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CompletedNCT00628875Vent DetectionUpdated Apr 14, 2010

Feasibility of Ventilation Detection Via Standard Defibrillator Pads in Mechanically Ventilated Pediatric Patients

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 17 Years. Per ClinicalTrials.gov, last updated 2010-04-14.

Sponsored by Children's Hospital of Philadelphia · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
28
Ages
6 Months to 17 Years
Sex
All
01

Study 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.

Read the detailed description

Context: Resuscitation (CPR) guidelines recommend target values for rate and depth of rescue breathing and chest compressions. Defibrillator electrode pads can accurately detect the size, rate, and speed of machine-generated breaths in adults. The accuracy, precision, bias, and ability of the defibrillator electrode pads to detect the size, rate and speed of breathing in children have not been studied.

Objectives: The primary objective is to evaluate the accuracy, precision, bias and ability of the pads and defibrillator to detect the rate and depth of breathing in critically ill children on breathing machines. Important secondary objectives include reporting the accuracy, precision and bias of the measurement of the speed of the breath, measurement variability, and impact of alternative defibrillator electrode pad location on the chest.

Study Design/Setting/Participants:

Prospective, pilot, observational study in the Pediatric Intensive Care Unit and Progressive Care Unit at the Children's Hospital of Philadelphia. The participants are all patients in the PICU and Progressive Care Unit (PCU), 6 months to 17 years, who are supported by their clinical management team with a tracheal tube, standard breathing machine, and standard ICU monitoring systems.

Intervention:

Standard defibrillator electrode pads will be placed on the patient's chest in two typical pediatric configurations, and data will be recorded for 5 minutes in each configuration. These defibrillator electrode pads will be used exclusively for monitoring, as additions to the standard ICU monitoring.

Study Measures:

The primary outcome variable will be the successful detection of breathing rate. We will compare the accuracy, precision and bias of detection of each breath of > 2 ml/kg by the defibrillator electrode pads compared with the "gold standard" mechanical ventilator pneumotachometer detected breaths. Secondary outcome variables will include defibrillator electrode pad detection of breathing depth and speed compared to standard ICU monitors (considered the gold standard). We will also study the effect of defibrillator electrode pad location on the accuracy, precision, bias and ability to detect breathing rate, depth, and speed.

02

Conditions studied

  • Respiration, Artificial

Keywords

  • mechanical ventilation
  • thoracic impedence
  • defibrillator pads
  • ventilation detection
  • pediatric ventilation
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 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients with chest tubes
  2. High frequency ventilation (Jet or Oscillation)
  3. Airway Pressure Release ventilation
  4. Extracorporeal membrane oxygenation (ECMO)
  5. Significant chest wall abnormality (e.g. Vertebral Expandable Prosthetic Titanium Rib (VEPTR) or device precluding typical placement of defibrillator electrode pads)
  6. Altered skin integrity in areas where defibrillator electrode pads would be placed
05

Study design

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

What researchers measure

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.

    Time frame: 1 year

07

Study locations

1 site
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00628875
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
Last update
Apr 14, 2010

Study contacts

Kathryn Roberts, MSN, RN, CRNP, CCRN, CCNS
principal investigator · Children's Hospital of Philadelphia

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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