Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table
IntTab
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
The study aims to compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time and participants' opinion on the procedures were investigated. This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedJune 25, 2024
June 1, 2024
Same day
May 28, 2024
June 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Magnitide of applied forces (Newton)
Magnitude of forces (measured in Newton) applied to the epiglottis and the palate of the neonatal manikin during the intubation
3 minutes
Secondary Outcomes (3)
Percentage of participants achieving the intubation success at the first attempt
30 seconds
Total time of intubation
3 minutes
Participant's opinions about the procedure
12 hours
Study Arms (4)
Direct laryngoscope and table at xiphoid level
ACTIVE COMPARATORParticipants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Videolaryngoscope and table at xiphoid level
ACTIVE COMPARATORParticipants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Direct laryngoscope and table at umbilical level
ACTIVE COMPARATORParticipants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Videolaryngoscope and table at umbilical level
EXPERIMENTALParticipants will be required to intubate the manikin with a video laryngoscope and table at umbilical level
Interventions
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level
Eligibility Criteria
You may qualify if:
- Level III NICU and PICU consultants, and pediatric residents
You may not qualify if:
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Evans P, Shults J, Weinberg DD, Napolitano N, Ades A, Johnston L, Levit O, Brei B, Krick J, Sawyer T, Glass K, Wile M, Hollenberg J, Rumpel J, Moussa A, Verreault A, Abou Mehrem A, Howlett A, McKanna J, Nishisaki A, Foglia EE. Intubation Competence During Neonatal Fellowship Training. Pediatrics. 2021 Jul;148(1):e2020036145. doi: 10.1542/peds.2020-036145. Epub 2021 Jun 25.
PMID: 34172556BACKGROUNDPouppirt NR, Nassar R, Napolitano N, Nawab U, Nishisaki A, Nadkarni V, Ades A, Foglia EE. Association Between Video Laryngoscopy and Adverse Tracheal Intubation-Associated Events in the Neonatal Intensive Care Unit. J Pediatr. 2018 Oct;201:281-284.e1. doi: 10.1016/j.jpeds.2018.05.046. Epub 2018 Jul 3.
PMID: 29980290BACKGROUNDGeraghty 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: 38709215BACKGROUNDXue FS, Li RP, Liu GP. Dynamic optimization of height relation between anaesthetist's chest and patient's face during tracheal intubation. Br J Anaesth. 2015 Feb;114(2):348-9. doi: 10.1093/bja/aeu479. No abstract available.
PMID: 25596228BACKGROUNDGordon JK, Bertram VE, Cavallin F, Parotto M, Cooper RM. Direct versus indirect laryngoscopy using a Macintosh video laryngoscope: a mannequin study comparing applied forces. Can J Anaesth. 2020 May;67(5):515-520. doi: 10.1007/s12630-020-01583-x. Epub 2020 Mar 9.
PMID: 32152886BACKGROUNDCavallin F, Pasquali G, Maglio S, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces during neonatal intubation with direct and video laryngoscopy at different bed elevations: a randomized crossover manikin study. Eur J Pediatr. 2025 Nov 5;184(12):732. doi: 10.1007/s00431-025-06524-8.
PMID: 41191125DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 25, 2024
Study Start
June 1, 2024
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
June 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share