Failed or Difficult Intubation, Sequela, Intubation Complication, Intubation;Difficult
Conditions
Keywords
Intubation, Video Laryngoscope, Coaching/training
Brief summary
The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs.
Detailed description
Tracheal intubation (TI) is the most common life-saving intervention for resuscitation and stabilization of critically ill neonates in Neonatal Intensive Care Units (NICUs).Recently, video laryngoscopy (VL) has become available in neonatal clinical practice to allows trainees and frontline providers to perform standard direct airway visualization (i.e., traditional laryngoscopy) while the supervisor can simultaneously view a real-time video displaying what the laryngoscopist is seeing. However, VL associated coaching during TI has not been rigorously evaluated.The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs. The primary objective of this study is to determine whether the video coaching skill training for neonatology attendings reduces the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years before and after intervention. The secondary objectives are to 1) determine if video coaching training is feasible to all neonatology attending physicians using train the trainer approach with a remote simulation and 2) determine if the video coaching skill competency among neonatology attending physicians who completed the training using a remote simulation
Interventions
DEVICEVL Coaching training using C-MAC video laryngoscope
Each neonatology attending providers will receive a video laryngoscopy coaching training using a C-MAC video laryngoscope and an intubation training manikin available at each site by a site leader. During the training, site leader will act as a trainee confederate, and each neonatology attending provider will be trained to coach a trainee utilizing video images from C-MAC video laryngoscope and a cognitive aid with standardized language in a laminated card. This training part typically takes approximately 15-30 minutes including consenting process. Each site leader will be trained by PI or PI's designee using remote simulation. In this remote simulation, each site leader will coach an actor at the Children's Hospital of Philadelphia (CHOP) using a profile video image and C-MAC video laryngoscopy image through CHOP approved video conferencing software. A standardized language will be taught to each site leader with a cognitive aid (laminated card).
Sponsors
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital of Philadelphia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. VL coach: Neonatology attending physician position at each neonatal ICU, or Senior trainees who are anticipated to graduate within next 6 months to become neonatology attending physicians. 2. VL coach receivers: Trainees (medical students, residents, fellows except those graduating within next 6 months) and frontline providers (nurse practitioners, hospitalists, physician assistants, respiratory therapists, others who perform tracheal intubations under attending physicians' supervision)
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years | 2 years | Reduction in the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years after neonatology attendings receive video coaching skill training. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching | 18 months | Intubations with VL coaching vs. no VL coaching (incl: DL&VL) can reduce severe oxygen desaturation: Oxygen desaturation defined as highest -lowest SpO2 during the intubation is \>20% (absolute value). Intervention timing was randomized based on the site size. |
Countries
Canada, Singapore, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre-Intervention Intubations before VL coaching using train-the-trainer mechanism was implemented. | 458 |
| Post-Intervention Intubations after VL coaching using train-the-trainer mechanism was implemented. | 1,054 |
| Total | 1,512 |
Baseline characteristics
| Characteristic | Pre-Intervention | Post-Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 458 Participants | 1054 Participants | 1512 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 14 Participants | 20 Participants |
| Race (NIH/OMB) Asian | 24 Participants | 53 Participants | 77 Participants |
| Race (NIH/OMB) Black or African American | 70 Participants | 161 Participants | 231 Participants |
| Race (NIH/OMB) More than one race | 27 Participants | 63 Participants | 90 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 329 Participants | 759 Participants | 1088 Participants |
| Sex: Female, Male Female | 196 Participants | 452 Participants | 648 Participants |
| Sex: Female, Male Male | 262 Participants | 602 Participants | 864 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 458 | 0 / 1,054 |
| other Total, other adverse events | 0 / 458 | 0 / 1,054 |
| serious Total, serious adverse events | 0 / 458 | 0 / 1,054 |
Outcome results
Primary
Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years
Reduction in the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years after neonatology attendings receive video coaching skill training.
Time frame: 2 years
Population: The primary outcome is comparing the number of participants with intubations before the intervention implementation phase (n=458) and the number of participants with intubations in the post intervention implementation phase (n=1,054), total n=1,512 for outcome 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-Intervention | Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years | Any TIAEs | 138 Participants |
| Pre-Intervention | Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years | Severe TIAEs | 33 Participants |
| Pre-Intervention | Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years | Severe Desaturation (>20%) | 244 Participants |
| Post-Intervention | Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years | Any TIAEs | 214 Participants |
| Post-Intervention | Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years | Severe TIAEs | 51 Participants |
| Post-Intervention | Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years | Severe Desaturation (>20%) | 491 Participants |
Comparison: This statistical analysis applies to all three rows in the post-intervention column. ITT analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)p-value: 0.01595% CI: [0.47, 0.92]t-test, 2 sided
Secondary
Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching
Intubations with VL coaching vs. no VL coaching (incl: DL&VL) can reduce severe oxygen desaturation: Oxygen desaturation defined as highest -lowest SpO2 during the intubation is \>20% (absolute value). Intervention timing was randomized based on the site size.
Time frame: 18 months
Population: The number of participants in this outcome measure include those intubated with VL coaching (n=155) and those intubated without VL coaching (n=984), total n=1,139 for outcome measure 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-Intervention | Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching | Any TIAEs | 23 Participants |
| Pre-Intervention | Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching | Severe TIAEs | 5 Participants |
| Pre-Intervention | Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching | Severe Desaturation (>20%) | 99 Participants |
| Post-Intervention | Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching | Any TIAEs | 209 Participants |
| Post-Intervention | Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching | Severe TIAEs | 49 Participants |
| Post-Intervention | Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching | Severe Desaturation (>20%) | 438 Participants |
Comparison: This statistical analysis applies to all three rows and is a per-protocol analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)p-value: 0.2595% CI: [0.5, 1.2]t-test, 2 sided