Clinical trial NCT06758492: A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants
Official title: A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Distress Syndrome (Neonatal)
Respiratory Distress Syndrome (RDS)
Video Laryngoscopy
Surfactant
Keywords: infant, newborn
respiratory distress syndrome
surfactant
video laryngoscopy
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2025-01-03
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants (\<28 days old) who have a thin catheter inserted into their trachea for the purpose of surfactant administration ("less-invasive surfactant administration", LISA)

Brief summary: Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Some of the babies who are given surfactant get it through a ventilation tube (endotracheal tube, ETT), while others get it through a thin catheter that is too small for ventilation. When doctors insert a tube or a thin catheter into the windpipe of a baby, they use an instrument called a laryngoscope, which has a light at its tip, to identify the entrance. Most often doctors look directly into the baby's mouth with a standard laryngoscope to identify the entrance to the windpipe. However, newer video laryngoscopes have a camera along with the light at their tip, which displays a picture of the entrance to the windpipe on a screen. In a study performed at one hospital, doctors inserted an ETT first time more often when they used a video laryngoscope.

The investigators are doing a study at many hospitals where doctors usually use a standard laryngoscope to insert tubes and thin catheters into a baby's trachea by looking directly into the mouth. Each hospital will switch one-by-one to using a video laryngoscope when inserting a tube. The investigators will compare the information we collect to see if more babies who have a tube inserted first time without falls in their oxygen levels or heart rate with a video laryngoscope. The investigators will also collect information on babies who have a thin catheter inserted to compare whether doctors use fewer attempts when they use a video laryngoscope.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* newborn infants of any sex who are are having a thin catheter inserted into their trachea for the purpose of surfactant administration

Exclusion Criteria:

* no parental consent provided to share their data

Primary outcomes:
measure: Successful thin catheter insertion at the first attempt without physiologic instability
timeFrame: At 30 minutes from the start of the insertion attempt
Secondary outcomes:
measure: Successful thin catheter insertion at the first attempt
timeFrame: At 30 minutes from the start of the insertion attempt
measure: Physiologic instability during first thin endotracheal catheter insertion attempt
timeFrame: At 30 minutes from the start of the insertion attempt
measure: Duration of laryngoscopy of first insertion attempt
timeFrame: At 30 minutes from the start of the insertion attempt
measure: Number of attempts taken to insert thin endotracheal catheter
timeFrame: At 30 minutes from the start of the insertion attempt
measure: Time taken to insert thin endotracheal catheter on successful attempt
timeFrame: At 30 minutes from the start of the insertion attempt
measure: Total laryngoscopy time to successful insertion
timeFrame: At 30 minutes from the start of the insertion attempt
measure: Lowest oxygen saturation (SpO2) during the procedure
timeFrame: At 30 minutes from the start of the insertion attempt
measure: Lowest heart rate (HR) during the procedure
timeFrame: At 30 minutes from the start of the insertion attempt
measure: Oral trauma
timeFrame: At 1 hour from the start of the insertion attempt
measure: Chest compressions
timeFrame: At 1 hour from the start of the insertion attempt
measure: Adrenaline
timeFrame: At 1 hour from the start of the insertion attempt
measure: Further thin catheter surfactant treatment
timeFrame: Within 72 hours of insertion attempt
measure: Endotracheal intubation and ventilation
timeFrame: Within 72 hours of insertion attempt
measure: Surfactant treatment via endotracheal tube
timeFrame: Within 72 hours of insertion attempt
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre
city: Zagreb
country: Croatia
facility: Clinical Hospital "Holy Spirit"
city: Brno
country: Czech Republic
facility: University Hospital Brno
city: Prague
country: Czech Republic
facility: General University Hospital
city: Prague
country: Czech Republic
facility: Institute for Mother and Child Care
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
city: Budapest
country: Hungary
facility: Second Semmelweiss University
city: Padova
country: Italy
facility: University of Padova
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Poznań
country: Poland
facility: Poznań University of Medical Sciences
city: Rzeszow
country: Poland
facility: Provincial Hospital No. 2
city: Sibiu
country: Romania
facility: Clinical County Emergency Hospital
city: Targu Mures
country: Romania
facility: George Emil Palade University
city: Valencia
country: Spain
facility: University and Polytechnic Hospital La Fe
Study officials:
affiliation: National Maternity Hospital, Dublin, Ireland
name: Colm P.F. O'Donnell, MB PhD
role: PRINCIPAL_INVESTIGATOR
References: