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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046835
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Zuyderland Medisch Centrum

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
Pectus Excavatum

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Study Type : Observational
Estimated 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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021



Primary Outcome Measures :
  1. Patient position [ Time Frame: 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 [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients that received a three-dimensional optical surface scan to quatify their pectus deformity utilizing the external Haller Index. Patients were retrospectively recruited from the 3DPECTUS study (METCZ20190048; NCT03926078).
Criteria

Inclusion Criteria:

  • Patients that received a three-dimensional optical surface scan to quantify their pectus deformity

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046835


Contacts
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Contact: Jean Daemen +31884597777 j.daemen@zuyderland.nl

Locations
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Netherlands
Zuyderland Medical Centre
Heerlen, Limburg, Netherlands, 6419PC
Sponsors and Collaborators
Zuyderland Medisch Centrum
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Responsible Party: Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier: NCT04046835    
Other Study ID Numbers: METCZ20190106
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020

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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:
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Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities