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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 th
Sponsor: Johns Hopkins All Children's Hospital

Current Primary Outcome:

  • Sensitivity of clinically-derived threshold versus CT/MRI-derived thresholds [ Time Frame: 5 years ]
    Sensitivity refers to the ability of the test to correctly identify those patients with the disease.
  • Specificity of clinically-derived threshold versus CT/MRI-derived thresholds [ Time Frame: 5 years ]
    Specificity refers to the ability of the test to correctly identify those patients without the disease.
  • Receiver operator characteristic curve of clinically-derived threshold versus CT/MRI-derived thresholds [ Time Frame: 5 years ]


Original Primary Outcome:

  • Sensitivity of clinically-derived threshold versus CT/MRI-derived thresholds [ Time Frame: 5 years ]
  • Specificity of clinically-derived threshold versus CT/MRI-derived thresholds [ Time Frame: 5 years ]
  • Receiver operator characteristic curve of clinically-derived threshold versus CT/MRI-derived thresholds [ Time Frame: 5 years ]


Current Secondary Outcome:

  • Correlation coefficient [ Time Frame: 5 years ]
  • Cohen's Kappa coefficient [ Time Frame: 5 years ]
  • Agreement between Clinical Pectus Index (CPI) and Pectus Index (PI)-derived from CT or MRI [ Time Frame: 5 years ]


Original Secondary Outcome: Same as current

Information By: Johns Hopkins All Children's Hospital

Dates:
Date Received: September 15, 2015
Date Started: September 2015
Date Completion: September 2020
Last Updated: December 1, 2016
Last Verified: December 2016