Asphyxia NeonatorumNCT02572427
Resident Training Enhanced by New Innovations: Teleintubation
A study testing Education for intubation skills and No added education for intubation skills in people with Asphyxia Neonatorum, run by University of Arkansas.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asphyxia Neonatorum
- What is being tested?
- Education for intubation skills and No added education for intubation skills
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pediatric residents
Who cannot join
- Residents from other departments
- Neonatology fellows
- Medical students
- Medical school Faculty
About this study
Official title: Video Laryngoscopy for Enhancing and Maintaining Intubation Skills
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
Read the detailed description
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.
- Conditions
- Asphyxia Neonatorum
- Being tested
- Education for intubation skills, No added education for intubation skills
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education for intubation skillsOther
Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab.
No added education for intubation skillsOther
Routine training in neonatal resuscitation but no added experience in simulation lab.
| Study group | Role | What they receive |
|---|---|---|
| Education for intubation skills | Experimental | 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. Receives: Other: Education for intubation skills |
| No added education for intubation skills | Active comparator | Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns. Receives: Other: No added education for intubation skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skill in Intubating Neonatal Manikin
Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab
Measured: Up to two minutes
Secondary outcomes (1)
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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startSep 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asphyxia NeonatorumStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard W Hall, M.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572427
- Sponsor's protocol ID
- 202043
- Status last verified
- Jul 2016
- First submitted
- 6 Oct 2015
- Last updated
- 5 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Laryngoscopy for Enhancing and Maintaining Intubation Skills
- ClinicalTrials.gov ID
- NCT02572427
- Acronym / sponsor ID
- 202043
- Conditions
- Asphyxia Neonatorum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Posted 15 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education for intubation skills | Experimental | Other: Education for intubation skillsInterventions: 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. |
| No added education for intubation skills | Active comparator | Other: No added education for intubation skillsInterventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pediatric residents
Key exclusion criteria (4 listed)
- Residents from other departments
- Neonatology fellows
- Medical students
- Medical school Faculty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education for intubation skillsRoutine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab. | Other | Education for intubation skills |
| No added education for intubation skillsRoutine training in neonatal resuscitation but no added experience in simulation lab. | Other | No added education for intubation skills |
Primary outcome
Skill in Intubating Neonatal Manikin
Time frame: Up to two minutes
Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab
1 secondary outcome
Knowledge Concerning Intubation of Neonates
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard W Hall, M.D. principal investigator
University of Arkansas
Questions about this trial
What is this clinical trial studying?
A study testing Education for intubation skills and No added education for intubation skills in people with Asphyxia Neonatorum, run by University of Arkansas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skill in Intubating Neonatal Manikin (time frame: Up to two minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.