NCT05197868

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2022

Completed
Last Updated

February 15, 2022

Status Verified

January 1, 2022

Enrollment Period

6 days

First QC Date

November 28, 2021

Last Update Submit

January 31, 2022

Conditions

IntubationTrainingNeonateManikin

Outcome Measures

Primary Outcomes (1)

  • Forces applied to the epiglottis

    The 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.

    5 minutes

Secondary Outcomes (3)

  • Forces applied to the palate

    5 minutes

  • Perceived workload during intubation

    20 minutes

  • Time of intubation

    5 minutes

Study Arms (3)

Intubation with traditional laryngoscope

ACTIVE COMPARATOR

Participants will be required to intubate the manikin by using a traditional laryngoscope

Procedure: Intubation with traditional laryngoscope

Intubation with a straight blade video laryngoscope

EXPERIMENTAL

Participants will be required to intubate the manikin by using a straight blade video laryngoscope

Procedure: Intubation with a straight blade video laryngoscope

Intubation with hyper-angulated video laryngoscope

EXPERIMENTAL

Participants will be required to intubate the manikin by using a hyper-angulated video laryngoscope

Procedure: Intubation with a hyper-angulated video laryngoscope

Interventions

Intubation with traditional laryngoscopePROCEDURE

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

Intubation with traditional laryngoscope
Intubation with a straight blade video laryngoscopePROCEDURE

Intubation with a straight blade video laryngoscope

Intubation with a straight blade video laryngoscope
Intubation with a hyper-angulated video laryngoscopePROCEDURE

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

Intubation with hyper-angulated video laryngoscope

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Padova

Padua, 35128, Italy

Location

Related Publications (4)

  • Balaban O, Tobias JD. Videolaryngoscopy in Neonates, Infants, and Children. Pediatr Crit Care Med. 2017 May;18(5):477-485. doi: 10.1097/PCC.0000000000001128.

    PMID: 28319487RESULT

  • Gordon JK, Bertram VE, Cavallin F, Parotto M, Cooper RM. Direct versus indirect laryngoscopy using a Macintosh video laryngoscope: a mannequin study comparing applied forces. Can J Anaesth. 2020 May;67(5):515-520. doi: 10.1007/s12630-020-01583-x. Epub 2020 Mar 9.

    PMID: 32152886RESULT

  • Pouppirt NR, Nassar R, Napolitano N, Nawab U, Nishisaki A, Nadkarni V, Ades A, Foglia EE. Association Between Video Laryngoscopy and Adverse Tracheal Intubation-Associated Events in the Neonatal Intensive Care Unit. J Pediatr. 2018 Oct;201:281-284.e1. doi: 10.1016/j.jpeds.2018.05.046. Epub 2018 Jul 3.

    PMID: 29980290RESULT

  • Cavallin F, Sala C, Maglio S, Bua B, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with direct versus indirect laryngoscopy in neonatal intubation: a randomized crossover mannequin study. Can J Anaesth. 2023 May;70(5):861-868. doi: 10.1007/s12630-023-02402-9. Epub 2023 Feb 14.

    PMID: 36788198DERIVED

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 28, 2021

First Posted

January 20, 2022

Study Start

January 20, 2022

Primary Completion

January 26, 2022

Study Completion

January 26, 2022

Last Updated

February 15, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)