A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants

Many newborn infants have breathing difficulty after birth, particularly when they are born prematurely. Many of these infants are supported with nasal continuous positive airway pressure (NCPAP). Some of the infants deteriorate despite treatment with NCPAP and have a thin catheter inserted into their trachea for the administration of surfactant, which is then immediately removed (often referred to as "less-invasive surfactant administration" or LISA). Insertion of a thin catheter is usually performed by doctors who are experienced at intubation (i.e. inserting endotracheal tubes, ETTs). They look directly into the the infants mouth using a standard laryngoscope to identify the opening of the airway (i.e. perform direct laryngoscopy). More recently video laryngoscopes have been developed. These devices display a magnified image of the airway on a screen that can be viewed indirectly by the doctor attempting to insert the ETT or thin catheter, and also by others. A single centre study reported that more infants were successfully intubated at the first attempt when doctors performed indirect video laryngoscopy compared to direct laryngoscopy.

It is possible to independently verify when a doctor has correctly inserted and ETT, for example by detecting carbon dioxide coming out of the tube or seeing condensation in the tube during exhalation, or by hearing breath sounds by listening to the chest during positive pressure inflations. It is not possible to independently verify whether a doctor has correctly inserted a thin catheter under direct laryngoscopy, by these or other means. The standard (and to date only) way of confirming that a thin catheter has been correctly inserted is to rely on the report of the operator. Video laryngoscopy, in contrast, allows the independent verification of the tip of a thin catheter by one or more people observing the screen.

The investigators are performing NEU-VODE, a stepped wedge cluster randomised study of the introduction of video laryngoscopy versus direct laryngoscopy for the intubation of newborn infants. Alongside this study, the investigators are performing a study of infants who have a thin endotracheal catheter inserted under video laryngoscopy versus direct laryngoscopy. As it is not possible to measure the outcome of successful insertion of the thin catheter equally in both groups, this is a prospective observational cohort study. The investigators will record information on infants who have a thin catheter inserted into the trachea for the purpose of surfactant administration at centres participating in the NEU-VODE study. The type of laryngoscope used for thin catheter insertion attempts will not be mandated; instead, the investigators will compare the information of groups within the cohort who have their first attempt made using the video laryngoscope to the group who have their first attempt made with direct laryngoscopy.

• Successful thin catheter insertion at the first attempt [Срок оценки: At 30 minutes from the start of the insertion attempt]
• Physiologic instability during first thin endotracheal catheter insertion attempt [Срок оценки: At 30 minutes from the start of the insertion attempt]
• Duration of laryngoscopy of first insertion attempt [Срок оценки: At 30 minutes from the start of the insertion attempt]
• Number of attempts taken to insert thin endotracheal catheter [Срок оценки: At 30 minutes from the start of the insertion attempt]
• Time taken to insert thin endotracheal catheter on successful attempt [Срок оценки: At 30 minutes from the start of the insertion attempt]
• Total laryngoscopy time to successful insertion [Срок оценки: At 30 minutes from the start of the insertion attempt]
• Lowest oxygen saturation (SpO2) during the procedure [Срок оценки: At 30 minutes from the start of the insertion attempt]
• Lowest heart rate (HR) during the procedure [Срок оценки: At 30 minutes from the start of the insertion attempt]
• Oral trauma [Срок оценки: At 1 hour from the start of the insertion attempt]
• Chest compressions [Срок оценки: At 1 hour from the start of the insertion attempt]
• Adrenaline [Срок оценки: At 1 hour from the start of the insertion attempt]
• Further thin catheter surfactant treatment [Срок оценки: Within 72 hours of insertion attempt]