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Completed

NCT Number: NCT04994652

Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns

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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Key information

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Maternity Hospital

Dublin, Co. Dublin, D02 YH21, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

videolaryngoscopy

Device

Indirect laryngoscopy using the C-MAC videolaryngoscope

direct laryngoscopy

Device

Direct laryngoscopy with a standard laryngoscope

Primary outcomes

  1. 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

  1. Lowest SpO2 during first intubation attempt

    Time frame: 5 minutes

    Lowest oxygen saturation recorded during first intubation attempt

  2. Lowest HR during first intubation attempt

    Time frame: 5 minutes

    Lowest heart rate during first intubation during first intubation attempt

  3. Number of attempts taken to intubate successfully

    Time frame: 30 minutes

    Number of attempts taken to successfully intubate the infant

  4. Duration of successful attempt

    Time frame: 30 minutes

    Interval measured in seconds from the introduction of the laryngosocpe blade into the infants mouth to its removal in the successful intubation attempt

  5. Crossover to alternative device

    Time frame: 30 minutes

    Use of alternative non-assigned laryngosocpe to attempt intubation

  6. Correct ETT tip position on CXR

    Time frame: 1 hour

    Correct endotracheal tube tip position (i.e. between upper border of first thoracic vertebra and lower border of second thoracic vertebra) on chest radiograph

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study title

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

Acronym: VODE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2021
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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