Respiratory Muscle Function in COPD Exacerbations

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Device: Non-invasive ventilation

• Registration Number: NCT01869387
• Lead Sponsor: Parc de Salut Mar

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-31
• Last Update Submitted: 2013-05-31
• Study Start: 2013-06
• Study First Posted: 2013-06-05
• Last Update Posted: 2013-06-05
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment plus non-invasive ventilation	Non-invasive ventilation	This arm consists in bronchodilator and parenteral corticosteroids and oxygen therapy plus non-invasive ventilation.

Primary Outcome Measures

Name	Time	Method
Respiratory muscle function.	At baseline, at discharge (average of 8 days), 6 months and one year later.	Measurement of maximal inspiratory pressure and sniff nasal inspiratory pressure using a portable respiratory pressure meter.

Secondary Outcome Measures

Name	Time	Method
Days of hospitalization.	At discharge (average of 8 days).
Dyspnea scale questionnaire	At baseline, at discharge, 6 months and one year later.
Quality of life	At baseline, 6 months and one year later.
Blood gases	At baseline and at discharge (average of 8 days).
Number of hospital readmissions in the next year	At one year after discharge (average of 8 days).

Trial Locations

Locations (1)

Hospital del Mar (Servei de Pneumología); 🇪🇸 Barcelona, Spain