Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns

Not Applicable

Completed

• Conditions: Infant, Newborn; Laryngoscopes; Intubation, Intratracheal
• Interventions: Device: Direct laryngoscopy; Device: Videolaryngoscopy

• Registration Number: NCT04994652
• Lead Sponsor: University College Dublin

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.

Study Timeline

• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-06
• Study Start: 2021-09-04
• Status Verified: 2023-11
• Primary Completion: 2023-11-17
• Study Completion: 2023-11-20
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard laryngoscope	Direct laryngoscopy	Intubation attempted with standard laryngoscope
Videolaryngoscope	Videolaryngoscopy	Intubation attempted with C-MAC videolaryngoscope

Primary Outcome Measures

Name	Time	Method
Intubation success at first attempt	5 minutes	Endotracheal intubation at first attempt confirmed with an exhaled carbon dioxide detector or flow sensor

Secondary Outcome Measures

Name	Time	Method
Number of attempts taken to intubate successfully	30 minutes	Number of attempts taken to successfully intubate the infant
Duration of successful attempt	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
Lowest SpO2 during first intubation attempt	5 minutes	Lowest oxygen saturation recorded during first intubation attempt
Correct ETT tip position on CXR	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
Lowest HR during first intubation attempt	5 minutes	Lowest heart rate during first intubation during first intubation attempt
Crossover to alternative device	30 minutes	Use of alternative non-assigned laryngosocpe to attempt intubation

Trial Locations

Locations (1)

National Maternity Hospital; 🇮🇪 Dublin, Co. Dublin, Ireland