Intubation, Neonatal Disease
Conditions
Keywords
Neonate, Intubation, Direct laryngoscopy, Video laryngoscopy, Forces, Simulation
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.
Interventions
DEVICEDirect laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
DEVICEVideolaryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
DEVICEDirect laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
DEVICEVideolaryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level
Sponsors
University Hospital Padova
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Level III NICU and PICU consultants, and pediatric residents
Exclusion criteria
* Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnitide of applied forces (Newton) | 3 minutes | Magnitude of forces (measured in Newton) applied to the epiglottis and the palate of the neonatal manikin during the intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving the intubation success at the first attempt | 30 seconds | 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 |
| Total time of intubation | 3 minutes | 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 |
| Participant's opinions about the procedure | 12 hours | Participants will report: their preference about table height and device; perceived difficulty using a Likert scale (1= not difficult, 5=very difficult) |
Contacts
Primary ContactDaniele Trevisanuto, MD
Outcome results
None listed