Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table
NCT ID: NCT06474572
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
32 participants
INTERVENTIONAL
2024-06-30
2024-06-30
Brief Summary
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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.
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Detailed Description
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Objectives: 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' opinions on the procedures were investigated.
Methods: 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. Participants will be Level III NICU/PICU consultants, and pediatric residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the forces applied on the neonatal manikin during the intubation. The secondary outcome measures will be the success of the first attempt, the total time of intubation, and participants' opinions about the procedure.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Direct laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Direct laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Videolaryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Videolaryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Direct laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Direct laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Videolaryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a video laryngoscope and table at umbilical level
Videolaryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level
Interventions
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Direct laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Videolaryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Direct laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Videolaryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
65 Years
ALL
Yes
Sponsors
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University Hospital Padova
OTHER
Responsible Party
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Daniele Trevisanuto
Associate Professor
Central Contacts
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References
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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.
Pouppirt 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.
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.
Xue 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.
Gordon 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.
Other Identifiers
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NEOUNIPD5(2024)
Identifier Type: -
Identifier Source: org_study_id
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