An interventional study of Education for intubation skills and No added education for intubation skills in Asphyxia Neonatorum, sponsored by University of Arkansas. Completed. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by University of Arkansas · Not applicable, Interventional, and Other
The overall goal of this study was to create a simulation environment with repeated practice for residents and intense, immediate feedback. Repeated simulations for neonatal resuscitation when coupled with clinical experience have been shown to improve resident confidence.The investigators sought to determine if resident exposure to individual training and video laryngoscopy using the C-MAC video laryngoscope would improve cognitive skills and decrease intubation times in a neonatal manikin. The primary outcome was time to intubation after one year. The secondary outcome was the ability to retain cognitive instruction related to intubation
Objective: Tracheal intubation of infants and children is a critical lifesaving skill, but many upper level pediatric residents are unable to successfully intubate neonates or pediatric patients in a timely manner. Simulation has been shown to be effective in teaching procedural skills, but it is not known if improvements in intubation skills can persist. The investigators sought to determine if video laryngoscopy could be used to enhance resident intubation skills that would be retained for one year.
Methods: There were 67 Pediatric and Internal Medicine/Pediatric residents, levels 1-4, who completed the study and were randomized by month of service into non-intervention (NI, n= 36) and intervention (IN, n=31) groups. IN residents observed the intubation portion of the Neonatal Resuscitation Program (NRP) training video and received cognitive instruction and 30 minutes of hands on instruction using a video laryngoscope. At the study's conclusion, 12 months after enrollment, residents completed a survey of intubations of live patients over the past year, a cognitive assessment of intubation, and were timed on intubating a manikin. Results were analyzed by Student's T-Test.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's enrollment of 82 is below the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.
Other: Education for intubation skills
Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.
Other: No added education for intubation skills
Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab.
Routine training in neonatal resuscitation but no added experience in simulation lab.
Skill in Intubating Neonatal Manikin
Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab
Time frame: Up to two minutes
Knowledge Concerning Intubation of Neonates
Score on cognitive test on intubation of neonates.Scores ranged on scale from 0 to 21 , with higher score indicating greater knowledge (better outcome).
Time frame: 30 minutes
| Milestone | Education for Intubation Skills | No Added Education for Intubation Skills |
|---|---|---|
| Started | 37 | 45 |
| Completed | 31 | 36 |
| Not completed | 6 | 9 |
Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab
| seconds | Education for Intubation Skills | No Added Education for Intubation Skills |
|---|---|---|
| Skill in Intubating Neonatal Manikin | 23.4 ± 22.4 | 39.9 ± 38.2 |
Score on cognitive test on intubation of neonates.Scores ranged on scale from 0 to 21 , with higher score indicating greater knowledge (better outcome).
| scores on a scale | Education for Intubation Skills | No Added Education for Intubation Skills |
|---|---|---|
| Knowledge Concerning Intubation of Neonates | 15 ± 1.7 | 13.1 ± 2.3 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Education for Intubation Skills | — | 0/37 (0%) | 0/37 (0%) |
| No Added Education for Intubation Skills | — | 0/45 (0%) | 0/45 (0%) |
| Age, Categorical(Participants) | Education for Intubation Skills | No Added Education for Intubation Skills | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 37 | 45 | 82 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Education for Intubation Skills | No Added Education for Intubation Skills | Total |
|---|---|---|---|
| Female | 21 | 35 | 56 |
| Male | 16 | 10 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Education for Intubation Skills | No Added Education for Intubation Skills | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 4 | 4 |
| Not Hispanic or Latino | 37 | 41 | 78 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Education for Intubation Skills | No Added Education for Intubation Skills | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 4 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 4 |
| White | 31 | 38 | 69 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Education for Intubation Skills | No Added Education for Intubation Skills | Total |
|---|---|---|---|
| United States | 37 | 45 | 82 |
No study locations are listed for this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.