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Clinical Trials/ACTRN12618001805268
ACTRN12618001805268
Recruiting
未知

The Physiological Changes Following Bronchoscopic Lung Volume Reduction Treatment for Chronic Obstructive Pulmonary Disease (COPD)

niversity of Adelaide0 sites50 target enrollmentNovember 6, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
niversity of Adelaide
Enrollment
50
Status
Recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 6, 2018
End Date
TBD
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
niversity of Adelaide

Eligibility Criteria

Inclusion Criteria

  • Established diagnosis of COPD with hyperinflation: post\-bronchodilator FEV1 \<50% of predicted AND TLC \> 100% AND RV\>175%
  • \- The absence of any collateral ventilation between target lobe and ipsilateral lobe, diagnosed with quantitative CT fissure integrity of \>90% and confirmation of integrity with Chartis measurement.
  • \- Age \>18 and \<75 at the time of enrolment.
  • \- 6\-min walk test distance \>150m following successful completion of a pulmonary rehabilitation program (or equivalent program).
  • \- No evidence of significant coexistent pulmonary pathology on HRCT
  • \- Able to safely undergo sedation or general anesthesia and bronchoscopy
  • \- Cessation of smoking for 3 months prior

Exclusion Criteria

  • Any patient deemed not suitable for EBV insertion based on internationally accepted best\-practice guidelines. Considerations include:
  • \- Significant co\-existent pulmonary pathology
  • \- Severe Hypercapnia (pCO2 \> 60mmHg on room air)
  • \- Unstable cardiovascular disease
  • \- Severe heart failure: EF \<35%
  • \- Unstable cardiac arrhythmia, myocardial infarction or stroke within 6 months
  • \- Severe PAH: RVSP \>45mmHg
  • \- Current Smoker
  • \- 6MWT distance less than 150m post pulmonary rehabilitation or equivalent program
  • \- FEV1 \<15% predicted

Outcomes

Primary Outcomes

Not specified

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