Sternal Wall Pressure in the Cath Lab
|ClinicalTrials.gov Identifier: NCT01117883|
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : July 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Perfusion Pressures Central Venous Pressure Cardiac Output CPR Cardiac Arrest||Other: Application of two different sternal weights||Not Applicable|
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.
- To characterize the effect of the application of two different weights on the sternum known to approximate "leaning" during CPR on central hemodynamic measurements and coronary perfusion pressures in mechanically ventilated children.
- To characterize the effect of the application of two different weights on the sternum known to approximate "leaning" during CPR on intrathoracic pressure in mechanically ventilated children STUDY DESIGN This protocol is a prospective interventional pilot study at the Children's Hospital of Philadelphia.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Gentle Sternal Chest Wall Pressure on Central Hemodynamic Measurements and Intrathoracic Pressure During Mechanical Ventilation in Children|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
- 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.
- The primary endpoint is the change in central hemodynamic measurements with application of two different sternal weights. [ Time Frame: 1 yr ]
- The secondary endpoint is the change in end-expiratory intrathoracic pressure with application of two different sternal weights. [ Time Frame: 1 yr ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117883
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Andy Glatz, MD||Children's Hospital of Philadelphia|