Orotracheal IntubationJITNCT00631176
"Just-In-Time Training" in Pediatric Airway Management
A study testing Just-In-Time Training in people with Orotracheal Intubation, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This is a prospective interventional study to test the hypothesis that just-in-time training for pediatric airway management may improve patient safety and operational performance of orotracheal intubation and decreases intubation associated events in pediatric residents in the PICU. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orotracheal Intubation
- What is being tested?
- Just-In-Time Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pediatric or Emergency Medicine Residents rotating through PICU in CHOP.
Who cannot join
- Anesthesiology residents
- Residents who had formal US training (ACGME accredited) in Neonatology or Pediatric Critical Care Medicine, Critical Care Medicine or Anesthesiology.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effectiveness of "Just-In-Time" Training With/Without a High Fidelity Simulation on Patient Safety in Airway Management in Pediatric Intensive Care Unit
This is a prospective interventional study to test the hypothesis that just-in-time training for pediatric airway management may improve patient safety and operational performance of orotracheal intubation and decreases intubation associated events in pediatric residents in the PICU. To test the hypothesis that high fidelity simulation may enhance the training efficacy and patient safety in simulation settings.
Read the detailed description
Background:
Appropriate airway management is the most critical point in pediatric resuscitation and pediatric critical care. It remains, however, a challenge for pediatric residents to learn and retain this critical skill. Recent report from our PICU showed pediatric residents participated only 28% of initial orotracheal intubation, and the rate of the first successful endotracheal tube placement was only 38% of all orotracheal intubation attempt. Repetitive poor-skilled intubation attempts may be associated with complication such as dental or laryngeal contusion, and prolonged intubation attempt may be associated with hypoxia and hemodynamic instability. In order to improve the operational performance in the efficacy (first attempt success rate) and safety (minimizing the associated events which could potentially lead to adverse events), a better training method is warranted.
Objectives:
To test the hypothesis that just-in-time training for pediatric airway management may improve patient safety and operational performance of orotracheal intubation and decreases intubation associated events in pediatric residents in the PICU. To test the hypothesis that high fidelity simulation may enhance the training efficacy and patient safety in simulation settings.
Study Design:
This is a prospective interventional study. During the eighteen months of study period, one of two on-call pediatric residents from 7 south PICU (24 beds) will receive 20 minutes of just-in-time pediatric airway management training. This training will occur before their shift starts before the morning round. This training will cover direct laryngoscopy technique, orotracheal intubation technique, confirmation of the tube placement and recognition of associated events. This training will be done with or without high fidelity simulation function. We will use SimBaby (Laerdal, Norway). The assignment will be randomized. The clinical data of orotracheal intubation are collected through NEAR-4 KIDS registry. Primary outcome is a change in a first attempt success rate by the residents in an overtrained group (7 South PICU) compared to standard training group (7 East PICU). The secondary outcome is the rate of resident participation in orotracheal intubation attempt, the number of intubation attempt before successful intubation by residents and the number of intubation associated events. The videotaped performance during the training is analyzed with Healthcare Failure Mode and Effect Analysis (HFMEA) and will be compared between high fidelity simulation training group and low fidelity simulation training group. The evaluation system developed by HFMEA will be validated by a performance of experienced and non-experienced intubators. Furthermore, the real orotracheal intubation team performance in both PICUs will be evaluated with scale by a research assistant. The demographic and training data of participants of real PICU intubations will be collected. No patient identifiable information will be collected. This data will also be kept in a password-protected research computer.
- Conditions
- Orotracheal Intubation
- Being tested
- Just-In-Time Training
- Keywords
- oral intubation, just in time, simulation education, high fidelity training, intubation training, intubation success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just-In-Time TrainingBehavioural
Also called Over training, Intubation training, Rapid Refresher
On-call pediatric residents from 7 south PICU (24 beds) will receive 20 minutes of just-in-time pediatric airway management training. This training will occur before their shift starts before the morning round. This training will cover direct laryngoscopy technique, orotracheal intubation technique, confirmation of the tube placement and recognition of associated events. This training will be done with or without high fidelity simulation function.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Not described Receives: Behavioral: Just-In-Time Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the success of first intubation attempts by a resident.
