Intubation Clinical Trial
Official title:
Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study
Verified date | January 2022 |
Source | University Hospital Padova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
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. |
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital of Padova | Padova |
Lead Sponsor | Collaborator |
---|---|
University Hospital Padova |
Italy,
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
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 |
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