Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 26, 2008
March 9, 2011
January 2007
July 2009   (final data collection date for primary outcome measure)
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.
The primary endpoint is the change in end-expiratory inspiratory intrathoracic pressure averaged over 5 breaths. [ Time Frame: per case ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00628407 on ClinicalTrials.gov Archive Site
Not Provided
• Minimum sternal leaning pressure resulting in a pressure change (averaged over 5 breaths) in: a) intrathoracic pressure of 3cmH2O, or b) central venous pressure of 3 mmHg (if monitor exists) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Sternal Wall Pressure in Children
Effect of Gentle Sternal Chest Wall Pressure on Intrathoracic Pressure During Mechanical Ventilation in Children.

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Respiration, Artificial
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2009
July 2009   (final data collection date for primary outcome measure)

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)
Both
6 Months to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00628407
2006-10-5023
No
Vinay Nadkarni, MD, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Laerdal Medical
Principal Investigator: Vinay Nadkarni, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP