Respiratory Muscle Function in COPD Exacerbations

NCT01869387 | Unknown

• 1 other identifier: CRISOL-MARTINA-2013
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Respiratory muscle function.

  Measurement of maximal inspiratory pressure and sniff nasal inspiratory pressure using a portable respiratory pressure meter.

  At baseline, at discharge (average of 8 days), 6 months and one year later.

Secondary Outcomes (5)

• 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).

Study Arms (2)

Standard treatment

NO INTERVENTION

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

Standard treatment plus non-invasive ventilation

EXPERIMENTAL

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

Device: Non-invasive ventilation

Interventions

Non-invasive ventilation DEVICE

Standard treatment plus non-invasive ventilation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD according to international guidelines ( GOLD)
• COPD exacerbation requiring hospitalization
• Initial blood gases: PaCO2\> 50 mm Hg and pH\> 7.35.

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar (Servei de Pneumología)

Barcelona, Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Cristina Estirado, PhD

CONTACT

932483138; 97623@parcdesalutmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 5, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 5, 2013

Record last verified: 2013-05

Locations

ES (1)