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Using Video Laryngoscopy for Neonatal Intubation

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ClinicalTrials.gov Identifier: NCT03035175
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Rita Dadiz, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Education, Medical Other: Video Laryngoscopy Other: Traditional Laryngoscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Control Trial: Does Guidance Using Video Laryngoscopy Improve Residents' Success in Neonatal Intubation?
Study Start Date : May 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

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 Name: 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 Name: Traditional Instruction




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of successful intubations by resident year [ Time Frame: 12 months ]
  2. Number of residents with successful intubations on the first and subsequent patients [ Time Frame: 12 months ]
  3. Average length of time of intubation attempts [ Time Frame: 12 months ]
  4. Number of both serious and non-serious adverse events [ Time Frame: 12 months ]
  5. Number of successful intubations by residency program [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Residents who declined participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035175


Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Rita Dadiz, DO University of Rochester

Publications:
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Responsible Party: Rita Dadiz, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03035175     History of Changes
Other Study ID Numbers: RSRB00051876
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rita Dadiz, University of Rochester:
Residences
Video Laryngoscopy
Intubations
Neonatal
NICU
neonates
Medical Education