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

April 12, 2010 updated by: Children's Hospital of Philadelphia

"Feasibility of Ventilation Detection Using Thoracic Impedence Acquired Via Standard Defibrillator Electrode Pads in Mechanically Ventilated Pediatric Patients"

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Kathryn Roberts, MSN, RN, CRNP, CCRN, CCNS, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

April 14, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiration, Artificial

Subscribe