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Home Mechanical Ventilation Effectiveness and Air Leaks

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090986
First Posted: March 23, 2010
Last Update Posted: February 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  Purpose
Non invasive ventilation (NIV) usually presents air leaks that may determine the result of this treatment. The clinical usefulness of analyzing (and quantifying) these leaks during the adaptation period to NIV has not been evaluated in prospective clinical studies as a predictive data of treatment effectiveness. Our hypothesis is that air leaks are correlated to a successful adaptation to NIV. And air leak magnitude may predict early failures of this treatment. And also, as we do not know if air leaks change during the adaptation period to NIV, we do not know whether early detection of air leaks plays a role in the therapeutic outcome. Our objective is to evaluate the clinical usefulness of quantifying air leaks during the adaptation period to NIV as a predictor of effectiveness of this treatment. We also want to evaluate the correlation between air leaks and clinical-functional patients' profile, and the ventilatory parameters selected and to evaluate air leaks variability during the adaptation period to NIV. Method: We will determine the air leak magnitude in twenty patients during adaptation to NIV. We will use VPAP III ventilators (ResMed, Australia), commercial nasal masks (Mirage o Ultra Mirage) and VPAP III/ResLinkTM (ResMed, North Ryde, Australia), a device that includes a monitoring system coupled with the VPAP III ventilator. This device allows to record air leaks and other ventilation parameters. We will perform four VPAP III/ResLinkTM recordings in each patient (the last night in hospital during the adaptation period, the first night at home, and one and two months later, after the initiation of NIV treatment). We will also perform a complete pulmonary function test, quality-of-life questionnaire (SF36), and a tolerance to NIV questionnaire in all patients at the onset of NIV treatment and two months later. We will evaluate which patients will need to change treatment at the end of the adaptation period to NIV. We also will analyze and compare air leaks magnitude in each of the four recordings stated above.

Condition
Pulmonary Disease Chronic Respiratory Failure COPD

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction of Home Mechanical Ventilation Effectiveness by Means of Non-controlled Air Leaks Estimation.

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • - 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 ]

Enrollment: 20
Study Start Date: June 2006
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with a restrictive pulmonary disease and hypercapnic chronic respiratory failure with standard criteria for NIV. Also COPD patients who need NIV because of another reason (obesity, nocturnal hyperventilation or nocturnal hypercapnic response to oxygen).

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • 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.
  • Also COPD patients who need NIV because of another reason (obesity, nocturnal hyperventilation or nocturnal hypercapnic response to oxygen).
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090986


Locations
Spain
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Carme Puy, MD Hospital Santa Creu i Sant Pau
  More Information

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01090986     History of Changes
Other Study ID Numbers: PR02/02/2007
First Submitted: March 19, 2010
First Posted: March 23, 2010
Last Update Posted: February 24, 2014
Last Verified: February 2014

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Restrictive pulmonary disease with hypercapnic chronic respiratory failure.
COPD patients who need NIV hypercapnic chronic respiratory failure.

Additional relevant MeSH terms:
Lung Diseases
Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders