratracheal
Sponsor
University College Dublin
Enrollment
214
Locations
1
Primary Endpoint
Intubation success at first attempt
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 4, 2021
End Date
November 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • Infants with upper airway anomalies

Outcomes

Primary Outcomes

Intubation success at first attempt

Time Frame: 5 minutes

Endotracheal intubation at first attempt confirmed with an exhaled carbon dioxide detector or flow sensor

Secondary Outcomes

  • Number of attempts taken to intubate successfully(30 minutes)
  • Duration of successful attempt(30 minutes)
  • Lowest SpO2 during first intubation attempt(5 minutes)
  • Correct ETT tip position on CXR(1 hour)
  • Lowest HR during first intubation attempt(5 minutes)
  • Crossover to alternative device(30 minutes)

Study Sites (1)

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