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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Control: No Training | Other | Does not receive hands-on intubation training in the Simulation Lab. |
|
| Intervention: Receives Training | Other | Receives hands-on intubation training in the Simulation Lab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention: Receives Training | Procedure | • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W Hall, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36369530 | Derived | Rumpel J, O'Neal L, Kaukis N, Rogers S, Stack J, Hollenberg J, Hall RW. Manikin to patient intubation: does it translate? J Perinatol. 2023 Feb;43(2):233-235. doi: 10.1038/s41372-022-01553-9. Epub 2022 Nov 11. No abstract available. |
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102 residents were approached for enrollment. 102 residents were consented and randomized to intervention or control based on month of NICU rotation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Control: No Training | Does not receive hands-on intubation training in the Simulation Lab. Intervention: Control No Training: • Does not receive simulation training with PI. Only standard training. |
| FG001 | Intervention: Receives Training | Receives hands-on intubation training in the Simulation Lab. Intervention: Receives Training: • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Control: No Training Residents received standard training consisting of intern orientation. |
| BG001 | Intervention Group | Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Successful Intubation Encounters | 1 month- neonatal intensive care unit (NICU) rotation | Intubation Encounters | Intubation Encounters |
|
NICU rotation (1 month)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Control: No Training | Does not receive hands-on intubation training in the Simulation Lab. Intervention: Control No Training: • Does not receive simulation training with PI. Only standard training. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Rumpel, MD | University of Arkansas for Medical Sciences | 501-364-2980 | Jarumpel@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2017 | May 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2017 | Jun 18, 2021 | SAP_001.pdf |
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|
| Intervention: Control No Training | Other | • Does not receive simulation training with PI. Only standard training. |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Level of Training (year) | Count of Participants | Participants |
|
| Comfort with Intubation | Count of Participants | Participants |
|
| Baseline Successful Intubation Rate | Count of Participants | Participants |
|
Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation. |
|
|
| Secondary | 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. | Six residents in the Control group did not report the number of successful intubation encounters completed with only one attempt. | Posted | Mean | Standard Error | Successful First Attempt Intubations | 1 month- NICU rotation |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Intubation Encounters | 1 month- NICU rotation |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | Seconds | 1 month- NICU rotation |
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| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Intervention: Receives Training | Receives hands-on intubation training in the Simulation Lab. Intervention: Receives Training: • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:
| 0 | 51 | 0 | 51 | 0 | 51 |
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