Chronic Obstructive Pulmonary DiseaseNCT01120574
Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypercapnic Response
A study testing Home mechanical ventilation in people with Chronic Obstructive Pulmonary Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the clinical benefits of home mechanical ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen administration. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Home mechanical ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2005to 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elderly patients < 80 years old.
- COPD (ERS/ATS (FEV1 < 80%, FEV1/FVC < 70%, TLC > 80%)).
- Oxygen therapy indication (PaO2 < 55 mmHg or 55-59 associated to pulmonary arterial hypertension, chronic Cor Pulmonale, Chronic Heart failure, arrhythmias or polyglobulia).
- PaCO2 > 50 mm Hg.
- Clinically stable at least prior to one month.
- Hypercapnic response: increasing PaCO2 > 10 mmHg at 7 a.m after all night with oxygen compared with PaCO2 when awake and without oxygen therapy.
Who cannot join
- Active smoker.
- Bronchiectasis or tuberculous after-effects.
- Chronic respiratory failure secondary to thorax cage or neuromuscular diseases.
- BMI > 35 kg/m2
- OSAS.
- Locomotor system problems that disable 6 minutes walking test execution.
- Patients with tracheostomy.
- Other serious comorbidity (i.e chronic heart failure functional class > II NYHA, cancer or chronic renal failure that requires dialysis.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Institu de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
About this study
Official title: Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Develop Nocturnal Hypercapnic Response Associated to Oxygen Therapy
The objective of this study is to evaluate the clinical benefits of home mechanical ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen administration.
We will include clinically stable COPD patients with hypercapnic CRF who develop a nocturnal hypercapnic response to oxygen (PaCO2 increase on awakening, at night with oxygen, >10 mmHg respect to PaCO2 breathing room air and awake). Obstructive sleep apnoea syndrome (OSAS) will previously have been excluded.
Read more
Patients will be admitted to the Pneumology ward where a nocturnal pulsioxymetry breathing oxygen therapy will be performed. Arterial blood gas samples will be taken at awakening (7AM).
Patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment groups:
- Oxygen therapy group
- Home mechanical ventilation plus oxygen therapy group Home mechanical ventilation will be performed with a bilevel pressure ventilator. Functional respiratory variables as well as quality of life and sleep at onset and after 6 months treatment will be compared.
The principal outcome will be the evolution of arterial blood gases (PaCO2) between the two groups.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Home mechanical ventilation
- Keywords
- Nocturnal hypercapnic response to oxygen, Home mechanical ventilation, COPD
- 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.
Home mechanical ventilationOther
Home mechanical ventilation will be performed with a bilevel pressure ventilator.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Oxygen therapy group. |
| 2 | Active comparator | Home mechanical ventilation plus oxygen therapy group. Receives: Other: Home mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial pressure of CO2.
Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment.
Measured: Six months
Secondary outcomes (3)
Functional respiratory tests.
Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
Measured: Six months
Quality of life related to health
Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
Measured: 6 months
Nocturnal hypoventilation (nocturnal pulseoxymetry)
Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startOct 2005
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120574
- Sponsor's protocol ID
- PR05/05/2007
- Status last verified
- Mar 2017
- First submitted
- 19 Mar 2010
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Develop Nocturnal Hypercapnic Response Associated to Oxygen Therapy
- ClinicalTrials.gov ID
- NCT01120574
- Acronym / sponsor ID
- PR05/05/2007
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Nocturnal hypercapnic response to oxygen, Home mechanical ventilation, COPD
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Oct 2005 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 May 2010 (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.
The objective of this study is to evaluate the clinical benefits of home mechanical ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen administration.
We will include clinically stable COPD patients with hypercapnic CRF who develop a nocturnal hypercapnic response to oxygen (PaCO2 increase on awakening, at night with oxygen, >10 mmHg respect to PaCO2 breathing room air and awake). Obstructive sleep apnoea syndrome (OSAS) will previously have been excluded.
Patients will be admitted to the Pneumology ward where a nocturnal pulsioxymetry breathing oxygen therapy will be performed. Arterial blood gas samples will be taken at awakening (7AM).
Patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment groups:
- Oxygen therapy group
- Home mechanical ventilation plus oxygen therapy group Home mechanical ventilation will be performed with a bilevel pressure ventilator. Functional respiratory variables as well as quality of life and sleep at onset and after 6 months treatment will be compared.
The principal outcome will be the evolution of arterial blood gases (PaCO2) between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Oxygen therapy group. |
| 2 | Active comparator | Other: Home mechanical ventilationHome mechanical ventilation plus oxygen therapy group. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Elderly patients < 80 years old.
- COPD (ERS/ATS (FEV1 < 80%, FEV1/FVC < 70%, TLC > 80%)).
- Oxygen therapy indication (PaO2 < 55 mmHg or 55-59 associated to pulmonary arterial hypertension, chronic Cor Pulmonale, Chronic Heart failure, arrhythmias or polyglobulia).
- PaCO2 > 50 mm Hg.
- Clinically stable at least prior to one month.
Key exclusion criteria (8 listed)
- Active smoker.
- Bronchiectasis or tuberculous after-effects.
- Chronic respiratory failure secondary to thorax cage or neuromuscular diseases.
- BMI > 35 kg/m2
- OSAS.
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 |
|---|---|---|
| Home mechanical ventilationHome mechanical ventilation will be performed with a bilevel pressure ventilator. | Other | 2 |
Primary outcome
Arterial pressure of CO2.
Time frame: Six months
Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment.
3 secondary outcomes
Functional respiratory tests.
Time frame: Six months
Quality of life related to health
Time frame: 6 months
Nocturnal hypoventilation (nocturnal pulseoxymetry)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home mechanical ventilation in people with Chronic Obstructive Pulmonary Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 22 Mar 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial pressure of CO2. (time frame: Six months). 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 22 Mar 2017.