Applied Forces During Neonatal Intubation

Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study

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)

Study Overview

• Status: Completed
• Conditions: Training; Intubation; Manikin; Neonate
• Intervention / Treatment: Procedure: Intubation with traditional laryngoscope; Procedure: Intubation with a straight blade video laryngoscope; Procedure: Intubation with a hyper-angulated video laryngoscope

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35128
    • University Hospital of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intubation with traditional laryngoscope; Participants will be required to intubate the manikin by using a traditional laryngoscope	Procedure: Intubation with traditional laryngoscope; Participants will be invited to intubate the mannequin with a traditional laryngoscope
Experimental: Intubation with a straight blade video laryngoscope; 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 a straight blade video laryngoscope
Experimental: Intubation with hyper-angulated video laryngoscope; Participants will be required to intubate the manikin by using a hyper-angulated video laryngoscope	Procedure: Intubation with a hyper-angulated video laryngoscope; Participants will be asked to intubate the mannequin with a hyper-angulated video laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forces applied to the palate	The 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.	5 minutes
Perceived workload during intubation	Participants will be asked to report their perceived workload during intubation by using a validated tool	20 minutes
Time of intubation	Time elapsed frmo insertion of the laryngoscope in the mouth to his removal	5 minutes

Collaborators and Investigators

• Sponsor: University Hospital Padova

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): January 26, 2022
• Study Completion (Actual): January 26, 2022

Study Registration Dates

• First Submitted: November 28, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NEOUNIPD1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No