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CompletedNCT00628407SWPUpdated Mar 11, 2011Results posted

Effects of Sternal Wall Pressure in Children

An observational study in Respiration, Artificial, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 6 Months to 7 Years. Per ClinicalTrials.gov, last updated 2011-03-11.

Sponsored by Children's Hospital of Philadelphia · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
13
Ages
6 Months to 7 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Respiration, Artificial

Keywords

  • leaning
  • CPR
  • sternal pressure
  • incomplete release
  • chest compressions
  • pediatric
03

In context

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 7 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Patients with contraindication to gentle, direct chest wall pressure (e.g. fresh sternotomy, recent chest wall surgery, chest tube in place)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
13 participants (actual)
06

What researchers measure

Primary outcomes

  1. Sternal Force Associated With Change in Intrathoracic Pressure.

    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.

    Time frame: per case

07

Results

Posted Mar 1, 2011

Participant flow

Potential subjects were screened from January 1, 2007-June 2, 2008 using the protocol inclusion and exclusion criteria. Any patient in the PICU (7 South or 7 East), Progressive Care Unit (PCU) and Operating Room (OR) settings involving stable but critically ill, mechanically ventilated children from 6 months to \< 8 years of age.

Participant flow — Overall Study
MilestoneSternal Wall Pressure
Started13
Completed13
Not completed0

Outcome measures

PrimarySternal Force Associated With Change in Intrathoracic Pressure.

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.

Time frame:
per case
Reported as:
Mean · kg
Sternal Force Associated With Change in Intrathoracic Pressure.
kgSternal Wall Pressure
Sternal Force Associated With Change in Intrathoracic Pressure.2.8 ± 0.9

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sternal Wall Pressure—0/13 (0%)0/13 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Sternal Wall Pressure
<=18 years13
Between 18 and 65 years0
>=65 years0
Age Continuous
Age Continuous(years)Sternal Wall Pressure
Mean2.2 ± 2
Sex: Female, Male
Sex: Female, Male(Participants)Sternal Wall Pressure
Female1
Male12
Region of Enrollment
Region of Enrollment(participants)Sternal Wall Pressure
United States13
08

Study locations

1 site
  • Children's Hospital of Philadelphia
    Phila, Pennsylvania 19104, United States
09

References and documents

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. doi: 10.1016/j.resuscitation.2010.03.015. Epub 2010 Apr 20. PubMed 20409628 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00628407
Lead sponsor
Children's Hospital of Philadelphia
Collaborators
Laerdal Medical
First posted
Mar 5, 2008
Start date
Jan 2007
Primary completion
Jul 2009
Completion
Dec 2009
Results posted
Mar 1, 2011
Last update
Mar 11, 2011

Study contacts

Vinay Nadkarni, MD
principal investigator · Children's Hospital of Philadelphia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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