Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC)

Toulouse University Hospital

Status: Terminated

Conditions: Emphysema

Treatments: Device: Lung Volume Reduction Coil (HEAT-LVRC); Procedure: Bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02835001

RC31/15/7857

Details and patient eligibility

About

Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema

Full description

Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.

Enrollment: 20 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe emphysema (recent CT-scan (< 6 mois) )
• Age > 35 ans
• Modified Medical Research Council Scale (mMRC) > 2
• Forced expiratory volume in one second (FEV1) post-bronchodilatator < 45%
• Residual volume > 175%
• Total Pulmonary capacity > 100%

Exclusion criteria

• Forced expiratory volume in one second (FEV1) variability > 20% after bronchodilatator
• Carbon Monoxide Diffusing Capacity (TLCO) < 20%
• Recurrent respiratory infection Infections with clinics symptoms
• Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography > 50 mm Hg
• Impossibility to walk more that 140 meter (6 min test)
• Surgery history of volume reduction or pulmonary transplantation
• Broncho-dilatation with clinic symptoms

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Patient with severe emphysema

Other group

Description:

Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy

Treatment:

Procedure: Bronchoscopy

Device: Lung Volume Reduction Coil (HEAT-LVRC)