An interventional study of Direct laryngoscope and table at xiphoid level and Videolaryngoscope and table at xiphoid level in Neonatal Disease and Intubation, sponsored by University Hospital Padova. Not yet recruiting. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by University Hospital Padova · Not applicable, Interventional, and Treatment
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.
140 studies on the registry are indexed under Infant, Newborn, Diseases; 29 are open to participants now.
This study's planned enrollment of 32 is below the median of 92 across 86 interventional studies indexed under Infant, Newborn, Diseases.
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Exclusion Criteria:
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Device: Direct laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Device: Videolaryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Device: Direct laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a video laryngoscope and table at umbilical level
Device: Videolaryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level
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
Time frame: 3 minutes
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
Time frame: 30 seconds
Total time of intubation
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
Time frame: 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)
Time frame: 12 hours
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University Hospital Padova