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Sponsors and Collaborators: |
Children's Hospital of Philadelphia Laerdal Medical |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00628875 |
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.
Condition |
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Respiration, Artificial |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | "Feasibility of Ventilation Detection Using Thoracic Impedence Acquired Via Standard Defibrillator Electrode Pads in Mechanically Ventilated Pediatric Patients" |
Estimated Enrollment: | 60 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 6 Months to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Pediatric patients admitted to the Pediatric Intensive care Unit, Progressive Care Unit or Operating Room at the Children's Hospital of Philadelphia
Inclusion Criteria:
Exclusion Criteria:
Contact: Dana Niles, MS | 215-590-4039 | niles@email.chop.edu |
Contact: Kathryn Roberts, MSN | (215)590-3418 | robertsk@email.chop.edu |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Dana Niles, MS 215-590-4039 niles@email.chop.edu | |
Sub-Investigator: Vinay Nadkarni, MD | |
Sub-Investigator: Vijay Srinivasan, MD | |
Sub-Investigator: Lisa Tyler, RT | |
Sub-Investigator: Lori Boyle, RN |
Principal Investigator: | Kathryn Roberts, MSN, RN, CRNP, CCRN, CCNS | Children's Hospital of Philadelphia |
Responsible Party: | Children's Hospital of Philadelphia ( Kathryn Roberts ) |
Study ID Numbers: | 2006-10-5022 |
Study First Received: | February 26, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00628875 |
Health Authority: | United States: Institutional Review Board |
mechanical ventilation thoracic impedence defibrillator pads ventilation detection pediatric ventilation |