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Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04994652
Acronym
VODE
Enrollment
214
Registered
2021-08-06
Start date
2021-09-04
Completion date
2023-11-20
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn, Intubation, Intratracheal, Laryngoscopes

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.

Interventions

DEVICEVideolaryngoscopy

Indirect laryngoscopy using the C-MAC videolaryngoscope

DEVICEDirect laryngoscopy

Direct laryngoscopy with a standard laryngoscope

Sponsors

University College Dublin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Parallel group, randomised clinical trial

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intubation success at first attempt5 minutesEndotracheal intubation at first attempt confirmed with an exhaled carbon dioxide detector or flow sensor

Secondary

MeasureTime frameDescription
Lowest HR during first intubation attempt5 minutesLowest heart rate during first intubation during first intubation attempt
Number of attempts taken to intubate successfully30 minutesNumber of attempts taken to successfully intubate the infant
Lowest SpO2 during first intubation attempt5 minutesLowest oxygen saturation recorded during first intubation attempt
Crossover to alternative device30 minutesUse of alternative non-assigned laryngosocpe to attempt intubation
Correct ETT tip position on CXR1 hourCorrect endotracheal tube tip position (i.e. between upper border of first thoracic vertebra and lower border of second thoracic vertebra) on chest radiograph
Duration of successful attempt30 minutesInterval measured in seconds from the introduction of the laryngosocpe blade into the infants mouth to its removal in the successful intubation attempt

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026