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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-28
SponsorUniversity College Dublin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

no parental consent provided to share their data

Trial 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Video laryngoscopy used to insert thin endotracheal catheter

    Device

    Video laryngoscopy used to insert thin endotracheal catheter

  • Direct laryngoscopy used to insert thin endotracheal catheter

    Device

    Direct laryngoscopy used to insert thin endotracheal catheter

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Video laryngoscopy used to insert thin endotracheal catheter1 intervention
Group B: Direct laryngoscopy used to insert thin endotracheal catheter1 intervention

Trial outcomes

Primary outcomes

1

Successful thin catheter insertion at the first attempt without physiologic instability

Successful thin catheter insertion at the first attempt without fall in SpO2 \>20% from baseline or HR\<100bpm

Time frame
At 30 minutes from the start of the insertion attempt

Secondary outcomes

1

Successful thin catheter insertion at the first attempt

Successful thin catheter insertion at the first attempt

Time frame
At 30 minutes from the start of the insertion attempt
2

Physiologic instability during first thin endotracheal catheter insertion attempt

Fall in SpO2\>20% from baseline or HR\<100bpm during first thin endotracheal catheter insertion attempt

Time frame
At 30 minutes from the start of the insertion attempt
3

Duration of laryngoscopy of first insertion attempt

Interval from introduction of laryngoscopy blade to its removal (seconds)

Time frame
At 30 minutes from the start of the insertion attempt
4

Number of attempts taken to insert thin endotracheal catheter

Number of attempts taken to insert thin endotracheal catheter

Time frame
At 30 minutes from the start of the insertion attempt

Other outcomes

Sponsors and contacts

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University College Dublin

Lead sponsor

Leiden University Medical Center

Collaborator