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Effects of Sternal Wall Pressure in Children (SWP)

9. mars 2011 oppdatert av: Children's Hospital of Philadelphia

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.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

13

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Pennsylvania
      • Phila, Pennsylvania, Forente stater, 19104
        • Children's Hospital of Philadelphia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 måneder til 7 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sternal Force Associated With Change in Intrathoracic Pressure.
Tidsramme: per case
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.
per case

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Vinay Nadkarni, MD, Children's Hospital of Philadelphia

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2007

Primær fullføring (Faktiske)

1. juli 2009

Studiet fullført (Faktiske)

1. desember 2009

Datoer for studieregistrering

Først innsendt

26. februar 2008

Først innsendt som oppfylte QC-kriteriene

4. mars 2008

Først lagt ut (Anslag)

5. mars 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. mars 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. mars 2011

Sist bekreftet

1. mars 2011

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2006-10-5023

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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