Manikin To Patient Intubation: Does It Translate?

NCT03046966 | Completed Results

• 1 other identifier: 205053
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a new approach to the instruction of pediatric residents in the skill of neonatal intubation. Half of the participants will receive focused simulation training and cognitive instruction while the other half will not. The collected data from both groups will be compared.

Conditions

Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (1)

• Successful Intubation Encounters on Live Neonates

  Residents reported the number of successful intubation encounters they performed during their one month long NICU rotation. A successful intubation encounter is an intubation procedure where the resident successfully placed the the endotracheal tube (ETT) through the vocal cords into the trachea. Placement was confirmed with xray, chest auscultation, improvement in heart rate, and CO2 detectors.

  1 month- neonatal intensive care unit (NICU) rotation

Secondary Outcomes (3)

• Successful Intubations on the First Attempt

  1 month- NICU rotation

• Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation

  1 month- NICU rotation

• Change in Time to Intubate the Mannequin

  1 month- NICU rotation

Study Arms (2)

Intervention Control: No Training

OTHER

Does not receive hands-on intubation training in the Simulation Lab.

Other: Intervention: Control No Training

Intervention: Receives Training

OTHER

Receives hands-on intubation training in the Simulation Lab.

Procedure: Intervention: Receives Training

Interventions

Intervention: Receives Training PROCEDURE

• Complete a Hands-on Intubation in the Simulation Lab with PI instructing: * Using state of the art technology, a Storz C-MAC video laryngoscope * Identifying anatomical landmarks * Practice on the manikin until intubation occurs within 15 seconds

Intervention: Receives Training

Intervention: Control No Training OTHER

• Does not receive simulation training with PI. Only standard training.

Intervention Control: No Training

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female residents from 18-89 years of age who have been assigned to the Neonatal Intensive Care Unit (NICU) for a monthly rotation are eligible to participate. At the beginning of all NICU rotations, all pediatric residents will be invited to participate in this research.

You may not qualify if:

• Any pediatric resident who does not wish to participate

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Rumpel J, O'Neal L, Kaukis N, Rogers S, Stack J, Hollenberg J, Hall RW. Manikin to patient intubation: does it translate? J Perinatol. 2023 Feb;43(2):233-235. doi: 10.1038/s41372-022-01553-9. Epub 2022 Nov 11. No abstract available.

  PMID: 36369530 DERIVED

Results Point of Contact

• Title: Jennifer Rumpel, MD
• Organization: University of Arkansas for Medical Sciences

Jarumpel@uams.edu

501-364-2980

Study Officials

• Richard W Hall, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 8, 2017
• Study Start: October 1, 2017
• Primary Completion: February 27, 2020
• Study Completion: February 28, 2020
• Last Updated: July 7, 2021
• Results First Posted: July 7, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)