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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorUniversity College Dublin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Just-in-time video training

    Other intervention

    A "Just-in-time" educational video was designed and produced by the investigating team. Content of the video includes; * Environmental set up and patient positioning * Equipment preparation including stylet insertion * Description of internal anatomy of airway * Suggested instructional language for supervisors * Example footage of an intubation * Tips and common pitfalls * Guidance for intubation assistant on how to perform "cricoid" pressure

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Just-in-Time InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Total laryngoscopy time in seconds

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.

Time frame
24 months

Secondary outcomes

1

Number of intubation attempts

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

Time frame
24 months
2

Duration of each attempt

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.

Time frame
24 months
3

Lowest heart rate during attempt

Lowest heart rate measured on bedside monitor during intubation attempt (defined above)

Time frame
24 months
4

Lowest oxygen saturation during attempt

Lowest oxygen saturation measured measured on bedside monitor during intubation attempt (defined above)

Time frame
24 months

Other outcomes

Sponsors and contacts

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University College Dublin

Lead sponsor

National Maternity Hospital, Ireland

Collaborator

This trial is not recruiting at the moment. You can still explore other options: