Respiratory Muscle Function in COPD Exacerbations

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Improvement of Respiratory Muscle Function With Noninvasive Ventilation in Exacerbated COPD Patients Presenting Hypercapnic Respiratory Failure Without Acidosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01869387
• Other study ID #: CRISOL-MARTINA-2013
• Status: Not yet recruiting
• Phase: N/A
• First received: May 27, 2013
• Last updated: May 31, 2013
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2013
• Source: Parc de Salut Mar
• Contact: Cristina Estirado, PhD
• Phone: 932483138
• Email: 97623[@]parcdesalutmar.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Non-invasive ventilation

Locations

Country	Name	City	State
Spain	Hospital del Mar (Servei de Pneumología)	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Days of hospitalization.		At discharge (average of 8 days).	No
Secondary	Dyspnea scale questionnaire		At baseline, at discharge, 6 months and one year later.	No
Secondary	Quality of life		At baseline, 6 months and one year later.	No
Secondary	Blood gases		At baseline and at discharge (average of 8 days).	No
Secondary	Number of hospital readmissions in the next year		At one year after discharge (average of 8 days).	No