Respiratory Muscle Function in COPD Exacerbations

NCT ID: NCT01869387

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-12-31

Brief Summary

There is evidence that noninvasive mechanical ventilation (NIV) is effective in the treatment of severe exacerbations of COPD presenting respiratory acidosis.

The aim of the study is to evaluate the benefit of adding NIV to conventional treatment in patients with COPD exacerbation and hypercapnic respiratory failure without acidosis requiring hospital admission. It is known that NIV improves respiratory mechanics, so the primary outcome will be respiratory muscle function.

All patients admitted to the hospital for COPD exacerbation and hypercapnic respiratory failure without acidosis will be included for a period of 12 months. The patients will be randomized into two groups (conventional treatment or conventional treatment plus NIV). Clinical data, blood gases, muscle strength parameters will be collected at the inclusion time and 24h after starting NIV. Quality of life and hospital stay will be measured at discharge. All patients will be followed for a year.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard treatment

Standard treatment consists in bronchodilator and parenteral corticosteroids and oxygen therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Standard treatment plus non-invasive ventilation

This arm consists in bronchodilator and parenteral corticosteroids and oxygen therapy plus non-invasive ventilation.

Group Type: EXPERIMENTAL

Non-invasive ventilation

Intervention Type: DEVICE

Interventions

Non-invasive ventilation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of COPD according to international guidelines ( GOLD)
• COPD exacerbation requiring hospitalization
• Initial blood gases: PaCO2> 50 mm Hg and pH> 7.35.
• If the patient does not have COPD diagnosis at the time of inclusion, it could be included if the diagnosis is confirmed within three months after the exacerbation.

Exclusion Criteria

• Patients with a pH below 7.35
• Patients with intubation criteria
• Other chronic respiratory diseases (fibrothorax, cystic fibrosis, significant ribcage alterations)
• Neuromuscular Diseases
• Significant associated chronic systemic diseases (severe liver disease, chronic renal failure requiring dialysis, severe heart disease and active neoplasia)
• COPD exacerbation secondary to pulmonary embolism, pneumonia or pneumothorax
• Patients in active treatment with CPAP or home ventilation

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital del Mar (Servei de Pneumología)

Barcelona, Barcelona, Spain

Countries

Spain

Central Contacts

Cristina Estirado, PhD

Role: CONTACT

97623@parcdesalutmar.cat

932483138

Facility Contacts

Cristina Estirado, PhD

Role: primary

97623@parcdesalutmar.cat

0034932483138

Other Identifiers

CRISOL-MARTINA-2013

Identifier Type: -

Identifier Source: org_study_id