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The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.
Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Furthermore, the procedure times are often longer than recommended by international guidelines, and repeated intubation attempts are associated with adverse events in unstable neonates.
Objectives: To compare success and time of intubation through intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
Methods: This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure was the intubation success rate at the first attempt. Secondary outcome measures were the total time needed for the endotracheal tube positioning (calculated as the sum of the time of device positioning in all attempts), and the participant's opinion on using the device (evaluated using a Likert scale).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intubation via laryngeal mask | Experimental | Participants will be required to position the endotracheal tube in the manikin via a laryngeal mask |
|
| Intubation via direct laryngoscope | Active Comparator | Participants will be required to position the endotracheal tube in the manikin via direct laryngoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubating laryngeal mask | Device | Intubation through a laryngeal mask |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 minutes after the initiation of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time of device positioning | 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 after the initiation of the procedure |
| Participant's opinion on difficulty of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniele Trevisanuto | Contact | 3406632734 | daniele.trevisanuto@unipd.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33773829 | Background | Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24. | |
| 15870667 |
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| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Direct laryngoscopy |
| Device |
Intubation by using a direct laryngoscope |
|
Participants will report their opinion on insertion difficulty and overall difficulty using a Likert scale (1= not difficult, 5=very difficult) |
| 5 minutes after end of the procedure |
| Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr. 2005 May;146(5):638-41. doi: 10.1016/j.jpeds.2005.01.029. |
| 28409758 | Background | Sawyer T, Foglia E, Hatch LD, Moussa A, Ades A, Johnston L, Nishisaki A. Improving neonatal intubation safety: A journey of a thousand miles. J Neonatal Perinatal Med. 2017;10(2):125-131. doi: 10.3233/NPM-171686. |
| 20112078 | Background | Gerstein NS, Braude DA, Hung O, Sanders JC, Murphy MF. The Fastrach Intubating Laryngeal Mask Airway: an overview and update. Can J Anaesth. 2010 Jun;57(6):588-601. doi: 10.1007/s12630-010-9272-x. Epub 2010 Jan 29. |
| 27470688 | Background | Sauer CW, Kong JY, Vaucher YE, Finer N, Proudfoot JA, Boutin MA, Leone TA. Intubation Attempts Increase the Risk for Severe Intraventricular Hemorrhage in Preterm Infants-A Retrospective Cohort Study. J Pediatr. 2016 Oct;177:108-113. doi: 10.1016/j.jpeds.2016.06.051. Epub 2016 Jul 26. |
| 40542416 | Derived | Monfredini C, Cavallin F, Ouedraogo P, Ezzahraoui L, Pasta E, Trevisanuto D, Villani PE. Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial. Ital J Pediatr. 2025 Jun 20;51(1):196. doi: 10.1186/s13052-025-01988-8. |