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Applied Forces During Neonatal Intubation

Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05197868
Enrollment
30
Registered
2022-01-20
Start date
2022-01-20
Completion date
2022-01-26
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Manikin, Neonate, Training

Brief summary

This study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade)

Detailed description

This is a randomized controlled crossover trial of intubation with three laryngoscope devices in a neonatal manikin model. Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study. Participants in the ABC arm will be assigned to perform the intubation with a traditional laryngoscope (A), followed by the intubation with a straight blade video laryngoscope (B) and by the intubation with hyper-angulated video laryngoscope (C). Participants in different arms will be assigned to perform the intubations in different sequences (BCA/CAB/ACB/BAC/CBA). The primary outcome measure will be the forces applied to mannequin oro-tracheal tissues during intubation with the three kinds of tools. The secondary outcome measures will be the perceived workload during intubation and intubation time with the traditional laryngoscope and the video laryngoscope.

Interventions

PROCEDUREIntubation with traditional laryngoscope

Participants will be invited to intubate the mannequin with a traditional laryngoscope

PROCEDUREIntubation with a straight blade video laryngoscope

Intubation with a straight blade video laryngoscope

PROCEDUREIntubation with a hyper-angulated video laryngoscope

Participants will be asked to intubate the mannequin with a hyper-angulated video laryngoscope

Sponsors

University Hospital Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study.

Exclusion criteria

* Refusal to participate.

Design outcomes

Primary

MeasureTime frameDescription
Forces applied to the epiglottis5 minutesThe peak force (maximum force, expressed as Newton) applied on the epiglottis during intubation will be recorded by sensors positioned on the tip of the laryngoscope's blade.

Secondary

MeasureTime frameDescription
Forces applied to the palate5 minutesThe peak force (maximum force, expressed as Newton) applied on the palate during intubation will be recorded by sensors positioned on the posterior side of the laryngoscope's blade.
Perceived workload during intubation20 minutesParticipants will be asked to report their perceived workload during intubation by using a validated tool
Time of intubation5 minutesTime elapsed frmo insertion of the laryngoscope in the mouth to his removal

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026