Measured: per case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJun 2007
- Primary completionSep 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Vinay Nadkarni, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631176
- Sponsor's protocol ID
- 2006-8-4931
- Other IDs
- 5U18HS016678-02
- Acronym
- JIT
- Status last verified
- Jan 2010
- First submitted
- 28 Feb 2008
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of "Just-In-Time" Training With/Without a High Fidelity Simulation on Patient Safety in Airway Management in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00631176
- Acronym / sponsor ID
- JIT / 2006-8-4931
- Conditions
- Orotracheal Intubation
- Keywords
- oral intubation, just in time, simulation education, high fidelity training, intubation training, intubation success
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective interventional study to test the hypothesis that just-in-time training for pediatric airway management may improve patient safety and operational performance of orotracheal intubation and decreases intubation associated events in pediatric residents in the PICU. To test the hypothesis that high fidelity simulation may enhance the training efficacy and patient safety in simulation settings.
Detailed description
Background:
Appropriate airway management is the most critical point in pediatric resuscitation and pediatric critical care. It remains, however, a challenge for pediatric residents to learn and retain this critical skill. Recent report from our PICU showed pediatric residents participated only 28% of initial orotracheal intubation, and the rate of the first successful endotracheal tube placement was only 38% of all orotracheal intubation attempt. Repetitive poor-skilled intubation attempts may be associated with complication such as dental or laryngeal contusion, and prolonged intubation attempt may be associated with hypoxia and hemodynamic instability. In order to improve the operational performance in the efficacy (first attempt success rate) and safety (minimizing the associated events which could potentially lead to adverse events), a better training method is warranted.
Objectives:
To test the hypothesis that just-in-time training for pediatric airway management may improve patient safety and operational performance of orotracheal intubation and decreases intubation associated events in pediatric residents in the PICU. To test the hypothesis that high fidelity simulation may enhance the training efficacy and patient safety in simulation settings.
Study Design:
This is a prospective interventional study. During the eighteen months of study period, one of two on-call pediatric residents from 7 south PICU (24 beds) will receive 20 minutes of just-in-time pediatric airway management training. This training will occur before their shift starts before the morning round. This training will cover direct laryngoscopy technique, orotracheal intubation technique, confirmation of the tube placement and recognition of associated events. This training will be done with or without high fidelity simulation function. We will use SimBaby (Laerdal, Norway). The assignment will be randomized. The clinical data of orotracheal intubation are collected through NEAR-4 KIDS registry. Primary outcome is a change in a first attempt success rate by the residents in an overtrained group (7 South PICU) compared to standard training group (7 East PICU). The secondary outcome is the rate of resident participation in orotracheal intubation attempt, the number of intubation attempt before successful intubation by residents and the number of intubation associated events. The videotaped performance during the training is analyzed with Healthcare Failure Mode and Effect Analysis (HFMEA) and will be compared between high fidelity simulation training group and low fidelity simulation training group. The evaluation system developed by HFMEA will be validated by a performance of experienced and non-experienced intubators. Furthermore, the real orotracheal intubation team performance in both PICUs will be evaluated with scale by a research assistant. The demographic and training data of participants of real PICU intubations will be collected. No patient identifiable information will be collected. This data will also be kept in a password-protected research computer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Behavioral: Just-In-Time Training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pediatric or Emergency Medicine Residents rotating through PICU in CHOP.
Key exclusion criteria (2 listed)
- Anesthesiology residents
- Residents who had formal US training (ACGME accredited) in Neonatology or Pediatric Critical Care Medicine, Critical Care Medicine or Anesthesiology.
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 |
|---|---|---|
| Just-In-Time TrainingAlso: Over training, Intubation training, Rapid RefresherOn-call pediatric residents from 7 south PICU (24 beds) will receive 20 minutes of just-in-time pediatric airway management training. This training will occur before their shift starts before the morning round. This training will cover direct laryngoscopy technique, orotracheal intubation technique, confirmation of the tube placement and recognition of associated events. This training will be done with or without high fidelity simulation function. | Behavioural | 2 |
Primary outcome
The primary endpoint will be the success of first intubation attempts by a resident.
Time frame: per case
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2010.
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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.
Vinay Nadkarni, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Just-In-Time Training in people with Orotracheal Intubation, run by Children's Hospital of Philadelphia 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 2 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 8 Jan 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint will be the success of first intubation attempts by a resident. (time frame: per case). 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 8 Jan 2010.