DLco Data Capture

Quality Assured DLco Data in your Centralized Respiratory Dataset

Assessing the diffusing capacity of the lungs for carbon monoxide (DLco) is one of the most clinically valuable tests of lung function and a commonly used endpoint in respiratory clinical trials. The Vitalograph® DLco solution enables reports from sites’ own equipment to be uploaded to the COMPACT™ Medical Workstation for inclusion alongside other study data, in a centralized respiratory data set. This approach minimises study device rental costs and equipment storage for sites.

DLco reports are manually uploaded to the COMPACT Medical Workstation by qualified site staff and sent to a central Vitalograph database. For quality assurance, Vitalograph clinical specialists over-read DLco data, providing accessible results and feedback to continuously improve site data, compliance and performance throughout the study.

  • Centralized respiratory dataset to simplify data management.
  • No additional cost incurred for rental of DLco equipment where a site’s own DLco equipment is used.
  • All training, support and equipment required for upload are provided by Vitalograph.
  • Expert over-reading service for quality assured data.
  • Accessible data for site and sponsor monitoring.
  • Key opinion leaders (KOLs) on hand to advise and support with study design.

Technical Specification

 

Vitalograph COMPACT
Model Number6600
Dimensions375mm x 235mm x 110mm
WeightNet: 2.5kg
CommunicationsUSB x minimum 6, Serial x 2, Ethernet x 2, DVI, WiFi
QA/GMP StandardsISO 13485, FDA 21 CFR 820, SOR/98-282, JPAL, MDSAP
Voltage/Frequency110-240 V; approximately 50/60 Hz
Performance Standards/Guidelines met or exceeded by the Vitalograph COMPACT ExpertISO 23747, ISO 26782, ATS/ERS 2019
Spirometry Specifications
Flow detection principleFleisch type pneumotacograph
Back pressureLess than 0.1kPa/L/second @ 14L/s, complies with ISO26782:2009
Volume accuracy±2.5% or 0.05L
Flow accuracyFlow ±10% or 0.3 L/s