Chronic Obstructive Pulmonary Disease (COPD)NCT01869387
Respiratory Muscle Function in COPD Exacerbations
A study testing Non-invasive ventilation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Parc de Salut Mar at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital del Mar (Servei de Pneumología)
Barcelona, Barcelona, 08003
Cristina Estirado, PhD, 0034932483138, 97623@parcdesalutmar.cat
Cristina Estirado, PhD
About this study
Official title: 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.
- Being tested
- Non-invasive ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle function.
Measurement of maximal inspiratory pressure and sniff nasal inspiratory pressure using a portable respiratory pressure meter.
Measured: At baseline, at discharge (average of 8 days), 6 months and one year later.
Secondary outcomes (5)
Days of hospitalization.
Measured: At discharge (average of 8 days).
Dyspnea scale questionnaire
Measured: At baseline, at discharge, 6 months and one year later.
Quality of life
Measured: At baseline, 6 months and one year later.
Blood gases
Measured: At baseline and at discharge (average of 8 days).
Number of hospital readmissions in the next year
Measured: At one year after discharge (average of 8 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869387
- Sponsor's protocol ID
- CRISOL-MARTINA-2013
- Status last verified
- May 2013
- First submitted
- 27 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Respiratory Muscle Function With Noninvasive Ventilation in Exacerbated COPD Patients Presenting Hypercapnic Respiratory Failure Without Acidosis
- ClinicalTrials.gov ID
- NCT01869387
- Acronym / sponsor ID
- CRISOL-MARTINA-2013
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –Standard treatment consists in bronchodilator and parenteral corticosteroids and oxygen therapy. |
| Standard treatment plus non-invasive ventilation | Experimental | Device: Non-invasive ventilationThis arm consists in bronchodilator and parenteral corticosteroids and oxygen therapy plus non-invasive ventilation. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilation | Device | Standard treatment plus non-invasive ventilation |
Primary outcome
Respiratory muscle function.
Time frame: 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.
5 secondary outcomes
Days of hospitalization.
Time frame: At discharge (average of 8 days).
Dyspnea scale questionnaire
Time frame: At baseline, at discharge, 6 months and one year later.
Quality of life
Time frame: At baseline, 6 months and one year later.
Blood gases
Time frame: At baseline and at discharge (average of 8 days).
Number of hospital readmissions in the next year
Time frame: At one year after discharge (average of 8 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Estirado, PhD (932483138, 97623@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle function. (time frame: At baseline, at discharge (average of 8 days), 6 months and one year later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.