Cardiopulmonary ResuscitationsNCT00884559
Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation
A study testing instruction in people with Cardiopulmonary Resuscitations, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Whether teaching leadership with a short debriefing has a positive influence on the performance of cardiopulmonary resuscitation remains largely unknown. The investigators will assess the sustained efficacy of a short leadership debriefing compared to a technical debriefing in a high fidelity simulated cardiopulmonary… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitations
- What is being tested?
- instruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2005to Apr 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteer medical students
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation: a Randomised Controlled Trial
Whether teaching leadership with a short debriefing has a positive influence on the performance of cardiopulmonary resuscitation remains largely unknown. The investigators will assess the sustained efficacy of a short leadership debriefing compared to a technical debriefing in a high fidelity simulated cardiopulmonary resuscitation.
Read the detailed description
Context:
Whether the performance of cardiopulmonary resuscitation can be positively influenced by teaching leadership with a short debriefing remains largely unknown
Objective:
To test the hypothesis that (1) leadership instruction are effective and (2) improved leadership results in better performance in a high fidelity simulated cardiopulmonary resuscitation.
Design:
Prospective, randomized-controlled superiority trial
Setting:
Simulator Center of the University Hospital Basel in Switzerland
Patients or Other Participants:
237 volunteer medical students in teams of 3
Intervention:
During a baseline visit, the medical students participate in a video-taped simulated witnessed cardiac arrest. Participants are randomized to receive thereafter a short video-assisted debriefing focusing either on correct positions of arms and shoulders (technical debriefing) or on leadership and communication to enhance team coordination (leadership debriefing). A follow-up simulation is conducted after 4 months. Leadership utterances, technical skills and the resuscitation performance of the teams are compared based on videotapes coded by two independent researchers.
Main Outcome Measures:
The primary outcomes for this study are the amount of hands-on time in the first 180 seconds after the onset of the cardiac arrest and the time elapsed until cardiopulmonary resuscitation was started. Secondary endpoints are the effectiveness of the technical and leadership instructions, respectively.
- Conditions
- Cardiopulmonary Resuscitations
- Being tested
- instruction
- Keywords
- Leadership, Team building, Resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instructionOther
Debriefing
| Study group | Role | What they receive |
|---|---|---|
| Technical | Active comparator | Technical Instructions Receives: Other: instruction |
| Leadership | Experimental | Leadership-Instructions Receives: Other: instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hands-on time in the first 180 seconds after the onset of the cardiac arrest and the time elapsed until cardiopulmonary resuscitation is started.
Measured: 180 sec after start of CPR
Secondary outcomes (1)
The effectiveness of the technical and leadership instructions
Measured: 180 sec after starting CPR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startNov 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabina Hunziker, MD, Principal investigator, University Hospital, Basel, SwitzerlandStephan Marsch, Prof, Study chair, Intensive Care unit, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884559
- Sponsor's protocol ID
- ekbb_SH_103
- Status last verified
- Aug 2012
- First submitted
- 17 Apr 2009
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00884559
- Acronym / sponsor ID
- ekbb_SH_103
- Conditions
- Cardiopulmonary Resuscitations
- Keywords
- Leadership, Team building, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Apr 2009 (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.
Whether teaching leadership with a short debriefing has a positive influence on the performance of cardiopulmonary resuscitation remains largely unknown. The investigators will assess the sustained efficacy of a short leadership debriefing compared to a technical debriefing in a high fidelity simulated cardiopulmonary resuscitation.
Detailed description
Context:
Whether the performance of cardiopulmonary resuscitation can be positively influenced by teaching leadership with a short debriefing remains largely unknown
Objective:
To test the hypothesis that (1) leadership instruction are effective and (2) improved leadership results in better performance in a high fidelity simulated cardiopulmonary resuscitation.
Design:
Prospective, randomized-controlled superiority trial
Setting:
Simulator Center of the University Hospital Basel in Switzerland
Patients or Other Participants:
237 volunteer medical students in teams of 3
Intervention:
During a baseline visit, the medical students participate in a video-taped simulated witnessed cardiac arrest. Participants are randomized to receive thereafter a short video-assisted debriefing focusing either on correct positions of arms and shoulders (technical debriefing) or on leadership and communication to enhance team coordination (leadership debriefing). A follow-up simulation is conducted after 4 months. Leadership utterances, technical skills and the resuscitation performance of the teams are compared based on videotapes coded by two independent researchers.
Main Outcome Measures:
The primary outcomes for this study are the amount of hands-on time in the first 180 seconds after the onset of the cardiac arrest and the time elapsed until cardiopulmonary resuscitation was started. Secondary endpoints are the effectiveness of the technical and leadership instructions, respectively.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technical | Active comparator | Other: instructionTechnical Instructions |
| Leadership | Experimental | Other: instructionLeadership-Instructions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- volunteer medical students
Key exclusion criteria (1 listed)
- no informed consent
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 |
|---|---|---|
| instructionDebriefing | Other | Leadership, Technical |
Primary outcome
Hands-on time in the first 180 seconds after the onset of the cardiac arrest and the time elapsed until cardiopulmonary resuscitation is started.
Time frame: 180 sec after start of CPR
1 secondary outcome
The effectiveness of the technical and leadership instructions
Time frame: 180 sec after starting CPR
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 27 Aug 2012.
Related trials for Cardiopulmonary Resuscitations
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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.
Sabina Hunziker, MD principal investigator
University Hospital, Basel, Switzerland
Stephan Marsch, Prof study chair
Intensive Care unit, University Hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing instruction in people with Cardiopulmonary Resuscitations, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 27 Aug 2012. 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 Switzerland. 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?
Hands-on time in the first 180 seconds after the onset of the cardiac arrest and the time elapsed until cardiopulmonary resuscitation is started. (time frame: 180 sec after start of CPR). 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 27 Aug 2012.