Sternal Wall Pressure in the Cath Lab
| Tracking Information | |||||
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| First Received Date ICMJE | May 4, 2010 | ||||
| Last Updated Date | July 13, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary endpoint is the change in central hemodynamic measurements with application of two different sternal weights. [ Time Frame: 1 yr ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01117883 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The secondary endpoint is the change in end-expiratory intrathoracic pressure with application of two different sternal weights. [ Time Frame: 1 yr ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sternal Wall Pressure in the Cath Lab | ||||
| Official Title ICMJE | Effect of Gentle Sternal Chest Wall Pressure on Central Hemodynamic Measurements and Intrathoracic Pressure During Mechanical Ventilation in Children | ||||
| Brief Summary | This protocol is a prospective interventional pilot study at the Children's Hospital of Philadelphia to determine whether or not two increments of sternal pressure known to occur during "leaning" in CPR affects hemodynamic function, coronary perfusion pressures, and intrathoracic pressure in order to inform the resuscitation community on reasonable target pressures to avoid "leaning" on the chest during pediatric CPR. |
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| Detailed Description | STUDY RATIONALE The critical importance of positive and negative intrathoracic pressures during Cardiopulmonary Resuscitation (CPR) has been recently demonstrated. During CPR, excessive positive intrathoracic pressure caused by overzealous ventilation or incomplete chest wall decompression has a detrimental effect on venous return to the heart, cardiac hemodynamics, and survival in adults. FDA-approved monitor/defibrillators with sensors that detect and provide feedback on the quality of chest compressions, including the amount of sternal pressure ("leaning"), can improve the quality of CPR in adults. These monitor/defibrillators have recently been implemented in the PICU and ED at CHOP. However, determining whether "leaning" (or gentle sternal pressure) affects return of venous blood to the thorax and intrathoracic pressure in children is unknown. A pilot study to determine whether or not two increments of sternal pressure known to occur during "leaning" in CPR affects hemodynamic function, coronary perfusion pressures, and intrathoracic pressure would be a first step toward informing the resuscitation community on reasonable target pressures to avoid "leaning" on the chest during pediatric CPR. STUDY OBJECTIVE(S)
STUDY PHASES Screening: Prospective patients enrolled will be screened by a co-investigator. Those that meet inclusion criteria will be approached by a member of the investigative team during the routine pre-procedure evaluation in the Cardiac Intake Center for discussion of the study and informed consent. Phase 1: We will measure the depth of the chest. We will measure central hemodynamic pressures and function, coronary perfusion pressures and intrathoracic pressures as two weights (10% and 20% of body weight) are placed on the sternum. The primary outcome variable will be the change in any of the central hemodynamic measurements before and after each weight is applied to the sternum. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Application of two different sternal weights
Two separate weights (first 10% of body weight, then 20% of body weight) will be placed on the sternum and changes in central hemodynamic measurements and intrathoracic pressure will be recorded and documented. |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | March 2011 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Months to 7 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01117883 | ||||
| Other Study ID Numbers ICMJE | 09-007428 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Andrew Galtz, MD, Children's Hospital of Philadelphia | ||||
| Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||
| Collaborators ICMJE | Laerdal Foundation for Acute Care Medicine | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Philadelphia | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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