An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.

Not Applicable

Not yet recruiting

• Conditions: Respiratory Distress Syndrome, Newborn; Endotracheal Intubation; Neonatal Intubation Performance; Prematurity; Neonate; Education, Medical

• Registration Number: NCT06898801
• Lead Sponsor: University College Dublin

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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Primary Completion: 2027-03
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total laryngoscopy time in seconds	24 months	An intubation attempt is defined as the introduction of the laryngoscope blade into the mouth with the intention of inserting an endotracheal tube (ETT), regardless of whether an ETT was inserted. Laryngoscopy time is the time from insertion of the laryngoscope blade into the mouth during an intubation attempt until removal of the blade, regardless of whether an ETT was successfully inserted. Total laryngoscopy time is defined as the cumulative duration of laryngoscopy time of all intubation attempts undertaken until ETT is inserted and confirmed by exhaled carbon dioxide detection or the procedure is abandoned.

Secondary Outcome Measures

Name	Time	Method
Lowest heart rate during attempt	24 months	Lowest heart rate measured on bedside monitor during intubation attempt (defined above)
Number of intubation attempts	24 months	The number of times the laryngoscope blade is inserted into the mouth with the intention of inserting an endotracheal tube (ETT), regardless of whether an ETT was inserted in one encounter until correct placement of ETT tube, confirmed by exhaled carbon dioxide detection, or procedure abandoned
Duration of each attempt	24 months	Duration in seconds of each intubation attempt in an encounter defined as insertion of laryngoscope into the mouth with the intention of inserting an endotracheal tube (ETT), regardless of whether an ETT was inserted.
Lowest oxygen saturation during attempt	24 months	Lowest oxygen saturation measured measured on bedside monitor during intubation attempt (defined above)
Chest compressions during procedure	24 months	If chest compressions are required during the intubation
Adrenaline administration during procedure	24 months	If bolus adrenaline administration is required during intubation procedure
Oral trauma	24 months	If oral trauma is sustained during an intubation
Crossover to alternative operator	24 months	Where there are multiple intubation attempts in an encounter, if the practitioner performing intubation is substituted for another for one or more of the attempts

Trial Locations

Locations (1)

Department of Neonatology, The National Maternity Hospital; 🇮🇪 Dublin, Ireland