Clinical trial NCT06898801: An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.
Official title: Neonatal INtubation After "Just-in-time" Audiovisual Training: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Endotracheal Intubation
Neonatal Intubation Performance
Prematurity
Neonate
Education, Medical
Keywords: Just-in-Time
Neonatal intubation
Teaching
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: National Maternity Hospital, Ireland
First posted: 2025-03-27
Enrollment: 140
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Shortly before an intubation, a neonate for intubation will be randomised in 1:1 ratio to "Just-in-Time" intervention or none. Randomisation will be stratified by gestational age category: \<32 week gestational age (GA) or \>32 weeks GA. Allocations will be in sealed opaque envelopes in random order according to gestational age strata. Allocation envelopes will be stored in a dedicated box in the Neonatal Intensive Care Unit (NICU). One randomisation will be carried out for each intubation encounter regardless of number of attempts. Each baby will only be included in the study once. The intubator and team will not be blinded to group assignment as masking will not be possible. Investigators will not be blinded. Outcome assessors will be blinded to the randomisation group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. When a baby has serious breathing difficulty, inserting a breathing tube to place them on a ventilator can be lifesaving. A breathing tube must be placed through the vocal cords into the windpipe (trachea). A device called a laryngoscope is placed in a patients mouth to allow the doctor to see the vocal cords and insert the tube correctly.

The skill of placing this breathing tube (intubation) is important for doctors and specialists to learn so that they can confidently perform it in an emergency.

In the past, doctors had more opportunities during their training to learn and practice this with supervision from seniors. In recent years, babies, thankfully, need to be intubated less frequently and doctors working hours are better regulated. As a result, junior doctors have less chances to perform this skill. There is a need to improve how we teach the procedure of intubating babies to doctors in training to meet the needs of trainees today.

The investigators want to perform a study to help teach doctors in training how to perform intubation of a newborn using a video laryngoscope. The team are looking to assess if showing a short educational video to the doctor and team just before performing an intubation using a video laryngoscope will reduce the time the procedure takes. This is called a "Just-in-Time" video. The investigators aim to demonstrate a benefit by performing a randomised control trial. This means that when a baby requires intubation as decided by their treating doctors, the team will be randomly allocated to view a "Just-in-Time" video before performing the intubation or not. The investigators will then compare the two groups to see if there is a difference in the total time the procedure takes.

Detailed description: Performing an urgent intubation on a critically ill newborn can be stressful and daunting. It is a vital, life-saving skill for not only neonatologists but paediatricians who may be faced with the rare scenario of an unwell newborn in respiratory distress. Neonatal intubation remains a mandatory competency of the higher speciality training scheme in General Paediatrics ( Royal College of Physicians of Ireland.) This is in line with paediatric training in the UK and Europe and neonatal intubation competency remains a concern not only in Ireland but worldwide. Teaching neonatal intubation via an apprenticeship model needs to be balanced with the need to minimise risk to babies of prolonged or repeated attempts. Paediatric and neonatal trainees can struggle to achieve competency in this skill as advances in perinatal care such as non-invasive ventilation, less invasive surfactant methods and avoidance of universal intubation for meconium have decreased the number of routine intubations performed. With greater numbers of doctors and advanced neonatal nurse practitioners and fewer working hours, the number of intubation opportunities for trainees continues to fall. Even for more experienced practitioners it can be challenging to maintain intubation competency.

The teaching of skills to paediatricians and neonatologists needs to adapt to the changing nature of training. "Just-in-Time" (JiT) educational interventions have been studied in a variety of simulated and clinical environments to improve training or increase success of uncommonly performed procedures by providing a brief educational intervention shortly before performing the procedure . A study by Gizicki et al applied this concept to neonatal intubation in the clinical setting. They randomised 65 residents performing intubation to receive a Just-in-Time manikin based low fidelity simulation session or a 5-minute video just before performing an intubation. They did not demonstrate a difference in overall intubation success rates between these groups although intubation success rates in both groups were higher than baseline. Intubation in this study was performed using both direct and video laryngoscopy. It has been demonstrated that video laryngoscopy (VL) improves neonatal intubation success, but the method of intubation differs from standard laryngoscopy and there is a learning curve for operators using this device initially. Given that video laryngoscopic intubation is likely to become the standard of care, there is a need to train operators to use this device correctly in order to benefit from its greater utility.

A recent study performed in the National Maternity Hospital by Ni Chathasaigh et al examined video recordings of neonatal intubations using VL. The VAN (Video laryngoscopic Analysis of Neonatal Intubations) study recorded the external environment in addition to the internal VL views of the baby's airway. Analysis of these videos highlights common features of successful and unsuccessful attempts. Using the lessons from the VAN study, the investigators propose a study of a novel "Just-in-Time" educational video to improve intubation performance by reducing the total time required from insertion of the laryngoscope to successful intubation. The "Just-in-Time" video will supplement an intubation checklist and will concentrate on the key aspects of intubation; anatomy, intubator position, cricoid pressure, laryngoscopic technique and supervisor instructions. The "Just-in-Time" video will be directed at the intubator, supervisor and assisting nurse.

Eligibility criteria: Inclusion Criteria:

Neonates of any age or gestation who require endotracheal intubation in the Neonatal Intensive Care Unit in the National Maternity Hospital during the study period.

Exclusion Criteria:

* Neonates with an upper airway malformation.
* If it is deemed by the treating clinical team that the clinical scenario does not allow time for the intervention e.g. cardiac arrest

Primary outcomes:
measure: Total laryngoscopy time in seconds
timeFrame: 24 months
Secondary outcomes:
measure: Number of intubation attempts
timeFrame: 24 months
measure: Duration of each attempt
timeFrame: 24 months
measure: Lowest heart rate during attempt
timeFrame: 24 months
measure: Lowest oxygen saturation during attempt
timeFrame: 24 months
measure: Chest compressions during procedure
timeFrame: 24 months
measure: Adrenaline administration during procedure
timeFrame: 24 months
measure: Oral trauma
timeFrame: 24 months
measure: Crossover to alternative operator
timeFrame: 24 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Department of Neonatology, The National Maternity Hospital
Study officials:
affiliation: Department of Neonatology, National Maternity Hospital. University College Dublin
name: Anna E Curley
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neonatology, National Maternity Hospital. University College Dublin
name: Eoin O'Currain
role: PRINCIPAL_INVESTIGATOR
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