NCT00628875

Brief Summary

This study is a prospective, observational case series of a convenience sample of mechanically ventilated pediatric patients in the Pediatric ICU, Progressive Care Unit and Operating Room at the Children's Hospital of Philadelphia. We propose to observe, measure and report the accuracy, precision and bias of defibrillator electrode pads to detect breathing 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 14, 2010

Status Verified

April 1, 2010

Enrollment Period

2.5 years

First QC Date

February 26, 2008

Last Update Submit

April 12, 2010

Conditions

Keywords

mechanical ventilationthoracic impedencedefibrillator padsventilation detectionpediatric ventilation

Outcome Measures

Primary Outcomes (1)

  • This is a pilot study to gather preliminary data. The primary endpoint is the accuracy of defibrillator pad detection of breaths >2ml/kg, compared to the gold standard pneumotachometer detection of breaths.

    1 year

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients admitted to the Pediatric Intensive care Unit, Progressive Care Unit or Operating Room at the Children's Hospital of Philadelphia

You may qualify if:

  • Patients age 6 months - 17 years with:
  • Artificial airway
  • Mechanical ventilation (PCV or VCV)
  • Hemodynamic stability to participate in the study, as determined by the clinical treatment team.
  • Parental/guardian permission (informed consent) and if appropriate, child assent.

You may not qualify if:

  • Patients with chest tubes
  • High frequency ventilation (Jet or Oscillation)
  • Airway Pressure Release ventilation
  • Extracorporeal membrane oxygenation (ECMO)
  • Significant chest wall abnormality (e.g. Vertebral Expandable Prosthetic Titanium Rib (VEPTR) or device precluding typical placement of defibrillator electrode pads)
  • Altered skin integrity in areas where defibrillator electrode pads would be placed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kathryn Roberts, MSN, RN, CRNP, CCRN, CCNS

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 5, 2008

Study Start

January 1, 2007

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

April 14, 2010

Record last verified: 2010-04

Locations