Respiratory Muscle Function in COPD Exacerbations

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Non-invasive ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Estirado, PhD; Phone Number: 932483138; Email: 97623@parcdesalutmar.cat

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar (Servei de Pneumología)
    • Contact: Cristina Estirado, PhD; Phone Number: 0034932483138; Email: 97623@parcdesalutmar.cat
    • Principal Investigator: Cristina Estirado, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard treatment; Standard treatment consists in bronchodilator and parenteral corticosteroids and oxygen therapy.
Experimental: Standard treatment plus non-invasive ventilation; This arm consists in bronchodilator and parenteral corticosteroids and oxygen therapy plus non-invasive ventilation.	Device: Non-invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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).

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: May 31, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Estimate): June 5, 2013
• Last Update Submitted That Met QC Criteria: May 31, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CRISOL-MARTINA-2013