Many newborn babies have difficulty breathing. When babies need a lot of help, a doctor will intubate them - i.e. put a tube into their windpipe (trachea) - so that they can be given support with a breathing machine. Intubation is a difficult procedure, during which many babies have falls in their blood oxygen levels and heart rate. When doctors intubate babies, they use a device called a laryngoscope to identify the entrance to the windpipe. A standard laryngoscope has a light at its tip. When doctors use this device, they insert it into the baby's mouth and then look directly into the mouth to find the entrance (direct laryngoscopy). Less than half of first attempts to insert a tube are successful using this device. More recently, video laryngoscopes have been developed. These devices also have a camera at the tip and display a magnified view of the entrance to the windpipe on a screen. A study at one hospital showed that the doctors there inserted the tube at the first attempt more often when they used a video laryngoscope instead of a standard laryngoscope. This study was not large enough to see whether fewer babies had low oxygen levels or heart rate during the procedure.
The goal of this clinical trial is to see whether more newborn babies are intubated at the first attempt without falls in their blood oxygen levels or heart rate when the doctors use video laryngoscopy compared to direct laryngoscopy.
Hospitals where doctors routinely intubate babies by looking directly into the mouth will take part in the NEU-VODE study. From the start of the study, the doctors at each hospital will continue with their usual approach to intubation and collect information about intubation attempts. As the study progresses, the doctors at each participating hospital will switch one--by-one to routinely attempting intubation with a video laryngoscope. The date on which they switch will be determined by chance. By the end of the study, each hospital will have had a study period where babies were routinely intubated using direct laryngoscopy and video laryngoscopy.
At the end of the study, the information collected from all the babies intubated during the study will be compared to see if more babies were successfully intubated at the first attempt without falls in their blood oxygen levels or heart rate in the video laryngoscopy group.
Infants of any gestational age in whom endotracheal intubation is attempted can be included in this study once there is parental consent to the use their infant's data.
Infants will be excluded if parents do not consent for their infants' data to be used.
Parallel
Video laryngoscopy
DeviceVideo laryngoscopy with C-MAC (Karl Storz, Tuttlingen, Germany)
Direct laryngoscopy with standard laryngoscope
DeviceDirect laryngoscopy with standard laryngoscope
Successful intubation at the first attempt without physiologic instability
Successful intubation at the first attempt without physiologic instability where: 1. an intubation attempt is defined as the introduction of the laryngoscope blade into the mouth, whether or not an attempt is made to pass an endotracheal tube (ETT); 2. success is determined by detection of exhaled carbon dioxide (CO2) or with clinical signs (auscultation of breath sounds, condensation in the ETT); 3. physiologic instability is defined as a fall in oxygen saturation (SpO2) of \> 20% from the pre-attempt value or heart rate (HR) \< 100 beats per minute (bpm) during the attempt
Successful intubation at the first attempt
Successful intubation at the first attempt where: 1. an intubation attempt is defined as introduction of the laryngoscope blade into the mouth, whether or not an attempt is made to pass an ETT; 2. success is determined with exhaled CO2 or clinical signs (auscultation of breath sounds, condensation in the ETT)
Physiologic instability during the first intubation attempt
Fall in SpO2 \> 20% from the pre-attempt value or HR \< 100bpm during the first intubation attempt
Lowest SpO2 (%) measured with pulse oximetry during the procedure
Lowest oxygen saturation SpO2 (%) measured with pulse oximetry during the procedure
Lowest heart rate (HR) during the procedure
Lowest heart rate (HR) during the procedure
Click on the lead sponsor to view all of their trials.
University College Dublin
Lead sponsor
National Maternity Hospital, Ireland
Collaborator
Leiden University Medical Center
Collaborator
