Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema

NCT03034421 | Terminated

• 1 other identifier: Protocol G1.1 - 17.04.2016
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after valve implantation may reduce the risk of post-interventional pneumothorax.

Conditions

Pneumothorax

Outcome Measures

Primary Outcomes (1)

• Advent of pneumothorax within 90 days following valve implantation

  Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.

  90 days following valve implantation

Secondary Outcomes (3)

• Lung function before and after valve therapy

  30 and 90 days following valve implantation

• Excercise capacity before and after valve therapy

  30 and 90 days following valve implantation

• Dyspnoe score before and after valve therapy

  30 and 90 days following valve implantation

Study Arms (2)

Modified medical care

ACTIVE COMPARATOR

Patients will undergo 48-hours bed rest after endoscopic valve implantation.

Behavioral: Bed rest

Standard medical care

NO INTERVENTION

Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation.

Interventions

Bed rest BEHAVIORAL

Patients will undergo bed rest for 48 hours following endoscopic valve implantation.

Modified medical care

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FEV1 \< 50%, RV\>150%, TLC\>100%
• emphysema confirmed by computed tomography
• pO2 \>60 mmHg (with supplemental oxygen), pCO2 \< 55 mmHg (room condition)
• no significant collateral ventilation (assessed by fissure analysis and/or catheter-based measurement)
• no COPD exacerbation within the past 8 weeks
• daily use of \< 20 mg Prednisolon
• non-smoking for a minimum of 4 months prior to consent
• Patient has provided written informed consent

You may not qualify if:

• BMI \< 18 kg/m²
• clinically relevant bronchiectasis
• failed cardiac clearance: defined as myocardial infarction within last 6 weeks, decompensation of heart failure
• Prior lung resection (e.g. lobectomy)

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

Location

MeSH Terms

Conditions

Pneumothorax

Interventions

Bed Rest

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Daniela Gompelmann, MD

  Thoraxklinik at University of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: January 27, 2017
• Study Start: September 1, 2016
• Primary Completion: August 30, 2018
• Study Completion: September 30, 2018
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

DE (1)