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Status unknownNCT04046835POSITIONUpdated Jul 2, 2020

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

An observational study in Pectus Excavatum, sponsored by Zuyderland Medisch Centrum. Status unknown at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2020-07-02.

Sponsored by Zuyderland Medisch Centrum · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
12
Sex
All
01

Study 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.

02

Conditions studied

  • Pectus Excavatum

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Keywords

  • Three-dimensional optical surface scanning
  • Patient position
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
12 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Patient position

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

    Time frame: 5 months

Secondary outcomes

  1. Manual versus automatic alignment of patient position

    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)

    Time frame: 5 months

06

Study locations

1 site
  • Zuyderland Medical Centre
    Heerlen, Limburg 6419PC, Netherlands
07

Registry details

Key details

Study ID
NCT04046835
Lead sponsor
Zuyderland Medisch Centrum
Responsible party
Sponsor
First posted
Aug 6, 2019
Start date
Jan 2021 (estimated)
Primary completion
Mar 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Jul 2, 2020

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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