NCT03035175

Brief Summary

This study examines the effectiveness of utilizing video laryngoscopy to give real-time guidance during neonatal intubations to improve residents' success at performing intubations.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

2.1 years

First QC Date

January 24, 2017

Last Update Submit

October 2, 2023

Conditions

Education, Medical

Keywords

ResidencesVideo LaryngoscopyIntubationsNeonatalNICUneonatesMedical Education

Outcome Measures

Primary Outcomes (1)

  • Number of Successful Intubations

    A successful intubation is defined as the placement of an endotracheal tube in the infant's trachea within two attempts.

    12 months

Secondary Outcomes (5)

  • Number of successful intubations by resident year

    12 months

  • Number of residents with successful intubations on the first and subsequent patients

    12 months

  • Average length of time of intubation attempts

    12 months

  • Number of both serious and non-serious adverse events

    12 months

  • Number of successful intubations by residency program

    12 months

Study Arms (2)

Video Laryngoscopy Group

EXPERIMENTAL

Subjects enrolled in this arm received real-time guidance from a supervisor utilizing the screen of the video laryngoscope while the subjects performed direct neonatal intubations in the NICU.

Other: Video Laryngoscopy

Traditional Laryngoscopy Group

ACTIVE COMPARATOR

Subjects enrolled in this arm, received traditional guidance while they performed direct neonatal intubations in the NICU.

Other: Traditional Laryngoscopy

Interventions

Video LaryngoscopyOTHER

Residents intubate using video laryngoscopy.

Also known as: Technology-Assisted Instruction
Video Laryngoscopy Group
Traditional LaryngoscopyOTHER

Residents intubate without using video laryngoscopy.

Also known as: Traditional Instruction
Traditional Laryngoscopy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • st and 2nd Year Pediatric and Medicine-Pediatric Residents at the University of Rochester

You may not qualify if:

  • Residents who declined participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013 Oct;84(10):1359-64. doi: 10.1016/j.resuscitation.2013.03.014. Epub 2013 Apr 3.

    PMID: 23562374BACKGROUND

  • Falck AJ, Escobedo MB, Baillargeon JG, Villard LG, Gunkel JH. Proficiency of pediatric residents in performing neonatal endotracheal intubation. Pediatrics. 2003 Dec;112(6 Pt 1):1242-7. doi: 10.1542/peds.112.6.1242.

    PMID: 14654592BACKGROUND

  • O'Shea JE, Thio M, Kamlin CO, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG. Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial. Pediatrics. 2015 Nov;136(5):912-9. doi: 10.1542/peds.2015-1028. Epub 2015 Oct 19.

    PMID: 26482669BACKGROUND

  • Moussa A, Luangxay Y, Tremblay S, Lavoie J, Aube G, Savoie E, Lachance C. Videolaryngoscope for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20152156. doi: 10.1542/peds.2015-2156. Epub 2016 Feb 12.

    PMID: 26908701BACKGROUND

Study Officials

  • Rita Dadiz, DO

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 27, 2017

Study Start

May 1, 2014

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share