- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00884559
Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation
Brief Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation: a Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Basel, Switzerland
- University Hospital Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- volunteer medical students
Exclusion Criteria:
- no informed consent
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Technical
Technical Instructions
|
Debriefing
|
|
Experimental: Leadership
Leadership-Instructions
|
Debriefing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
180 sec after start of CPR
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The effectiveness of the technical and leadership instructions
Time Frame: 180 sec after starting CPR
|
180 sec after starting CPR
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sabina Hunziker, MD, University Hospital, Basel, Switzerland
- Study Chair: Stephan Marsch, Prof, Intensive Care unit, University Hospital Basel, Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ekbb_SH_103
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