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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
214
Indirect laryngoscopy using the C-MAC videolaryngoscope
Direct laryngoscopy with a standard laryngoscope
National Maternity Hospital
Dublin, Co. Dublin, Ireland
Intubation success at first attempt
Endotracheal intubation at first attempt confirmed with an exhaled carbon dioxide detector or flow sensor
Time frame: 5 minutes
Lowest SpO2 during first intubation attempt
Lowest oxygen saturation recorded during first intubation attempt
Time frame: 5 minutes
Lowest HR during first intubation attempt
Lowest heart rate during first intubation during first intubation attempt
Time frame: 5 minutes
Number of attempts taken to intubate successfully
Number of attempts taken to successfully intubate the infant
Time frame: 30 minutes
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
Time frame: 30 minutes
Crossover to alternative device
Use of alternative non-assigned laryngosocpe to attempt intubation
Time frame: 30 minutes
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
Time frame: 1 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.