Health TrialsbyHealthPanel

Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table

ConditionsNeonatal DiseaseIntubation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorUniversity Hospital Padova

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Level III NICU and PICU consultants, and pediatric residents

Disqualifiers

Refusal to participate

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

  • 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

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Direct laryngoscope and table at xiphoid levelActive comparator 1 intervention
Group B: Videolaryngoscope and table at xiphoid levelActive comparator 1 intervention
Group C: Direct laryngoscope and table at umbilical levelActive comparator 1 intervention
Group D: Videolaryngoscope and table at umbilical levelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Padova

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: