COPD Breathing Record Study 2

NCT03615365 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-06-02

No results posted yet for this study

Summary

The aim of this study is to collect capnometric (tidal breathing CO2) data using TidalSense's N-Tidal C Data Collector Device. The data collected will be examined for correlation with currently accepted assessment techniques for COPD (spirometry, vital signs and pulse oximetry) and the patient's clinical condition (stable, worsening, improving). The patient numbers and study duration have been determined by power calculations to provide a statistically significant sample size, based on expected number of exacerbations (mild, moderate and severe) from the patient cohort. The data will also be examined to assess the predictive possibility of a non-invasive self-care personal CO2 monitoring device to identify COPD exacerbations.

Conditions

Sponsors & Collaborators

  • TidalSense

    lead INDUSTRY

Principal Investigators

  • Ravi Mahadeva · Cambridge University Hospitals NHS Foundation Trust

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2018-10-18
Completion
2018-11-23

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03615365 on ClinicalTrials.gov