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POSITION: The Effect of Patient Position on the External Haller Index Value Among Patients With Pectus Excavatum

Sponsor
Zuyderland Medisch Centrum (Other)
Overall Status
Unknown status
CT.gov ID
NCT04046835
Collaborator
(none)
12
Enrollment
1
Location
3
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pectus excavatum is the most common anterior chest wall deformity, affecting up to 1:400 of newborns. The current gold standard to quantify the extent of deformity is by calculating the Haller Index based on a Computed Tomography (CT)-scan. However, as such scans inescapably imply exposure to ionizing radiation, novel imaging techniques have been investigated. Three-dimensional optical surface scanning is a promising new technique to acquire the trunks' three-dimensional (3D) surface topography. Based on this 3D scan, one is able to calculate the external Haller Index that is known to highly correlate with the conventional gold standard Haller Index that is based on internal measures. Both the conventional and external Haller Index are known to be affected by the respiratory phase in which the scan is acquired, however, what is the effect of patient position on the external Haller Index, and if affected, how should one correct for this phenomenon? To investigate this, a retrospective single-centre pilot study will be conducted.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    12 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Effect of Patient Position on the External Haller Index Value Among Patients With Pectus Excavatum
    Anticipated Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2021
    Anticipated Study Completion Date :
    Apr 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Patient position [5 months]

      The effect of patient position on the value of the external Haller Index, based on 3D scans.

    Secondary Outcome Measures

    1. Manual versus automatic alignment of patient position [5 months]

      If there is a significant effect of patient position on the external Haller Index, the ideal correction method is investigated (manual alignment versus automatic, computer-based alignment)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients that received a three-dimensional optical surface scan to quantify their pectus deformity
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zuyderland Medical Centre Heerlen Limburg Netherlands 6419PC

    Sponsors and Collaborators

    • Zuyderland Medisch Centrum

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zuyderland Medisch Centrum
    ClinicalTrials.gov Identifier:
    NCT04046835
    Other Study ID Numbers:
    • METCZ20190106
    First Posted:
    Aug 6, 2019
    Last Update Posted:
    Jul 2, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zuyderland Medisch Centrum
    Three-dimensional optical surface scanning
    Patient position
    Additional relevant MeSH terms:
    Funnel Chest

    Study Results

    No Results Posted as of Jul 2, 2020