Intubation; Difficult or Failed
Conditions
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.
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.
Interventions
PROCEDUREIntervention: 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
OTHERIntervention: Control No Training
• Does not receive simulation training with PI. Only standard training.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Intubation Encounters on Live Neonates | 1 month- neonatal intensive care unit (NICU) rotation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Intubations on the First Attempt | 1 month- NICU rotation | 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. |
| Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation | 1 month- NICU rotation | The mean number of intubation encounters performed by each resident during their NICU rotation was compared between the Control and Intervention groups. |
| Change in Time to Intubate the Mannequin | 1 month- NICU rotation | 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. |
Countries
United States
Participant flow
Pre-assignment details
102 residents were approached for enrollment. 102 residents were consented and randomized to intervention or control based on month of NICU rotation.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control: No Training Residents received standard training consisting of intern orientation. | 51 |
| 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. | 51 |
| Total | 102 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 51 Participants | 102 Participants |
| Baseline Successful Intubation Rate 0-25% | 9 Participants | 9 Participants | 18 Participants |
| Baseline Successful Intubation Rate 25-50% | 6 Participants | 3 Participants | 9 Participants |
| Baseline Successful Intubation Rate 50-75% | 12 Participants | 8 Participants | 20 Participants |
| Baseline Successful Intubation Rate 75-100% | 6 Participants | 9 Participants | 15 Participants |
| Baseline Successful Intubation Rate Not Applicable | 18 Participants | 22 Participants | 40 Participants |
| Comfort with Intubation Comfortable | 8 Participants | 10 Participants | 18 Participants |
| Comfort with Intubation Neutral | 9 Participants | 7 Participants | 16 Participants |
| Comfort with Intubation Not very comfortable | 22 Participants | 24 Participants | 46 Participants |
| Comfort with Intubation Somewhat comfortable | 12 Participants | 10 Participants | 22 Participants |
| Comfort with Intubation Very comfortable | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 48 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Level of Training (year) First year | 30 Participants | 36 Participants | 66 Participants |
| Level of Training (year) Fourth Year | 0 Participants | 2 Participants | 2 Participants |
| Level of Training (year) Second year | 14 Participants | 5 Participants | 19 Participants |
| Level of Training (year) Third year | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment United States | 51 Participants | 51 Participants | 102 Participants |
| Sex: Female, Male Female | 34 Participants | 33 Participants | 67 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
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.
Time frame: 1 month- neonatal intensive care unit (NICU) rotation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Successful Intubation Encounters on Live Neonates | 1.02 Successful Intubation Encounters | Standard Error 0.167 |
| Intervention Group | Successful Intubation Encounters on Live Neonates | 1.18 Successful Intubation Encounters | Standard Error 0.183 |
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.
Time frame: 1 month- NICU rotation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Time to Intubate the Mannequin | 18.6 Seconds | Standard Error 9.61 |
| Intervention Group | Change in Time to Intubate the Mannequin | 37.6 Seconds | Standard Error 8.7 |
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.
Time frame: 1 month- NICU rotation
Population: Six residents in the Control group did not report the number of successful intubation encounters completed with only one attempt.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Successful Intubations on the First Attempt | 0.578 Successful First Attempt Intubations | Standard Error 0.133 |
| Intervention Group | Successful Intubations on the First Attempt | 0.840 Successful First Attempt Intubations | Standard Error 0.161 |
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.
Time frame: 1 month- NICU rotation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation | 1.82 Intubation Encounters | Standard Error 0.189 |
| Intervention Group | Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation | 2.33 Intubation Encounters | Standard Error 0.214 |