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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct laryngoscope and table at xiphoid level | Active Comparator | Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level |
|
| Videolaryngoscope and table at xiphoid level | Active Comparator | Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level |
|
| Direct laryngoscope and table at umbilical level | Active Comparator | Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level |
|
| Videolaryngoscope and table at umbilical level | Experimental | Participants will be required to intubate the manikin with a video laryngoscope and table at umbilical level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct laryngoscope and table at xiphoid level | Device | Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving the intubation success at the first attempt | The success of the first attempt will be defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer | 30 seconds |
| Total time of intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniele Trevisanuto, MD | Contact | 0498211489 | daniele.trevisanuto@unipd.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34172556 | Background | 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. | |
| 29980290 |
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| Videolaryngoscope and table at xiphoid level | Device | Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level |
|
| Direct laryngoscope and table at umbilical level | Device | Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level |
|
| Videolaryngoscope and table at umbilical level | Device | Participants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level |
|
Time of device positioning will be calculated as the sum of the time of device positioning in all attempts, as the procedure will be repeated in case of incorrect positioning |
| 3 minutes |
| Participant's opinions about the procedure | Participants will report: their preference about table height and device; perceived difficulty using a Likert scale (1= not difficult, 5=very difficult) | 12 hours |
| Background |
| 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. |
| 38709215 | 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. |
| 25596228 | Background | 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. |
| 32152886 | Background | 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. |
| 41191125 | Derived | Cavallin 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. |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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