Applied Forces During Neonatal Intubation

Intubation Clinical Trial

Official title:

Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197868
• Other study ID #: NEOUNIPD1
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: January 26, 2022

Study information

• Verified date: January 2022
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation
• Manikin
• Neonate
• Training

Intervention

Procedure:
• Intubation with traditional laryngoscope
Participants will be invited to intubate the mannequin with a traditional laryngoscope
• Intubation with a straight blade video laryngoscope
Intubation with a straight blade video laryngoscope
• Intubation with a hyper-angulated video laryngoscope
Participants will be asked to intubate the mannequin with a hyper-angulated video laryngoscope

Locations

Country	Name	City	State
Italy	University Hospital of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Review. — View Citation

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 202 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Perceived workload during intubation	Participants will be asked to report their perceived workload during intubation by using a validated tool	20 minutes
Secondary	Time of intubation	Time elapsed frmo insertion of the laryngoscope in the mouth to his removal	5 minutes