Clinical trial NCT04994652: Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns
Official title: A Randomised Trial of Videolaryngoscopy Or Direct Laryngoscopy for Endotracheal Intubation in Newborn Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Intratracheal
Infant, Newborn
Laryngoscopes
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 214
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, randomised clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intubation success at first attempt
timeFrame: 5 minutes
Secondary outcomes:
measure: Lowest SpO2 during first intubation attempt
timeFrame: 5 minutes
measure: Lowest HR during first intubation attempt
timeFrame: 5 minutes
measure: Number of attempts taken to intubate successfully
timeFrame: 30 minutes
measure: Duration of successful attempt
timeFrame: 30 minutes
measure: Crossover to alternative device
timeFrame: 30 minutes
measure: Correct ETT tip position on CXR
timeFrame: 1 hour
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: National Maternity Hospital
state: Co. Dublin
Study officials:
References: