Skip to content

Effects of Sternal Wall Pressure in Children

Effect of Gentle Sternal Chest Wall Pressure on Intrathoracic Pressure During Mechanical Ventilation in Children.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00628407
Acronym
SWP
Enrollment
13
Registered
2008-03-05
Start date
2007-01-31
Completion date
2009-12-31
Last updated
2011-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration, Artificial

Keywords

leaning, CPR, sternal pressure, incomplete release, chest compressions, pediatric

Brief 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.

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.

Interventions

None listed

Sponsors

Laerdal Medical
CollaboratorINDUSTRY
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 7 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Sternal Force Associated With Change in Intrathoracic Pressure.per caseThe 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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Sternal Wall Pressure13
Total13

Baseline characteristics

CharacteristicSternal Wall Pressure
Age, Categorical
<=18 years
13 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age Continuous2.2 years
STANDARD_DEVIATION 2
Region of Enrollment
United States
13 participants
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 13
serious
Total, serious adverse events
0 / 13

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Sternal Wall PressureSternal Force Associated With Change in Intrathoracic Pressure.2.8 kgStandard Deviation 0.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026