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NCT03035175 Clinical Trial

Using Video Laryngoscopy for Neonatal Intubation

Education, Medical Clinical Trial

Official title:
A Randomized Control Trial: Does Guidance Using Video Laryngoscopy Improve Residents' Success in Neonatal Intubation?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03035175
Other study ID # RSRB00051876
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date August 2016

Study information
Verified date October 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

To evaluate whether residents who receive guidance from a supervisor concurrently viewing the neonate's airway via video laryngoscopy will have a higher rate of successful neonatal intubations than residents receiving guidance using traditional direct laryngoscopy. The investigators conducted a randomized controlled trial involving 48 first and second year pediatric and medicine-pediatric residents who received either video-facilitated (VDL) or traditional (TDL) supervisor guidance during direct laryngoscopy. Residents attempted intubations in the neonatal intensive care unit according to their randomization group. The primary outcome was a successful intubation that occurred within two attempts.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date August 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1st and 2nd Year Pediatric and Medicine-Pediatric Residents at the University of Rochester Exclusion Criteria: - Residents who declined participation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Video Laryngoscopy
Residents intubate using video laryngoscopy.
• Traditional Laryngoscopy
Residents intubate without using video laryngoscopy.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Rochester

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Number of successful intubations by resident year 12 months
Secondary Number of residents with successful intubations on the first and subsequent patients 12 months
Secondary Average length of time of intubation attempts 12 months
Secondary Number of both serious and non-serious adverse events 12 months
Secondary Number of successful intubations by residency program 12 months
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