Using Video Laryngoscopy for Neonatal Intubation

October 2, 2023 updated by: University of Rochester

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1st and 2nd Year Pediatric and Medicine-Pediatric Residents at the University of Rochester

Exclusion Criteria:

  • Residents who declined participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video Laryngoscopy Group
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
Residents intubate using video laryngoscopy.
Other Names:
  • Technology-Assisted Instruction
Active Comparator: Traditional Laryngoscopy Group
Subjects enrolled in this arm, received traditional guidance while they performed direct neonatal intubations in the NICU.
Other: Traditional Laryngoscopy
Residents intubate without using video laryngoscopy.
Other Names:
  • Traditional Instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Successful Intubations
Time Frame: 12 months
A successful intubation is defined as the placement of an endotracheal tube in the infant's trachea within two attempts.
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of successful intubations by resident year
Time Frame: 12 months
12 months
Number of residents with successful intubations on the first and subsequent patients
Time Frame: 12 months
12 months
Average length of time of intubation attempts
Time Frame: 12 months
12 months
Number of both serious and non-serious adverse events
Time Frame: 12 months
12 months
Number of successful intubations by residency program
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Rita Dadiz, DO, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimated)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSRB00051876

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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