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

NCT06898801 | Not Yet Recruiting

• 1 other identifier: EC44.2024
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Just-in-Time; Neonatal intubation; Teaching

Outcome Measures

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.

  24 months

Secondary Outcomes (8)

• Number of intubation attempts

  24 months

• Duration of each attempt

  24 months

• Lowest heart rate during attempt

  24 months

• Lowest oxygen saturation during attempt

  24 months

• Chest compressions during procedure

  24 months

Study Arms (2)

Just-in-Time Intervention

EXPERIMENTAL

The primary intubator, supervising clinician and intubation assistant or nurse will view the brief "Just-in-time" video once, immediately prior to performing the intubation with a video laryngoscope. The decision to intubate an infant and who will perform the intubation will be made by the clinical team. Other aspects of the procedure, for example premedications, use of pre-intubation checklist will not change from standard practice.

Other: Just-in-time video training

Control

NO INTERVENTION

Intubation will be carried out as per current standard practice with supervision of trainee by senior clinician or initial intubation by senior clinician.

Interventions

Just-in-time video training OTHER

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

Just-in-Time Intervention

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• National Maternity Hospital, Ireland: collaborator

Study Sites (1)

Department of Neonatology, The National Maternity Hospital

Dublin, D02 YH21, Ireland

Location

Related Publications (14)

• O'Keeffe AG, Ambler G, Barber JA. Sample size calculations based on a difference in medians for positively skewed outcomes in health care studies. BMC Med Res Methodol. 2017 Dec 2;17(1):157. doi: 10.1186/s12874-017-0426-1.

  PMID: 29197347 BACKGROUND

• Kothari R, Hodgson KA, Davis PG, Thio M, Manley BJ, O'Currain E. Time to desaturation in preterm infants undergoing endotracheal intubation. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):603-607. doi: 10.1136/archdischild-2020-319509. Epub 2021 Apr 30.

  PMID: 33931396 BACKGROUND

• Foran J, Moore CM, Ni Chathasaigh CM, Moore S, Purna JR, Curley A. Nasal high-flow therapy to Optimise Stability during Intubation: the NOSI pilot trial. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):244-249. doi: 10.1136/archdischild-2022-324649. Epub 2022 Oct 28.

  PMID: 36307187 BACKGROUND

• Ni Chathasaigh CM, Dunne EA, Geraghty LE, O'Donnell CPF, O'Currain E, Curley AE. Video analysis of neonatal intubations using video laryngoscopy: a prospective comparison of clinical practice with resuscitation guidelines. Arch Dis Child Fetal Neonatal Ed. 2025 Aug 19;110(5):479-484. doi: 10.1136/archdischild-2024-327723.

  PMID: 39832821 BACKGROUND

• O'Shea JE, Loganathan P, Thio M, Kamlin COF, Davis PG. Analysis of unsuccessful intubations in neonates using videolaryngoscopy recordings. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F408-F412. doi: 10.1136/archdischild-2017-313628. Epub 2017 Nov 10.

  PMID: 29127153 BACKGROUND

• Corder W, Nelin T, Ades AM, Flibotte J, Laverriere E, Daly Guris R, Soorikian L, Foglia EE. Association between video laryngoscopy characteristics and successful neonatal tracheal intubation: a prospective study. Arch Dis Child Fetal Neonatal Ed. 2024 Dec 20;110(1):91-95. doi: 10.1136/archdischild-2024-326992.

  PMID: 38951016 BACKGROUND

• Ni Chathasaigh CM, O'Currain E, Curley AE. Variations in newborn airway management. Ir Med J. 2023 May 18;116(5):776. No abstract available.

  PMID: 37555533 BACKGROUND

• Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.

  PMID: 37171122 BACKGROUND

• Riva T, Engelhardt T, Basciani R, Bonfiglio R, Cools E, Fuchs A, Garcia-Marcinkiewicz AG, Greif R, Habre W, Huber M, Petre MA, von Ungern-Sternberg BS, Sommerfield D, Theiler L, Disma N; OPTIMISE Collaboration. Direct versus video laryngoscopy with standard blades for neonatal and infant tracheal intubation with supplemental oxygen: a multicentre, non-inferiority, randomised controlled trial. Lancet Child Adolesc Health. 2023 Feb;7(2):101-111. doi: 10.1016/S2352-4642(22)00313-3. Epub 2022 Nov 24.

  PMID: 36436541 BACKGROUND

• Geraghty LE, Dunne EA, Ni Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5.

  PMID: 38709215 BACKGROUND

• Gizicki E, Assaad MA, Masse E, Belanger S, Olivier F, Moussa A. Just-In-Time Neonatal Endotracheal Intubation Simulation Training: A Randomized Controlled Trial. J Pediatr. 2023 Oct;261:113576. doi: 10.1016/j.jpeds.2023.113576. Epub 2023 Jun 21.

  PMID: 37353151 BACKGROUND

• McKay J, Wasserman M, Monuteaux MC, Hirsch AW, Nagler J. Just-in-time procedural training for pediatric emergency medicine trainees: A randomized educational interventional trial. AEM Educ Train. 2023 Jun 22;7(3):e10886. doi: 10.1002/aet2.10886. eCollection 2023 Jun.

  PMID: 37361189 BACKGROUND

• Braga MS, Tyler MD, Rhoads JM, Cacchio MP, Auerbach M, Nishisaki A, Larson RJ. Effect of just-in-time simulation training on provider performance and patient outcomes for clinical procedures: a systematic review. BMJ Simul Technol Enhanc Learn. 2015 Oct 5;1(3):94-102. doi: 10.1136/bmjstel-2015-000058. eCollection 2015.

  PMID: 35515199 BACKGROUND

• O'Shea JE, Scrivens A, Edwards G, Roehr CC. Safe emergency neonatal airway management: current challenges and potential approaches. Arch Dis Child Fetal Neonatal Ed. 2022 May;107(3):236-241. doi: 10.1136/archdischild-2020-319398. Epub 2021 Apr 21.

  PMID: 33883207 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anna E Curley

  Department of Neonatology, National Maternity Hospital. University College Dublin

  PRINCIPAL INVESTIGATOR

• Eoin O'Currain

  Department of Neonatology, National Maternity Hospital. University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth H Murphy

CONTACT

+353862168183; elizabeth.murphy2@nmh.ie

Anna E Curley

CONTACT

anna.curley@nmh.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 27, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-02

Locations

IE (1)