Non-invasive Clinical Pectus Index as a Measurement of Severity in Pectus



Status:Recruiting
Healthy:No
Age Range:11 - 21
Updated:1/18/2019
Start Date:September 2015
End Date:September 2020
Contact:JoAnn DeRosa, RN
Email:joann.derosa@jhmi.edu
Phone:7277672941

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Pectus excavatum (PE), the most common congenital chest wall deformity, requires surgical
repair when the degree of deformity is severe. Currently, the Pectus Index (PI) is used to
classify PE severity. Calculation of the PI requires cross-sectional imaging of the chest,
usually with computed tomography (CT) or Magnetic Resonance Imaging (MRI), to obtain the
necessary measurements. However, CT delivers a high dose of ionizing radiation, which carries
cumulative long-term risks of malignancy and MRI can be costly. The purpose of this study is
to develop a method whereby accurate chest wall measurements can be obtained to quantify PE
severity without the need for cross-sectional imaging.

This is a prospective study. The study population will consist of 2 groups. The first group
(PE Group) will consist of patients presenting to the Johns Hopkins All Children's Hospital
(JHACH) Pediatric Surgery or Cardiac Surgery Clinics and the outpatient clinic system at
Johns Hopkins Hospital for evaluation of pectus excavatum. The second group (Control Group)
will be age and gender matched patients presenting to the Radiology department of JHACH
undergoing CT chest for indications other than chest wall deformity. Clinical caliper
measurements will be taken and used to calculate the Clinical PI.

The steps to obtain the clinical caliper measurements are as follows: With the subject lying
down, a ruler will be placed across the chest and a second ruler will be used to measure the
depth at the deepest point of the sternum. The 2nd ruler will then be used to measure the
height of the horizontal ruler to the bed on both sides. All measurements will be made on end
expiration. With the subject standing, a measuring tape will be placed around the chest at
the point of the deepest sternal depression. The sternum, spine and the bilateral lateral
chest locations will be marked with temporary ink. The tape will be kept as level as
possible. Chest calipers will be used to measure from deepest point of sternum to posterior
midline, posterior midline to anterior chest and the transverse chest diameter. Each
measurement will be taken at end expiration. The circumference of the chest will be recorded.

Each set of measurements will be taken by 2 independent members of the research team.
Attempts will be made to record the amount of time it takes to obtain the measurements.
Consent will be obtained to photograph the process for illustrative purposes. Every attempt
will be made to conceal the patient's identity by excluding the face from the photograph. In
instances where the face is not able to be excluded, the facial features will be blurred.

Clinical measurements may be recorded during routine medical care at the provider's
discretion. However, these measurements will be considered research procedures for the
purposes of this trial. A copy of the measurements will be placed in the medical chart of
subjects evaluated for PE for the provider's future reference. Measurements obtained in the
Control group will be strictly for the purposes of the research protocol. All subjects,
regardless of group, will be provided standard of care for all other medical conditions.

All CT and MRI performed for both PE and Control groups will be reviewed and the PI will be
determined by a single, blinded radiologist. The radiologist determining the PI may not be
the interpreting radiologist and will have no responsibility to provide a comprehensive
interpretation of the study. The PI as determined by the research radiologist will be
recorded separately from the subject's EMR in a research file. Having a single, blinded
radiologist determine the PI for the entire research cohort will allow for consistency in
determining the PI, as this is the gold standard to which we are comparing our clinical
measurements.

Inclusion Criteria:

- Group A (PE Group): All patients evaluated in the ACH JHM Pediatric Surgery or Cardiac
Surgery Clinics, as well as in the outpatient clinic system at Johns Hopkins Hospital,
for surgical correction of Pectus Excavatum.

- Group B (Control Group): Age and gender matched patients who undergo chest CT at the
ACH JHM Radiology Department for indications other than Pectus Excavatum.

Exclusion Criteria:
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Saint Petersburg, Florida 33701
Phone: 727-767-2941
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