N/A
N=13
Effects of Sternal Wall Pressure in Children
Respiration, Artificial
Bottom Line
View on ClinicalTrials.gov: NCT00628407 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Sternal Force Associated With Change in Intrathoracic Pressure. — 2.8 kg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sternal Force Associated With Change in Intrathoracic Pressure. |
2.8 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00628407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.