Chronic Respiratory FailurePhase 4NCT00698958
Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
A Phase 4 study testing Ambulatory adaptation to non- invasive mechanical ventilation for 7 days and Hospital based adaptation to non- invasive mechanical ventilation for 7 days in people with Chronic Respiratory Failure, run by Hospital Clinic of Barcelona.
Trial summary
A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive mechanical ventilation in patient with hypercapnic respiratory failure secondary to neuromuscular diseases or alterations in thoracic cage in comparison with hospital adaptation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Respiratory Failure
- What is being tested?
- Ambulatory adaptation to non- invasive mechanical ventilation for 7 days and Hospital based adaptation to non- invasive mechanical ventilation for 7 days
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to not given
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75
- Chronic respiratory insufficiency secondary to neuromuscular disease or thoracic cage alterations with indication of non-invasive mechanical ventilation (presence of fatigue, dyspnea, morning headache, etc) plus one of the following criteria):
- PaCO2 > 45 mmHg
- Night time oxygen saturation < 88% at least for 5 consecutive minutes
- In neuromuscular diseases, PIM < 60 cmH2O or FVC < 50% of theoretical.
- Stable disease.
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- Airway access through nasal mask.
- Ability to provide written informed consent.
- Ability to attend the visits
Who cannot join
- Contraindications for mechanical ventilation:
- Patient with terminal disease or vegetative state
- Lack of motivation of the patient
- Lack of family or social support
- Patients clinically unstable
- Agitation or lack of co-operation
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- Depression.
- Patients with acute symptoms requiring hospital admission.
- Need for airway access through tracheostomy, face mask or mouth piece.
- Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.
- Use (for 7 days or more) of CNS depressors(benzodiazepines, antihistamines H1, tricyclic antidepressants , antiepileptic or antipsychotic drugs ) in the 30-day period prior to inclusion, or expected need for such drugs during the study.
- Lack of understanding of the study procedures.
About this study
Official title: A Randomized Trial to Compare the Effectiveness of Hospital or Ambulatory Approach for Adaptation to Non-Invasive Mechanical Ventilation in Patients With Chronic Respiratory Failure Secondary to Neuromuscular Diseases or Thoracic Cage Alterations
A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive mechanical ventilation in patient with hypercapnic respiratory failure secondary to neuromuscular diseases or alterations in thoracic cage in comparison with hospital adaptation.
- Conditions
- Chronic Respiratory Failure
- Being tested
- Ambulatory adaptation to non- invasive mechanical ventilation for 7 days, Hospital based adaptation to non- invasive mechanical ventilation for 7 days
- Keywords
- Respiratory insufficiency, Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory adaptation to non- invasive mechanical ventilation for 7 daysProcedure or surgery
Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Hospital based adaptation to non- invasive mechanical ventilation for 7 daysProcedure or surgery
Hospital based adaptation to non- invasive mechanical ventilation for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Hospital based adaptation to non- invasive mechanical ventilation for 7 days Receives: Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days |
| 2 | Experimental | Ambulatory adaptation to non- invasive mechanical ventilation for 7 days Receives: Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaCO2 from baseline
Measured: 6 months
Secondary outcomes (3)
Change in PaCO2 from start of mechanical ventilation
6-minute walking test
Adaptation failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698958
- Sponsor's protocol ID
- NEUMO/2002/01
- Status last verified
- Jun 2008
- First submitted
- 13 Jun 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Pallero M, Puy C, Guell R, Pontes C, Marti S, Torres F, Anton A, Munoz X. Ambulatory adaptation to noninvasive ventilation in restrictive pulmonary disease: a randomized trial with cost assessment. Respir Med. 2014 Jul;108(7):1014-22. doi: 10.1016/j.rmed.2014.04.016. Epub 2014 May 2.
PubMed 24837977
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Compare the Effectiveness of Hospital or Ambulatory Approach for Adaptation to Non-Invasive Mechanical Ventilation in Patients With Chronic Respiratory Failure Secondary to Neuromuscular Diseases or Thoracic Cage Alterations
- ClinicalTrials.gov ID
- NCT00698958
- Acronym / sponsor ID
- NEUMO/2002/01
- Conditions
- Chronic Respiratory Failure
- Keywords
- Respiratory insufficiency, Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Hospital Universitari Vall d'Hebron Research Institute, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- Jun 2003
- First posted
- 17 Jun 2008 (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.
A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive mechanical ventilation in patient with hypercapnic respiratory failure secondary to neuromuscular diseases or alterations in thoracic cage in comparison with hospital adaptation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 daysHospital based adaptation to non- invasive mechanical ventilation for 7 days |
| 2 | Experimental | Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 daysAmbulatory adaptation to non- invasive mechanical ventilation for 7 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 75
- Chronic respiratory insufficiency secondary to neuromuscular disease or thoracic cage alterations with indication of non-invasive mechanical ventilation (presence of fatigue, dyspnea, morning headache, etc) plus one of the following criteria):
- Stable disease.
- Airway access through nasal mask.
- Ability to provide written informed consent.
Key exclusion criteria (12 listed)
- Contraindications for mechanical ventilation:
- Patients with acute symptoms requiring hospital admission.
- Need for airway access through tracheostomy, face mask or mouth piece.
- Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.
- Use (for 7 days or more) of CNS depressors(benzodiazepines, antihistamines H1, tricyclic antidepressants , antiepileptic or antipsychotic drugs ) in the 30-day period prior to inclusion, or expected need for such drugs during the study.
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 |
|---|---|---|
| Ambulatory adaptation to non- invasive mechanical ventilation for 7 daysAmbulatory adaptation to non- invasive mechanical ventilation for 7 days | Procedure or surgery | 2 |
| Hospital based adaptation to non- invasive mechanical ventilation for 7 daysHospital based adaptation to non- invasive mechanical ventilation for 7 days | Procedure or surgery | 1 |
Primary outcome
Change in PaCO2 from baseline
Time frame: 6 months
3 secondary outcomes
Change in PaCO2 from start of mechanical ventilation
6-minute walking test
Adaptation failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
- Derived from this study: PubMed 24837977Pallero M, Puy C, Guell R, Pontes C, Marti S, Torres F, Anton A, Munoz X. Ambulatory adaptation to noninvasive ventilation in restrictive pulmonary disease: a randomized trial with cost assessment. Respir Med. 2014 Jul;108(7):1014-22. doi: 10.1016/j.rmed.2014.04.016. Epub 2014 May 2.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ambulatory adaptation to non- invasive mechanical ventilation for 7 days and Hospital based adaptation to non- invasive mechanical ventilation for 7 days in people with Chronic Respiratory Failure, run by Hospital Clinic of Barcelona.
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 9 inclusion and 12 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: finished, as of the sponsor's last update on 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in PaCO2 from baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00698958, which also lists 1 linked publication.
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 17 Jun 2008.