Cardiac Arrest Clinical Trial
Official title:
Effect of Gentle Sternal Chest Wall Pressure on Central Hemodynamic Measurements and Intrathoracic Pressure During Mechanical Ventilation in Children
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.
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)
- 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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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