Clinical trial NCT06474572: Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table
Official title: Applied Forces During Neonatal Intubation With Direct and Video Laryngoscopy at Different Heights of the Resuscitation Table: a Randomized Crossover Manikin Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neonatal Disease
Intubation
Keywords: Neonate
Intubation
Direct laryngoscopy
Video laryngoscopy
Forces
Simulation
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Some procedure-related aspects may affect the quality of the intubation. Optimizing the relative height between patient and operator may improve intubation procedures.

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.

Eligibility criteria: Inclusion Criteria:

* Level III NICU and PICU consultants, and pediatric residents

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Magnitide of applied forces (Newton)
timeFrame: 3 minutes
Secondary outcomes:
measure: Percentage of participants achieving the intubation success at the first attempt
timeFrame: 30 seconds
measure: Total time of intubation
timeFrame: 3 minutes
measure: Participant's opinions about the procedure
timeFrame: 12 hours
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.