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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01090986 |
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Date of registration:
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19/03/2010 |
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Primary sponsor: |
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Public title:
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Home Mechanical Ventilation Effectiveness and Air Leaks
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Scientific title:
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Prediction of Home Mechanical Ventilation Effectiveness by Means of Non-controlled Air Leaks Estimation. |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01090986 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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Spain
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Contacts
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Name:
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Pedro A Anton Albisu, Medical Doctor |
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Address:
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Telephone:
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+034935575972 |
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Email:
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PAnton@santpau.cat |
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Affiliation:
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Name:
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Pedro A Anton Albisu, Medical doctor |
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Address:
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Telephone:
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+034935575972 |
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Email:
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PAnton@santpau.cat |
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Affiliation:
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Name:
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Carme Puy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Santa Creu i Sant Pau |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a restrictive pulmonary disease (slow evolution neuromuscular or thorax
cage diseases, obesity or nocturnal hypoventilation) and hypercapnic chronic
respiratory failure with standard criteria for NIV.
- COPD patients who need NIV because of another reason (obesity, nocturnal
hyperventilation or nocturnal hypercapnic response to oxygen).
- PaCO2 = de 50 mmHg.
- Clinically stable (at least for one month).
- Possibility to fit a nasal mask for NIV treatment (ultra mirage, mirage).
Exclusion Criteria:
- Rapid evolution neuromuscular disease (Amyotrophic Lateral Sclerosis).
- Serious comorbidity.
- Lack of patients comprehension or collaboration.
- Inability to fit a nasal mask for NIV treatment (ultra mirage, mirage).
- Treatment compliance < 4h/d.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Respiratory Failure
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COPD
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Pulmonary Disease
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Primary Outcome(s)
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Clinical usefulness of quantifying AIR LEAKS during the adaptation period to NIV as a predictor of effectiveness (pCO2 EVOLUTION) of this treatment.
[Time Frame: One year]
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Secondary Outcome(s)
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- Air leaks AND patients' characteristics.- Some indices (air leaks/inspiratory pressure...)and NIV effectiveness. - Air leak evolution.- Air leaks and patients' tolerance to NIV.
[Time Frame: One year]
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Secondary ID(s)
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PR02/02/2007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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