Effects of Sternal Wall Pressure in Children (SWP)

This study has been completed.
Sponsor:
Collaborator:
Laerdal Medical
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00628407
First received: February 26, 2008
Last updated: March 9, 2011
Last verified: March 2011
  Purpose

This protocol is a prospective, pilot, observational study in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and the Operating Room (OR) settings at the Children's Hospital of Philadelphia (CHOP). We propose to observe, measure and report the effect of incremental gentle sternal pressure increases on intrathoracic pressure, and other surrogates of hemodynamic function, in stable mechanically ventilated children. This study will provide preliminary data to inform the resuscitation research community and assist development of evidence-based pediatric resuscitation guidelines in the future.


Condition
Respiration, Artificial

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Gentle Sternal Chest Wall Pressure on Intrathoracic Pressure During Mechanical Ventilation in Children.

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Sternal Force Associated With Change in Intrathoracic Pressure. [ Time Frame: per case ] [ Designated as safety issue: No ]
    The mean sternal force (measured in kg as a surrogate for Newtons [1kg = 9.81 newtons]) associated with a ≥2cm H2O peak endotracheal pressure (ETP) change.


Enrollment: 13
Study Start Date: January 2007
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Context: Survival outcome following cardiac arrest in children is poor, and recent evidence suggests that the quality of Cardiopulmonary Resuscitation(CPR) is critically important. Venous blood return to the thorax to refill the heart is essential for good quality CPR and critical organ perfusion. Adult cardiac arrest studies suggest that incomplete chest wall decompression (i.e. "leaning" on the sternum of the chest) during CPR affects intrathoracic pressure and impedes venous return. The consequence of "leaning" on the chest during CPR is increased intrathoracic pressure, which creates a "back-pressure" preventing optimal return of blood to the heart. The critical importance of manipulating positive and negative intrathoracic pressures during Cardiopulmonary Resuscitation (CPR) has been recently demonstrated in both animal and human studies. Food and Drug Administration (FDA) approved defibrillators with a force and depth sensor can monitor the depth, rate and complete release of sternal pressure during CPR. These FDA approved defibrillators have been introduced and implemented in the Pediatric Intensive Care Unit (PICU) at the Children's Hospital of Philadelphia (CHOP). These defibrillators can provide feedback on the force and amount of "leaning", but there is no data on the minimal amount of sternal pressure (or "leaning pressure") that affects intrathoracic or intravascular pressures or venous return to the heart. In addition, there is no data on how much force on the sternal pressure sensor (e.g. leaning on the sensor) begins to affect intrathoracic pressure in children. We propose to observe, measure and report the effect of incremental gentle sternal pressure increases on intrathoracic pressure, and other surrogates of hemodynamic function, in stable but critically ill and mechanically ventilated children. This study will provide preliminary data to inform the resuscitation research community and assist development of evidence-based pediatric resuscitation guidelines in the future.

Objectives: 1) To characterize the effect of gentle, incremental increases in sternal chest pressure on intrathoracic pressure in mechanically ventilated children. 2) To characterize the effect of gentle, incremental increases in sternal pressure on regional perfusion pressures, when existing catheters (arterial, central venous, intracranial) are present.

Study Design/Setting/Participants: This protocol is a prospective, pilot, observational study in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and the Operating Room (OR)settings at the Children's Hospital of Philadelphia. The participants are a convenience sample of stable mechanically ventilated children from 6 months to < 8 years of age. A total of 20 patients will be enrolled, including a minimum of 10 with vascular catheters.

Study Measures: The primary outcome variable is the change in intrathoracic pressure with incremental increase in gentle sternal pressure, measured by the peak airway pressure detected at the proximal end of the tracheal tube during end inspiration. Secondary outcomes include additional measures of intrathoracic pressure (end inspiratory pressure, mean pressure, area under the curve over 15 seconds, plateau pressure). For patients with indwelling central venous, arterial or intracranial pressure monitors, perfusion pressure changes will also be analyzed.

  Eligibility

Ages Eligible for Study:   6 Months to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and Operating Room (OR) settings involving stable, mechanically ventilated children in the Children's Hospital of Philadelphia.

Criteria

Inclusion Criteria:

  • Age 6 months to < 8 years.
  • Weight greater than 4.8 kg.
  • Hemodynamically stable (defined by the Pediatric Critical Care Team, Anesthesiologists and Surgeons)
  • Volume Limited Ventilation Mode on Conventional Mechanical Ventilator
  • Vascular catheters in place (for at least 10 subjects)
  • Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

  • Patients with contraindication to gentle, direct chest wall pressure (e.g. fresh sternotomy, recent chest wall surgery, chest tube in place)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628407

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Phila, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Laerdal Medical
Investigators
Principal Investigator: Vinay Nadkarni, MD Children's Hospital of Philadelphia
  More Information

Publications:
Sutton RM, Niles D, Nysaether J, Stavland M, Thomas M, Ferry S, Bishnoi R, Litman R, Allen J, Srinivasan V, Berg RA, Nadkarni VM. Effect of residual leaning force on intrathoracic pressure during mechanical ventilation in children. Resuscitation. 2010 Jul;81(7):857-60. Epub 2010 Apr 20.

Responsible Party: Vinay Nadkarni, MD, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00628407     History of Changes
Other Study ID Numbers: 2006-10-5023
Study First Received: February 26, 2008
Results First Received: November 18, 2010
Last Updated: March 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
leaning
CPR
sternal pressure
incomplete release
chest compressions
pediatric

ClinicalTrials.gov processed this record on October 23, 2014