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Manikin To Patient Intubation: Does It Translate?

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ClinicalTrials.gov Identifier: NCT03046966
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : November 20, 2017
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment
Intubation; Difficult or Failed Procedure: Intervention: Receives Training Other: Intervention: Control No Training

Detailed Description:

Current findings suggest that the training of pediatric residents is not sufficient prior to "live" tracheal intubations in the critical care setting. The current one to two days of airway management training as a part of resuscitation training (such as Pediatric Advanced Life Support (PALS) or Neonatal Resuscitation Program (NRP) is not sufficient to provide safe intubation skills.

This study will develop and implement tracheal intubation training using concepts of deliberate practice modeled after Ericsson. The concepts include focused training on a specific task, immediate feedback, time for problem solving and evaluation, and opportunities for repeated performance using a manikin. This proposal is an attempt to develop such a training model. Video recordings of live intubations will be reviewed and evaluated. The data between the two groups will be compared to see if there is improved intubation skills of live patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Manikin To Patient Intubation: Does It Translate?
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Intervention Control: No Training
Does not receive hands-on intubation training in the Simulation Lab.
Other: Intervention: Control No Training
• Does not receive simulation training with PI. Only standard training.
Intervention: Receives Training
Receives hands-on intubation training in the Simulation Lab.
Procedure: Intervention: Receives Training

• 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

Primary Outcome Measures :
  1. Improvement in intubation skills between residents that receive training versus no training as measured by number of attempts for successful intubation. [ Time Frame: 30 seconds per intubation attempt ]
    Residents will be given two 30 second attempts for successful intubation of infant. If first attempt is unsuccessful, then the patient will be manually oxygenated using bag for 30 seconds and then a second attempt at intubation will occur.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any pediatric resident who does not wish to participate

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): NCT03046966

Contact: Jimmie A Birdsong, RN 501-526-7838 jabirdsong@uams.edu

United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Jimmie A Birdsong, RN    501-526-7838    jabirdsong@uams.edu   
Sponsors and Collaborators
University of Arkansas
National Institutes of Health (NIH)
Principal Investigator: Richard W Hall, MD University of Arkansas

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03046966     History of Changes
Other Study ID Numbers: 205053
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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