Manikin To Patient Intubation: Does It Translate?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Manikin To Patient Intubation: Does It Translate?

Conditions
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Intubation; Difficult or Failed

Intervention / Treatment
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* Procedure: Intervention: Receives Training
* Other: Intervention: Control No Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Control: No Training<br>Does not receive hands-on intubation training in the Simulation Lab. | Other: Intervention: Control No Training<br>* • Does not receive simulation training with PI. Only standard training.<br>|
| Other: Intervention: Receives Training<br>Receives hands-on intubation training in the Simulation Lab. | Procedure: Intervention: Receives Training<br>* • 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Intubation Encounters on Live Neonates | Residents reported the number of successful intubation encounters they performed during their one month long NICU rotation. A successful intubation encounter is an intubation procedure where the resident successfully placed the the endotracheal tube (ETT) through the vocal cords into the trachea. Placement was confirmed with xray, chest auscultation, improvement in heart rate, and CO2 detectors. | 1 month- neonatal intensive care unit (NICU) rotation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Intubations on the First Attempt | Each resident reported the number of successful intubation encounters requiring one attempt on live infants during their NICU rotation. An intubation attempt occurs any time the laryngoscope enters the neonate's mouth. There can be multiple intubation attempts in one intubation encounter. However this outcome focuses on intubation encounters where the neonate was intubated on the first attempt by the resident. | 1 month- NICU rotation | 
| Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation | The mean number of intubation encounters performed by each resident during their NICU rotation was compared between the Control and Intervention groups. | 1 month- NICU rotation | 
| Change in Time to Intubate the Mannequin | All study residents intubated the mannequin before and after their NICU rotation. The total time of the mannequin intubation encounter was recorded. The difference in the time from end of the NICU rotation and the baseline time (beginning of the NICU rotation) was calculated. | 1 month- NICU rotation |