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

Pectus Excavatum Clinical Trial

— POSITION  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04046835
• Other study ID #: METCZ20190106
• Status: Not yet recruiting
• Start date: January 2021
• Est. completion date: April 2021

Study information

• Verified date: July 2020
• Source: Zuyderland Medisch Centrum
• Contact: Jean Daemen
• Phone: +31884597777
• Email: j.daemen[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: April 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Centre	Heerlen	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient position	The effect of patient position on the value of the external Haller Index, based on 3D scans.	5 months
Secondary	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)	5 months