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

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.

Study Overview

• Status: Recruiting
• Conditions: Surfactant; Respiratory Distress Syndrome (RDS); Respiratory Distress Syndrome (Neonatal); Video Laryngoscopy
• Intervention / Treatment: Device: Video laryngoscopy used to insert thin endotracheal catheter; Device: Direct laryngoscopy used to insert thin endotracheal catheter

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Colm P.F. O'Donnell, MB PhD; Phone Number: +35316373100; Email: codonnell@nmh.ie
• Study Contact Backup: Name: Janneke Dekker, PhD; Email: j.dekker@lumc.nl

Study Locations

• Croatia
  • Rijeka, Croatia
    • Recruiting
    • Clinical Hospital Centre
    • Contact: Iva Bilić Čače, MD PhD
  • Zagreb, Croatia
    • Recruiting
    • Clinical Hospital "Holy Spirit"
    • Contact: Rebeka Ribičić, MD
• Czech Republic
  • Brno, Czech Republic
    • Recruiting
    • University Hospital Brno
    • Contact: Andrea Staníková, MD
  • Prague, Czech Republic
    • Recruiting
    • General University Hospital
    • Contact: Tereza Lamberská, MD PhD
  • Prague, Czech Republic
    • Recruiting
    • Institute for Mother and Child Care
    • Contact: Milena Tušková, MD
• Greece
  • Thessaloniki, Greece
    • Recruiting
    • Aristotle University of Thessaloniki
    • Contact: Kosmas Sarafidis, MD
• Hungary
  • Budapest, Hungary
    • Not yet recruiting
    • Second Semmelweiss University
    • Contact: Zsuzsanna Nagy, MD
• Italy
  • Padova, Italy
    • Not yet recruiting
    • University of Padova
    • Contact: Daniele Trevisanuto, MD PhD
• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Anne Lee Solevåg, MD PhD
• Poland
  • Gdańsk, Poland
    • Recruiting
    • Medical University of Gdansk
    • Contact: Joanna Jassem-Bobowicz, MD
  • Katowice, Poland
    • Recruiting
    • Medical University of Silesia
    • Contact: Iwona Chudek Maruniak, MD
  • Poznań, Poland
    • Recruiting
    • Poznan University of Medical Sciences
    • Contact: Tomasz Szczapa, MD PhD
  • Rzeszow, Poland
    • Recruiting
    • Provincial Hospital No. 2
    • Contact: Witold Blaz, MD
• Romania
  • Sibiu, Romania
    • Recruiting
    • Clinical County Emergency Hospital
    • Contact: Maria Livia Ognean, MD PhD
  • Targu Mures, Romania
    • Recruiting
    • George Emil Palade University
    • Contact: Manuela Curcerea, MD PhD
• Spain
  • Valencia, Spain
    • Recruiting
    • University and Polytechnic Hospital La Fe
    • Contact: Raquel Escrig Fernández, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Video laryngoscopy used to insert thin endotracheal catheter	Device: Video laryngoscopy used to insert thin endotracheal catheter; 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; Direct laryngoscopy used to insert thin endotracheal catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 30 minutes from the start of the insertion attempt

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful thin catheter insertion at the first attempt	Successful thin catheter insertion at the first attempt	At 30 minutes from the start of the insertion attempt
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	At 30 minutes from the start of the insertion attempt
Duration of laryngoscopy of first insertion attempt	Interval from introduction of laryngoscopy blade to its removal (seconds)	At 30 minutes from the start of the insertion attempt
Number of attempts taken to insert thin endotracheal catheter	Number of attempts taken to insert thin endotracheal catheter	At 30 minutes from the start of the insertion attempt
Time taken to insert thin endotracheal catheter on successful attempt	Interval from insertion of laryngoscope blade to insertion of thin endotracheal catheter on successful attempt (seconds)	At 30 minutes from the start of the insertion attempt
Total laryngoscopy time to successful insertion	Sum of all intervals from introduction of laryngoscope blade to removal for unsuccessful insertion attempts; plus interval from introduction of blade to catheter insertion for successful attempt in seconds	At 30 minutes from the start of the insertion attempt
Lowest oxygen saturation (SpO2) during the procedure	Lowest oxygen saturation (SpO2) during the procedure	At 30 minutes from the start of the insertion attempt
Lowest heart rate (HR) during the procedure	Lowest heart rate (HR) during the procedure	At 30 minutes from the start of the insertion attempt
Oral trauma	Oral trauma reported by clinicians	At 1 hour from the start of the insertion attempt
Chest compressions	Chest compressions	At 1 hour from the start of the insertion attempt
Adrenaline	Adrenaline	At 1 hour from the start of the insertion attempt
Further thin catheter surfactant treatment	Further thin catheter surfactant treatment	Within 72 hours of insertion attempt
Endotracheal intubation and ventilation	Endotracheal intubation and ventilation	Within 72 hours of insertion attempt
Surfactant treatment via endotracheal tube	Surfactant treatment via endotracheal tube	Within 72 hours of insertion attempt

Collaborators and Investigators

• Sponsor: University College Dublin
• Collaborators: Leiden University Medical Center
• Investigators: Principal Investigator: Colm P.F. O'Donnell, MB PhD, National Maternity Hospital, Dublin, Ireland

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): December 13, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: video laryngoscopy; respiratory distress syndrome; surfactant; infant, newborn
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: NEU-VODEtec 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared o consideration of reasonable request to investigators
• IPD Sharing Time Frame: Study publication, for 2 years

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No