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

Primary Purpose

Pectus Excavatum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caliper measurement
Sponsored by
Johns Hopkins All Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pectus Excavatum

Eligibility Criteria

11 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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:

  • None

Sites / Locations

  • Johns Hopkins All Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pectus Excavatum Group

Control Group

Arm Description

The first group (PE Group) will consist of patients presenting to the All Children's Hospital Johns Hopkins Medicine (ACH JHM) Pediatric Surgery or Cardiac Surgery Clinics and the outpatient clinic system at Johns Hopkins Hospital for evaluation of pectus excavatum. Clinical measurements will be obtained using calipers.

The second group (Control Group) will be age and gender matched patients presenting to the Radiology department of ACH JHM undergoing CT chest for indications other than chest wall deformity.

Outcomes

Primary Outcome Measures

Sensitivity of clinically-derived threshold versus CT/MRI-derived thresholds
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
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
plot of the true positive rate against the false positive rate for the different possible cutpoints of a diagnostic test.

Secondary Outcome Measures

Correlation coefficient
statistical measure of the strength of the relationship between the relative movements of two variables.
Cohen's Kappa coefficient
a statistic which measures inter-rater agreement for qualitative (categorical) items. It
Agreement between Clinical Pectus Index (CPI) and Pectus Index (PI)-derived from CT or MRI
determine how well each measure identifies the outcome desired

Full Information

First Posted
September 15, 2015
Last Updated
June 28, 2023
Sponsor
Johns Hopkins All Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02552186
Brief Title
Non-invasive Clinical Pectus Index as a Measurement of Severity in Pectus
Official Title
Non-invasive Clinical Pectus Index as a Measurement of Severity in Pectus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins All Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pectus Excavatum Group
Arm Type
Active Comparator
Arm Description
The first group (PE Group) will consist of patients presenting to the All Children's Hospital Johns Hopkins Medicine (ACH JHM) Pediatric Surgery or Cardiac Surgery Clinics and the outpatient clinic system at Johns Hopkins Hospital for evaluation of pectus excavatum. Clinical measurements will be obtained using calipers.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The second group (Control Group) will be age and gender matched patients presenting to the Radiology department of ACH JHM undergoing CT chest for indications other than chest wall deformity.
Intervention Type
Other
Intervention Name(s)
Caliper measurement
Intervention Description
Clinical caliper measurements will be taken and used to calculate the Clinical PI
Primary Outcome Measure Information:
Title
Sensitivity of clinically-derived threshold versus CT/MRI-derived thresholds
Description
Sensitivity refers to the ability of the test to correctly identify those patients with the disease.
Time Frame
5 years
Title
Specificity of clinically-derived threshold versus CT/MRI-derived thresholds
Description
Specificity refers to the ability of the test to correctly identify those patients without the disease.
Time Frame
5 years
Title
Receiver operator characteristic curve of clinically-derived threshold versus CT/MRI-derived thresholds
Description
plot of the true positive rate against the false positive rate for the different possible cutpoints of a diagnostic test.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Correlation coefficient
Description
statistical measure of the strength of the relationship between the relative movements of two variables.
Time Frame
5 years
Title
Cohen's Kappa coefficient
Description
a statistic which measures inter-rater agreement for qualitative (categorical) items. It
Time Frame
5 years
Title
Agreement between Clinical Pectus Index (CPI) and Pectus Index (PI)-derived from CT or MRI
Description
determine how well each measure identifies the outcome desired
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Chandler, MD
Organizational Affiliation
JHACH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States

12. IPD Sharing Statement

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

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