Intubation; Difficult or FailedNCT03046966
Manikin To Patient Intubation: Does It Translate?
A study testing Intervention: Receives Training in people with Intubation; Difficult or Failed, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Intervention: Receives Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 28 Feb 2020
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any pediatric resident who does not wish to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the 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.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Intervention: Receives Training, Intervention: Control No Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Receives TrainingProcedure or surgery
- 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
Intervention: Control No TrainingOther
- Does not receive simulation training with PI. Only standard training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Control: No Training | Other | Does not receive hands-on intubation training in the Simulation Lab. Receives: Other: Intervention: Control No Training |
| Intervention: Receives Training | Other | Receives hands-on intubation training in the Simulation Lab. Receives: Procedure: Intervention: Receives Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month- neonatal intensive care unit (NICU) rotation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1 month- NICU rotation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Oct 2017
- Primary completion27 Feb 2020
- Study completion28 Feb 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard W Hall, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046966
- Sponsor's protocol ID
- 205053
- Status last verified
- Apr 2021
- First submitted
- 2 Feb 2017
- Last updated
- 7 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36369530
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manikin To Patient Intubation: Does It Translate?
- ClinicalTrials.gov ID
- NCT03046966
- Acronym / sponsor ID
- 205053
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Control: No Training | Other | Other: Intervention: Control No TrainingDoes not receive hands-on intubation training in the Simulation Lab. |
| Intervention: Receives Training | Other | Procedure: Intervention: Receives TrainingReceives hands-on intubation training in the Simulation Lab. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any pediatric resident who does not wish to participate
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 |
|---|---|---|
| Intervention: 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 | Procedure or surgery | Intervention: Receives Training |
| Intervention: Control No Training• Does not receive simulation training with PI. Only standard training. | Other | Intervention Control: No Training |
Primary outcome
Successful Intubation Encounters on Live Neonates
Time frame: 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.
3 secondary outcomes
Successful Intubations on the First Attempt
Time frame: 1 month- NICU rotation
Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation
Time frame: 1 month- NICU rotation
Change in Time to Intubate the Mannequin
Time frame: 1 month- NICU rotation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36369530Rumpel 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.
- Individual participant dataSharing planned: No
Related trials for Intubation; Difficult or Failed
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Difficult Airway Prediction by Integrating STOP-BANG Criteria
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Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
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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, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Receives Training in people with Intubation; Difficult or Failed, run by University of Arkansas at 1 site in United States.
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 1 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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 7 Jul 2021). 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?
Successful Intubation Encounters on Live Neonates (time frame: 1 month- neonatal intensive care unit (NICU) rotation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046966, which also lists 1 linked publication.
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 7 Jul 2021.