Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns

Infant, Newborn Clinical Trial

— VODE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994652
• Other study ID #: VODE01
• Status: Completed
• Phase: N/A
• Start date: September 4, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: November 2023
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: November 20, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant, Newborn
• Intubation, Intratracheal
• Laryngoscopes

Intervention

Device:
• Videolaryngoscopy
Indirect laryngoscopy using the C-MAC videolaryngoscope
• Direct laryngoscopy
Direct laryngoscopy with a standard laryngoscope

Locations

Country	Name	City	State
Ireland	National Maternity Hospital	Dublin	Co. Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation success at first attempt	Endotracheal intubation at first attempt confirmed with an exhaled carbon dioxide detector or flow sensor	5 minutes
Secondary	Lowest SpO2 during first intubation attempt	Lowest oxygen saturation recorded during first intubation attempt	5 minutes
Secondary	Lowest HR during first intubation attempt	Lowest heart rate during first intubation during first intubation attempt	5 minutes
Secondary	Number of attempts taken to intubate successfully	Number of attempts taken to successfully intubate the infant	30 minutes
Secondary	Duration of successful attempt	Interval measured in seconds from the introduction of the laryngosocpe blade into the infants mouth to its removal in the successful intubation attempt	30 minutes
Secondary	Crossover to alternative device	Use of alternative non-assigned laryngosocpe to attempt intubation	30 minutes
Secondary	Correct ETT tip position on CXR	Correct endotracheal tube tip position (i.e. between upper border of first thoracic vertebra and lower border of second thoracic vertebra) on chest radiograph	1 hour