Pediatric HousestaffNCT00562744
Effect of Simulation on PALS Training
A study testing Simulation in people with Pediatric Housestaff, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Patient simulation is a new and expanding technology that has proven effective as a teaching tool in various clinical settings, but data on pediatric simulation is lacking. Mock resuscitation scenarios have been shown in prior studies to be effective for improving knowledge, skill, and confidence in pediatric… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatric Housestaff
- What is being tested?
- Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2007
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PGY 1 or 2 in pediatrics at CHOP, St. Christopher's Hospital for Children, or A.I. DuPont Hospital for Children
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High-Fidelity Simulation on Pediatric Advanced Life Support Training in Pediatric Housestaff: a Randomized Trial
Patient simulation is a new and expanding technology that has proven effective as a teaching tool in various clinical settings, but data on pediatric simulation is lacking. Mock resuscitation scenarios have been shown in prior studies to be effective for improving knowledge, skill, and confidence in pediatric housestaff. Our objective is to assess the utility of a training program utilizing a human patient simulator of an infant as a teaching tool for pediatric housestaff training in resuscitation skills. We hypothesize that mock resuscitation exercises performed by pediatric housestaff on a patient simulator will result in improved performance on test scenarios when compared to the same training on a standard manikin.
Read the detailed description
Patient simulation is a new and expanding technology that has proven effective as a teaching tool in various clinical settings, but data on pediatric simulation is lacking. Mock resuscitation scenarios have been shown in prior studies to be effective for improving knowledge, skill, and confidence in pediatric housestaff. Our objective is to assess the utility of a training program utilizing a human patient simulator of an infant as a teaching tool for pediatric housestaff training in resuscitation skills. We hypothesize that mock resuscitation exercises performed by pediatric housestaff on a patient simulator will result in improved performance on test scenarios when compared to the same training on a standard manikin.
We propose a randomized trial of pediatric residents of identical training levels from three children's hospitals. Participants will be assigned to a control group or an intervention group. The control group will undertake mock resuscitation scenarios on a standard manikin; the intervention group will perform the same exercises on a simulator. A test scenario will be administered at the end of each set of training scenarios and frequency and timing of a predetermined list of critical clinical assessments and interventions will be recorded. Analysis will consist of a comparison between control and intervention groups for success rates and time to completion for clinical assessments and interventions.
- Conditions
- Pediatric Housestaff
- Being tested
- Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationOther
Use of high-fidelity patient simulator for training and assessment of PALS scenario performance
| Study group | Role | What they receive |
|---|---|---|
| SIM | Experimental | Participants complete training and assessment of performance in PALS scenarios using high-fidelity simulator Receives: Other: Simulation |
| MAN | No intervention | Participants complete training and assessment of performance in PALS scenarios using mannequin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance in mock resuscitation scenarios
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startJan 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric HousestaffStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Medical
- Investigators
- Aaron Donoghue, MD, MSCE, Principal investigator, CHOP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562744
- Sponsor's protocol ID
- 2005-9-4379
- Status last verified
- Nov 2007
- First submitted
- 21 Nov 2007
- Last updated
- 22 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Fidelity Simulation on Pediatric Advanced Life Support Training in Pediatric Housestaff: a Randomized Trial
- ClinicalTrials.gov ID
- NCT00562744
- Acronym / sponsor ID
- 2005-9-4379
- Conditions
- Pediatric Housestaff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Laerdal Medical
- Study start
- Jan 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Nov 2007 (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.
Patient simulation is a new and expanding technology that has proven effective as a teaching tool in various clinical settings, but data on pediatric simulation is lacking. Mock resuscitation scenarios have been shown in prior studies to be effective for improving knowledge, skill, and confidence in pediatric housestaff. Our objective is to assess the utility of a training program utilizing a human patient simulator of an infant as a teaching tool for pediatric housestaff training in resuscitation skills. We hypothesize that mock resuscitation exercises performed by pediatric housestaff on a patient simulator will result in improved performance on test scenarios when compared to the same training on a standard manikin.
Detailed description
Patient simulation is a new and expanding technology that has proven effective as a teaching tool in various clinical settings, but data on pediatric simulation is lacking. Mock resuscitation scenarios have been shown in prior studies to be effective for improving knowledge, skill, and confidence in pediatric housestaff. Our objective is to assess the utility of a training program utilizing a human patient simulator of an infant as a teaching tool for pediatric housestaff training in resuscitation skills. We hypothesize that mock resuscitation exercises performed by pediatric housestaff on a patient simulator will result in improved performance on test scenarios when compared to the same training on a standard manikin.
We propose a randomized trial of pediatric residents of identical training levels from three children's hospitals. Participants will be assigned to a control group or an intervention group. The control group will undertake mock resuscitation scenarios on a standard manikin; the intervention group will perform the same exercises on a simulator. A test scenario will be administered at the end of each set of training scenarios and frequency and timing of a predetermined list of critical clinical assessments and interventions will be recorded. Analysis will consist of a comparison between control and intervention groups for success rates and time to completion for clinical assessments and interventions.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIM | Experimental | Other: SimulationParticipants complete training and assessment of performance in PALS scenarios using high-fidelity simulator |
| MAN | No intervention | –Participants complete training and assessment of performance in PALS scenarios using mannequin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- PGY 1 or 2 in pediatrics at CHOP, St. Christopher's Hospital for Children, or A.I. DuPont Hospital for Children
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SimulationUse of high-fidelity patient simulator for training and assessment of PALS scenario performance | Other | SIM |
Primary outcome
Cognitive performance in mock resuscitation scenarios
Time frame: immediate
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 22 Nov 2007.
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.
Aaron Donoghue, MD, MSCE principal investigator
CHOP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation in people with Pediatric Housestaff, 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 0 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 22 Nov 2007. 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?
Cognitive performance in mock resuscitation scenarios (time frame: immediate). 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 22 Nov 2007.