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

• Conditions: Pectus Excavatum

• Registration Number: NCT04046835
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-02
• Study Start: 2021-01
• Primary Completion: 2021-03
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient position	5 months	The effect of patient position on the value of the external Haller Index, based on 3D scans.

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Zuyderland Medical Centre; 🇳🇱 Heerlen, Limburg, Netherlands