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Clinical Trials/NCT04046835
NCT04046835UnknownNot Applicable

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

Zuyderland Medisch Centrum1 site in 1 country12 target enrollmentStarted: January 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
Patient position

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patient position

Time Frame: 5 months

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

Secondary Outcomes

  • Manual versus automatic alignment of patient position(5 months)

Investigators

Sponsor
Zuyderland Medisch Centrum
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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