Neonatal Disease, Intubation; Difficult or Failed
Conditions
Brief summary
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.
Detailed description
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).
Interventions
Intubation through a laryngeal mask
DEVICEDirect laryngoscopy
Intubation by using a direct laryngoscope
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 consultants and residents will be eligible to participate in the study
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success at the first attempt | 3 minutes after the initiation of the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of device positioning | 3 minutes after the initiation of the procedure | 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 opinion on difficulty of the procedure | 5 minutes after end of the procedure | Participants will report their opinion on insertion difficulty and overall difficulty using a Likert scale (1= not difficult, 5=very difficult) |
Contacts
Primary ContactDaniele Trevisanuto
Outcome results
None listed