Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure

Emphysema Clinical Trial

Official title:

Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02996149
• Other study ID #: PV-5379
• Status: Terminated
• Start date: November 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) < 50% predicted and residual volume (RV) = 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed

• Chronic hypercapnic respiratory failure (PaCO2 = 50 mmHg)

• Informed consent

Exclusion Criteria:

• Therapeutic anticoagulation

• Anti-platelet therapy exceeding the use of acetylsalicylic acid

• Severe pulmonary hypertension

Related Conditions & MeSH terms

• Emphysema
• Respiratory Insufficiency

Intervention

Procedure:
• Endoscopic lung volume reduction coil treatment

Locations

Country	Name	City	State
Germany	University Hospital Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in PaCO2		3 months after endoscopic lung volume reduction (ELVR)
Secondary	Changes in PaCO2		6 and 12 months after ELVR
Secondary	Changes in FEV1		3, 6 and 12 months after ELVR
Secondary	Changes in vital capacity		3, 6 and 12 months after ELVR
Secondary	Changes in residual volume		3, 6 and 12 months after ELVR
Secondary	Changes in 6-minute walk distance		3, 6 and 12 months after ELVR
Secondary	Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ)		3, 6 and 12 months after ELVR
Secondary	Changes in BMI		3, 6 and 12 months after ELVR