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

NCT04046835 | Unknown DMC

• 1 other identifier: METCZ20190106
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum

Keywords

Three-dimensional optical surface scanning; Patient position

Outcome Measures

Primary Outcomes (1)

• Patient position

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

  5 months

Secondary Outcomes (1)

• Manual versus automatic alignment of patient position

  5 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Centre

Heerlen, Limburg, 6419PC, Netherlands

Location

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Jean Daemen

CONTACT

+31884597777; j.daemen@zuyderland.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: January 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 2, 2020

Record last verified: 2020-07

Locations

NL (1)