Applied Forces During Neonatal Intubation

NCT ID: NCT05197868

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2022-01-26

Brief Summary

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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

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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.

Conditions

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Intubation Training Neonate Manikin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intubation with traditional laryngoscope

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

Group Type ACTIVE_COMPARATOR

Intubation with traditional laryngoscope

Intervention Type PROCEDURE

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

Intubation with a straight blade video laryngoscope

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

Group Type EXPERIMENTAL

Intubation with a straight blade video laryngoscope

Intervention Type PROCEDURE

Intubation with a straight blade video laryngoscope

Intubation with hyper-angulated video laryngoscope

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

Group Type EXPERIMENTAL

Intubation with a hyper-angulated video laryngoscope

Intervention Type PROCEDURE

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

Interventions

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Intubation with traditional laryngoscope

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

Intervention Type PROCEDURE

Intubation with a straight blade video laryngoscope

Intubation with a straight blade video laryngoscope

Intervention Type PROCEDURE

Intubation with a hyper-angulated video laryngoscope

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Padova

OTHER

Sponsor Role lead

Responsible Party

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Daniele Trevisanuto

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Padova

Padua, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 28319487 (View on PubMed)

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.

Reference Type RESULT
PMID: 32152886 (View on PubMed)

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.

Reference Type RESULT
PMID: 29980290 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36788198 (View on PubMed)

Other Identifiers

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NEOUNIPD1

Identifier Type: -

Identifier Source: org_study_id

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